HIV Infections
Conditions
Brief summary
This study will evaluate the safety, pharmacokinetics, and antiviral activity of VRC-HIVMAB060-00-AB (VRC01) and VRC-HIVMAB080-00-AB (VRC01LS) in the serum and mucosa of healthy, HIV-uninfected adults.
Detailed description
This study will evaluate two experimental human monoclonal antibodies (mAbs): VRC-HIVMAB060-00-AB (VRC01) and VRC-HIVMAB080-00-AB (VRC01LS). VRC01LS is designed to have a longer half-life than VRC01. The purpose of this study is to evaluate the safety, pharmacokinetics, and antiviral activity of VRC01 and VRC01LS in the serum and mucosa of healthy, HIV-uninfected adults. This study will enroll healthy, HIV-uninfected adults into five groups. At various time points during the study, participants in Groups 1, 2, and 4 will receive intravenous (IV) infusions of VRC01, and participants in Groups 3 and 5 will receive IV infusions of VRC01LS. Participants in Groups 1, 2, and 3 will attend 13 to 14 study visits over about 1 to 1 ½ years; participants in Groups 4 and 5 will attend 7 to 9 study visits over about 6 months to 1 year. At certain time points, study visits will include physical examinations, blood collection, urine collection, and interviews and questionnaires. At other time points, depending on group assignment and gender, visits will also include collection of cervicovaginal secretions, rectal secretions, and semen; and cervical, vaginal, and rectal biopsies.
Interventions
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
General and Demographic Criteria: * Age of 18 to 50 years * Weight less than or equal to 115 kg * Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (CRS) and willingness to be followed for the planned duration of the study * Ability and willingness to provide informed consent * Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to enrollment with verbal demonstration of understanding of all questionnaire items answered incorrectly * Agrees not to enroll in another study of an investigational research agent until completion of the last study visit * Good general health as shown by medical history, physical exam, and screening laboratory tests HIV-Related Criteria: * Willingness to receive HIV test results * Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling * Assessed by the clinic staff as being at low risk for HIV infection \[low risk guidelines are found on the protocol home page on the HVTN Members' site (https://members.hvtn.org/protocols/hvtn116)\] and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit Laboratory Inclusion Values: Hemogram/CBC * Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were born female, greater than or equal to 13.0 g/dL for volunteers who were born male * White blood cell count equal to 2,500 to 12,000 cells/mm\^3 * Total lymphocyte count greater than or equal to 800 cells/mm\^3 * Remaining differential either within institutional normal range or with site physician approval * Platelets equal to 125,000 to 550,000/mm\^3 Chemistry * Chemistry panel: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase less than 1.25 times the institutional upper limit of normal; creatinine less than or equal to institutional upper limit of normal Virology * Negative HIV-1 and -2 blood test: U.S. volunteers must have a negative Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA). Non-U.S. sites may use locally available assays that have been approved by HVTN Laboratory Operations. * Negative hepatitis B surface antigen (HBsAg) * Negative anti-hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive Urine * Normal urine: * Negative urine glucose, and * Negative or trace urine protein, and * Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a microscopic urinalysis with red blood cells levels within institutional normal range) Reproductive Status: * Volunteers who were born female: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to initial biopsy for groups 1-3 and prior to initial infusion for groups 4-5 on the day of enrollment. Persons who are NOT of reproductive potential due to having undergone bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing. Reproductive Status: United States: A volunteer who was born female must: * Agree to consistently use effective contraception (see the protocol for more information) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit. Effective contraception is defined as using the following methods: * Condoms (male or female) with or without a spermicide, * Diaphragm or cervical cap with spermicide, * Intrauterine device (IUD), * Hormonal contraception, or * Any other contraceptive method approved by the HVTN 116 Protocol Safety Review Team (PSRT) * Successful vasectomy in the male partner (considered successful if a volunteer reports that a male partner has \[1\] documentation of azoospermia by microscopy, or \[2\] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy); * Or not be of reproductive potential, such as having had a bilateral oophorectomy, or tubal ligation; * Or be sexually abstinent. South Africa: A volunteer who was born female must: * Agree to consistently use effective contraception (see the protocol for more information) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit. Effective contraception for participants in South Africa is defined as using 2 methods of birth control. ONE barrier contraceptive method: * Condoms (male or female) * Diaphragm or cervical cap PLUS ONE of the following methods: * Intrauterine device (IUD), * Hormonal contraception, or * Successful vasectomy in the male partner (considered successful if a volunteer reports that a male partner has \[1\] documentation of azoospermia by microscopy, or \[2\] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy), or * Any other contraceptive method approved by the HVTN 116 PSRT Or not be of reproductive potential, such as having had a bilateral oophorectomy, or tubal ligation; Or be sexually abstinent. * Volunteers who were born female must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit Mucosal Specimen Collection * Volunteers 21 years of age and older who were born female: Pap smear (verified by medical records) is required within: * the 3 years prior to enrollment with the latest result reported as normal or ASCUS (atypical squamous cells of undetermined significance), OR * the 5 years prior to enrollment, with the latest result reported as normal, or ASCUS with no evidence of high risk HPV. * If no Pap smear was done within the last 3 years (or within the last 5 years, if high risk HPV testing was performed), the volunteer must be willing to undergo a Pap smear with the result reported (verified by medical records) as normal or ASCUS prior to sample collection. * Willing to have mucosal secretions and tissue biopsies collected * Willing to abstain from sexual intercourse for the required period after each biopsy collection
Exclusion criteria
General * Blood products received within 120 days before first infusion, unless eligibility for earlier enrollment is determined by the HVTN 116 PSRT * Investigational research agents received within 30 days before first infusion * Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing during the planned duration of the HVTN 116 study * Pregnant or breastfeeding * Active duty U.S. military personnel with the potential of being deployed during the study Vaccines and Other Injections * HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 116 PSRT will determine eligibility on a case-by-case basis. * Non-HIV experimental vaccine(s) received within the last 6 months in a prior vaccine trial. Exceptions may be made for some vaccines and vaccine trials. For volunteers who have received an experimental vaccine(s) less than 6 months ago, eligibility for enrollment will be determined by the HVTN 116 PSRT on a case-by-case basis. * Live attenuated vaccines other than influenza vaccine received within 10 days before first infusion or scheduled within 10 days after first infusion (e.g., measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever) * Previous receipt of humanized or human mAbs whether licensed or investigational Immune System * Immunosuppressive medications received within 30 days before first infusion. (Not exclusionary: \[1\] corticosteroid nasal spray; \[2\] inhaled corticosteroids; or \[3\] topical corticosteroids for mild, uncomplicated dermatitis) * Serious adverse reactions to VRC01 and VRC01LS formulation components such as sodium citrate, sodium chloride, and L-arginine hydrochloride, including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain * Autoimmune disease (Not exclusionary: mild, well-controlled psoriasis) * Immunodeficiency Clinically Significant Medical Conditions * Untreated or incompletely treated syphilis infection * Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to: * A process that would affect the immune response, * A process that would require medication that affects the immune response, * Any contraindication to repeated infusions or blood draws, including perceived inability to establish venous access * A condition that requires regular use of any anticoagulant medications (not including aspirin or NSAIDs), * A condition that requires active medical intervention or monitoring to avert grave danger to the volunteer's health or well-being during the study period, * A condition or process for which signs or symptoms could be confused with reactions to study product, or * Any condition specifically listed among the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Measured through 6 months after the last infusion | Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels and total protein levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the protein-normalized VRC01/VRC01LS levels performed by dividing VRC01/LS levels (pg/mL) by the total protein concentrations (ng/mL) |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Measured through 3 days after each infusion at months 0, 2, 3, 4 or 6 (infusion visits depending on which group participants are in) | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\] The maximum grade observed for each symptom over the time frame is presented. |
| Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Measured through 3 days after each infusion at months 0, 2, 3, 4 or 6 (infusion visits depending on which group participants are in) | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\] The maximum grade observed for each symptom over the time frame is presented. |
| Chemistry and Hematology Laboratory Measures | Measured through IV infusion at visits 1 (screening), 4 (day 1-15), 7 (day 57-71), 10 (day 99-113), 12 (day 127-141), 14 (day 169-183), 16 (day 252-267), and 18 (day 442-456) (visits depending on which group participants are in) | alkaline phosphate (ALP) (U/L), aspartate aminotransferase (AST) (U/L), alanine aminotransferase (ALT) (U/L) (Doesn't mention about lab grade \> 1 ) |
| Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Measured through IV infusion at visits 1 (screening), 4 (day 1-15), 7 (day 57-71), 10 (day 99-113), 12 (day 127-141), 14 (day 169-183), 16 (day 252-267), and 18 (day 442-456) (visits depending on which group participants are in) | Chemistry and Hematology Laboratory Measures - creatinine (g/dl), hemoglobin (g/dl) |
| Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Measured through IV infusion at visits 1 (screening), 4 (day 1-15), 7 (day 57-71), 10 (day 99-113), 12 (day 127-141), 14 (day 169-183), 16 (day 252-267), and 18 (day 442-456) (visits depending on which group participants are in) | Chemistry and Hematology Laboratory Measures - lymphocyte count (1000/mm3), neutrophil count (1000/mm3), platelets (1000/mm3), white blood cells (WBC) (1000/mm3) |
| Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Measured through IV infusion at visits 1 (screening), 4 (day 1-15), 7 (day 57-71), 10 (day 99-113), 12 (day 127-141), 14 (day 169-183), 16 (day 252-267), and 18 (day 442-456) (visits depending on which group participants are in) | Number of Participants with Chemistry and Hematology Laboratory Measures - Counts of Lab Grade \> 1 for alkaline phosphate (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC). |
| Number of Participants Reporting Adverse Events (AEs) | Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in) | For participants reporting multiple AEs over the time frame, the maximum severity is counted |
| Number of Participants Reporting Serious Adverse Events (SAEs) | Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in) | For participants reporting multiple AEs over the time frame, the maximum severity is counted |
| Rates of Participant Discontinuation | Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in) | Tabulated by reason for discontinuation and treatment arm |
| Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Measured through 6 months after the last infusion | Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the estimated concentration of VRC01/VRC01LS. |
| IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Measured through 6 months after the last infusion | Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels and total IgG levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the IgG-normalized VRC01/VRC01LS levels performed by dividing VRC01/LS levels (pg/mL) by the total IgG concentrations (ng/mL) |
| Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Measured through 6 months after the last infusion | Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels and total protein levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the protein-normalized VRC01/VRC01LS levels performed by dividing VRC01/LS levels (pg/mL) by the total protein concentrations (ng/mL) |
| Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Measured through 6 months after the last infusion | Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the estimated concentration of VRC01/VRC01LS. |
| IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Measured through 6 months after the last infusion | Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels and total IgG levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the IgG-normalized VRC01/VRC01LS levels performed by dividing VRC01/LS levels (pg/mL) by the total IgG concentrations (ng/mL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Cervical biopsies collected at visits 2 and 14; Rectal biopsies collected at visits 2, 14, 15, 16, 17, 18, 19 (19 not apply for Du422.1); Vaginal biopsies collected at visits 2 and 14, 15, 16, 17. RLU measured every 3 days, during culture days 3-21. | Magnitudes of ex vivo HIV-1 infection were measured by the tissue luminescence assay (TLA). Susceptibility to viral infection in the ex vivo challenge assay is summarized by the area under the viral infectivity curve (AUC) based on log-transformed RLU values between 3-21 days of culture, indicated as AUCday3-21. |
Countries
South Africa, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Vaccine VRC01 10 mg/kg mo(0,2,4,6) | 23 |
| Group 2: Vaccine VRC01 30 mg/kg mo(0,2,4,6) | 23 |
| Group 3: Vaccine VRC01LS 30 mg/kg mo(0,3,6) | 7 |
| Group 4: Vaccine VRC01 30 mg/kg mo(0) | 16 |
| Group 5: Vaccine VRC01LS 30 mg/kg mo(0) | 10 |
| Group 6: Pre-treatment Biopsy collected but was not randomized to any treatment group | 1 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 | 2 | 1 | 2 | 0 |
| Overall Study | Not Randomized | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Participant unable to adhere | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Group 2: Vaccine | Group 3: Vaccine | Group 1: Vaccine | Group 4: Vaccine | Group 5: Vaccine | Group 6: Pre-treatment |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 29 years | 27 years | 33 years | 31 years | 30 years | 30 years | 34 years |
| Age, Customized 18 - 20 years | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants |
| Age, Customized 21 - 30 years | 42 Participants | 16 Participants | 3 Participants | 11 Participants | 7 Participants | 5 Participants | 0 Participants |
| Age, Customized 31 - 40 years | 27 Participants | 5 Participants | 3 Participants | 7 Participants | 7 Participants | 4 Participants | 1 Participants |
| Age, Customized 41 - 50 years | 9 Participants | 2 Participants | 1 Participants | 5 Participants | 0 Participants | 1 Participants | 0 Participants |
| Age, Customized Above 50 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Less than 18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 79 Participants | 23 Participants | 7 Participants | 22 Participants | 16 Participants | 10 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 35 Participants | 12 Participants | 5 Participants | 12 Participants | 4 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 3 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 36 Participants | 6 Participants | 2 Participants | 9 Participants | 11 Participants | 8 Participants | 0 Participants |
| Region of Enrollment South Africa | 26 Participants | 11 Participants | 4 Participants | 10 Participants | 0 Participants | 0 Participants | 1 Participants |
| Region of Enrollment USA | 54 Participants | 12 Participants | 3 Participants | 13 Participants | 16 Participants | 10 Participants | 0 Participants |
| Sex: Female, Male Female | 43 Participants | 13 Participants | 3 Participants | 13 Participants | 8 Participants | 6 Participants | 0 Participants |
| Sex: Female, Male Male | 37 Participants | 10 Participants | 4 Participants | 10 Participants | 8 Participants | 4 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 23 | 0 / 7 | 0 / 16 | 0 / 10 | 0 / 1 |
| other Total, other adverse events | 22 / 23 | 18 / 23 | 7 / 7 | 7 / 16 | 3 / 10 | 1 / 1 |
| serious Total, serious adverse events | 0 / 23 | 1 / 23 | 1 / 7 | 0 / 16 | 1 / 10 | 0 / 1 |
Outcome results
Primary
Chemistry and Hematology Laboratory Measures
alkaline phosphate (ALP) (U/L), aspartate aminotransferase (AST) (U/L), alanine aminotransferase (ALT) (U/L) (Doesn't mention about lab grade \> 1 )
Time frame: Measured through IV infusion at visits 1 (screening), 4 (day 1-15), 7 (day 57-71), 10 (day 99-113), 12 (day 127-141), 14 (day 169-183), 16 (day 252-267), and 18 (day 442-456) (visits depending on which group participants are in)
Population: Visit schedule is not the same for each treatment group. For visits not on the schedule, number analyzed is 0 and median/IQR is ---.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | Alkaline Phosphatase (U/L)- Day 169 - 183 | 68.5 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | AST (U/L)- Day 169 - 183 | 19 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | AST (U/L)- Day 1 - 15 | 19 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | AST (U/L)- Day 127 - 141 | 19.5 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | AST (U/L)- Day 57 - 71 | 18 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)- Screening | 16 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | Alkaline Phosphatase (U/L)- Day 127 - 141 | 68 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)- Day 1 - 15 | 15 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | Alkaline Phosphatase (U/L)- Day 57 - 71 | 67 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | Alkaline Phosphatase (U/L)- Day 1 - 15 | 65 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)- Day 57 - 71 | 15 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)- Day 127 - 141 | 15.5 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)- Day 169 - 183 | 16 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | AST (U/L)- Day 252 - 267 | 18.5 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)- Day 252 - 267 | 15.5 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | Alkaline Phosphatase (U/L)- Day 252 - 267 | 68 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | Alkaline Phosphatase (U/L)- Screening | 65 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | AST (U/L)- Screening | 20 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)- Day 252 - 267 | 19 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | AST (U/L)- Day 169 - 183 | 20.5 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)- Day 169 - 183 | 15.5 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | AST (U/L)- Day 127 - 141 | 21 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | Alkaline Phosphatase (U/L)- Day 252 - 267 | 59 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | AST (U/L)- Day 1 - 15 | 20 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | Alkaline Phosphatase (U/L)- Day 127 - 141 | 67.5 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)- Day 57 - 71 | 16 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | AST (U/L)- Day 57 - 71 | 19 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | Alkaline Phosphatase (U/L)- Day 169 - 183 | 63 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | AST (U/L)- Screening | 20 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)- Screening | 16 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | AST (U/L)- Day 252 - 267 | 20 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)- Day 127 - 141 | 18.5 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | Alkaline Phosphatase (U/L)- Day 57 - 71 | 67 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | Alkaline Phosphatase (U/L)- Screening | 61 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)- Day 1 - 15 | 15 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | Alkaline Phosphatase (U/L)- Day 1 - 15 | 60 U/L |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures | AST (U/L)- Day 442 - 456 | 17 U/L |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures | Alkaline Phosphatase (U/L)- Day 169 - 183 | 79.5 U/L |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)- Screening | 17 U/L |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)- Day 1 - 15 | 21 U/L |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)- Day 99 - 113 | 22 U/L |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)- Day 169 - 183 | 17 U/L |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)- Day 252 - 267 | 25 U/L |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)- Day 442 - 456 | 19 U/L |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures | AST (U/L)- Screening | 22 U/L |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures | AST (U/L)- Day 1 - 15 | 22 U/L |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures | AST (U/L)- Day 99 - 113 | 25 U/L |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures | AST (U/L)- Day 169 - 183 | 20 U/L |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures | Alkaline Phosphatase (U/L)- Screening | 71 U/L |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures | Alkaline Phosphatase (U/L)- Day 1 - 15 | 69 U/L |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures | Alkaline Phosphatase (U/L)- Day 99 - 113 | 72 U/L |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures | Alkaline Phosphatase (U/L)- Day 442 - 456 | 70 U/L |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures | AST (U/L)- Screening | 19 U/L |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)- Day 127 - 141 | 13 U/L |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)- Screening | 15.5 U/L |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures | Alkaline Phosphatase (U/L)- Screening | 52.5 U/L |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures | Alkaline Phosphatase (U/L)- Day 127 - 141 | 52 U/L |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures | Alkaline Phosphatase (U/L)- Day 1 - 15 | 54 U/L |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)- Day 1 - 15 | 13 U/L |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures | AST (U/L)- Day 1 - 15 | 18 U/L |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures | AST (U/L)- Day 127 - 141 | 17 U/L |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)- Day 1 - 15 | 13.5 U/L |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures | Alkaline Phosphatase (U/L)- Day 252 - 267 | 70.5 U/L |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures | AST (U/L)- Screening | 15.5 U/L |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures | Alkaline Phosphatase (U/L)- Day 1 - 15 | 60.5 U/L |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)- Screening | 13 U/L |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures | AST (U/L)- Day 252 - 267 | 19 U/L |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)- Day 252 - 267 | 18.5 U/L |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures | AST (U/L)- Day 1 - 15 | 19.5 U/L |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures | Alkaline Phosphatase (U/L)- Screening | 55.5 U/L |
| Group 6: Pre-treatment | Chemistry and Hematology Laboratory Measures | Alkaline Phosphatase (U/L)- Screening | 97 U/L |
| Group 6: Pre-treatment | Chemistry and Hematology Laboratory Measures | AST (U/L)- Screening | 32 U/L |
| Group 6: Pre-treatment | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)- Screening | 33 U/L |
Primary
Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin
Chemistry and Hematology Laboratory Measures - creatinine (g/dl), hemoglobin (g/dl)
Time frame: Measured through IV infusion at visits 1 (screening), 4 (day 1-15), 7 (day 57-71), 10 (day 99-113), 12 (day 127-141), 14 (day 169-183), 16 (day 252-267), and 18 (day 442-456) (visits depending on which group participants are in)
Population: Visit schedule is not the same for each treatment group. For visits not on the schedule, number analyzed is 0 and median/IQR is ---.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Creatinine (g/dL)- Day 57 - 71 | 0.00076 g/dl |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Hemoglobin (g/dL)- Day 57 - 71 | 14.1 g/dl |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Creatinine (g/dL)- Day 252 - 267 | 0.000715 g/dl |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Hemoglobin (g/dL)- Day 169 - 183 | 14 g/dl |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Hemoglobin (g/dL)- Day 127 - 141 | 13.7 g/dl |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Creatinine (g/dL)- Day 1 - 15 | 0.00076 g/dl |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Creatinine (g/dL)- Day 169 - 183 | 0.00073 g/dl |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Creatinine (g/dL)- Screening | 0.00073 g/dl |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Hemoglobin (g/dL)- Day 1 - 15 | 13.8 g/dl |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Creatinine (g/dL)- Day 127 - 141 | 0.00074 g/dl |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Hemoglobin (g/dL)- Screening | 14.5 g/dl |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Hemoglobin (g/dL)- Day 252 - 267 | 14.05 g/dl |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Hemoglobin (g/dL)- Day 169 - 183 | 13 g/dl |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Creatinine (g/dL)- Day 169 - 183 | 0.0008 g/dl |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Hemoglobin (g/dL)- Day 1 - 15 | 13.3 g/dl |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Hemoglobin (g/dL)- Screening | 14 g/dl |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Hemoglobin (g/dL)- Day 57 - 71 | 14 g/dl |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Hemoglobin (g/dL)- Day 127 - 141 | 13.25 g/dl |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Creatinine (g/dL)- Day 127 - 141 | 0.000735 g/dl |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Hemoglobin (g/dL)- Day 252 - 267 | 13.4 g/dl |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Creatinine (g/dL)- Screening | 0.00074 g/dl |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Creatinine (g/dL)- Day 252 - 267 | 0.00072 g/dl |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Creatinine (g/dL)- Day 1 - 15 | 0.00076 g/dl |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Creatinine (g/dL)- Day 57 - 71 | 0.00076 g/dl |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Hemoglobin (g/dL)- Screening | 13.7 g/dl |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Hemoglobin (g/dL)- Day 442 - 456 | 14.6 g/dl |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Creatinine (g/dL)- Day 442 - 456 | 0.00082 g/dl |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Creatinine (g/dL)- Day 169 - 183 | 0.000765 g/dl |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Creatinine (g/dL)- Screening | 0.00071 g/dl |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Creatinine (g/dL)- Day 99 - 113 | 0.00078 g/dl |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Creatinine (g/dL)- Day 1 - 15 | 0.00071 g/dl |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Hemoglobin (g/dL)- Day 99 - 113 | 14.6 g/dl |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Hemoglobin (g/dL)- Day 169 - 183 | 13.7 g/dl |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Hemoglobin (g/dL)- Day 1 - 15 | 13.7 g/dl |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Hemoglobin (g/dL)- Day 127 - 141 | 14.3 g/dl |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Creatinine (g/dL)- Screening | 0.00085 g/dl |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Creatinine (g/dL)- Day 127 - 141 | 0.00081 g/dl |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Hemoglobin (g/dL)- Screening | 14.75 g/dl |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Hemoglobin (g/dL)- Day 1 - 15 | 14 g/dl |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Creatinine (g/dL)- Day 1 - 15 | 0.0008 g/dl |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Hemoglobin (g/dL)- Day 252 - 267 | 14.25 g/dl |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Creatinine (g/dL)- Screening | 0.00074 g/dl |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Hemoglobin (g/dL)- Screening | 13.3 g/dl |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Hemoglobin (g/dL)- Day 1 - 15 | 12.95 g/dl |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Creatinine (g/dL)- Day 1 - 15 | 0.000735 g/dl |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Creatinine (g/dL)- Day 252 - 267 | 0.00077 g/dl |
| Group 6: Pre-treatment | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Hemoglobin (g/dL)- Screening | 14.9 g/dl |
| Group 6: Pre-treatment | Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin | Creatinine (g/dL)- Screening | 0.00086 g/dl |
Primary
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Chemistry and Hematology Laboratory Measures - lymphocyte count (1000/mm3), neutrophil count (1000/mm3), platelets (1000/mm3), white blood cells (WBC) (1000/mm3)
Time frame: Measured through IV infusion at visits 1 (screening), 4 (day 1-15), 7 (day 57-71), 10 (day 99-113), 12 (day 127-141), 14 (day 169-183), 16 (day 252-267), and 18 (day 442-456) (visits depending on which group participants are in)
Population: Visit schedule is not the same for each treatment group. For visits not on the schedule, number analyzed is 0 and median/IQR is ---.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Day 252 - 267 | 6.21 1000/mm3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000/cubic mm)- Screening | 3.709 1000/mm3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000/cubic mm)- Day 127 - 141 | 3.8025 1000/mm3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000/cubic mm)- Day 252 - 267 | 1.8045 1000/mm3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000/cubic mm)- Day 169 - 183 | 1.7685 1000/mm3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000/cubic mm)- Day 1 - 15 | 3.336 1000/mm3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000/cubic mm)- Screening | 2.033 1000/mm3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000/cubic mm)- Day 127 - 141 | 1.843 1000/mm3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000/cubic mm)- Day 57 - 71 | 3.3 1000/mm3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Day 252 - 267 | 253 1000/mm3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Day 169 - 183 | 249 1000/mm3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000/cubic mm)- Day 1 - 15 | 1.93 1000/mm3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Day 127 - 141 | 258 1000/mm3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000/cubic mm)- Day 57 - 71 | 1.7 1000/mm3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000/cubic mm)- Day 169 - 183 | 3.63 1000/mm3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Screening | 6.37 1000/mm3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Day 57 - 71 | 247 1000/mm3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Day 1 - 15 | 5.9 1000/mm3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Day 1 - 15 | 255 1000/mm3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Day 57 - 71 | 6.21 1000/mm3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000/cubic mm)- Day 252 - 267 | 4.0245 1000/mm3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Day 127 - 141 | 6.395 1000/mm3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Screening | 256 1000/mm3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Day 169 - 183 | 5.83 1000/mm3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Screening | 275 1000/mm3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Day 252 - 267 | 266.5 1000/mm3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000/cubic mm)- Day 57 - 71 | 2.27 1000/mm3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000/cubic mm)- Screening | 4.185 1000/mm3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000/cubic mm)- Day 252 - 267 | 3.599 1000/mm3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Day 57 - 71 | 7.26 1000/mm3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000/cubic mm)- Day 169 - 183 | 1.966 1000/mm3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Screening | 7.14 1000/mm3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000/cubic mm)- Day 169 - 183 | 3.14 1000/mm3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000/cubic mm)- Day 1 - 15 | 3.54 1000/mm3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Day 57 - 71 | 285 1000/mm3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000/cubic mm)- Day 127 - 141 | 2.09 1000/mm3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000/cubic mm)- Day 252 - 267 | 1.95 1000/mm3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Day 1 - 15 | 274 1000/mm3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000/cubic mm)- Screening | 2.198 1000/mm3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000/cubic mm)- Day 127 - 141 | 3.4375 1000/mm3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Day 169 - 183 | 6.2 1000/mm3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Day 169 - 183 | 261 1000/mm3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Day 1 - 15 | 5.86 1000/mm3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000/cubic mm)- Day 57 - 71 | 4 1000/mm3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000/cubic mm)- Day 1 - 15 | 1.872 1000/mm3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Day 252 - 267 | 6.92 1000/mm3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Day 127 - 141 | 294 1000/mm3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Day 127 - 141 | 6.475 1000/mm3 |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Day 442 - 456 | 269 1000/mm3 |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000/cubic mm)- Day 99 - 113 | 3.27 1000/mm3 |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000/cubic mm)- Day 169 - 183 | 3.775 1000/mm3 |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000/cubic mm)- Day 442 - 456 | 3.02 1000/mm3 |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000/cubic mm)- Screening | 2.255 1000/mm3 |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000/cubic mm)- Day 1 - 15 | 2.21 1000/mm3 |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000/cubic mm)- Day 99 - 113 | 1.743 1000/mm3 |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Screening | 8.31 1000/mm3 |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Day 1 - 15 | 6.53 1000/mm3 |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Day 99 - 113 | 5.5 1000/mm3 |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Day 169 - 183 | 6.5 1000/mm3 |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Day 442 - 456 | 5.67 1000/mm3 |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000/cubic mm)- Screening | 4.958 1000/mm3 |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000/cubic mm)- Day 1 - 15 | 3.853 1000/mm3 |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000/cubic mm)- Day 169 - 183 | 1.7765 1000/mm3 |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000/cubic mm)- Day 442 - 456 | 2.156 1000/mm3 |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Screening | 281 1000/mm3 |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Day 1 - 15 | 285 1000/mm3 |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Day 99 - 113 | 290 1000/mm3 |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Day 169 - 183 | 278 1000/mm3 |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000/cubic mm)- Day 127 - 141 | 3.26 1000/mm3 |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Day 1 - 15 | 258.5 1000/mm3 |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000/cubic mm)- Screening | 1.875 1000/mm3 |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Screening | 258 1000/mm3 |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Screening | 5.85 1000/mm3 |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Day 127 - 141 | 5.5 1000/mm3 |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000/cubic mm)- Screening | 3.494 1000/mm3 |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000/cubic mm)- Day 1 - 15 | 1.68 1000/mm3 |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Day 127 - 141 | 274 1000/mm3 |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000/cubic mm)- Day 1 - 15 | 3.124 1000/mm3 |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Day 1 - 15 | 5.2 1000/mm3 |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000/cubic mm)- Day 127 - 141 | 1.72 1000/mm3 |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000/cubic mm)- Screening | 2.161 1000/mm3 |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Day 252 - 267 | 6.45 1000/mm3 |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000/cubic mm)- Day 252 - 267 | 2.251 1000/mm3 |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Day 1 - 15 | 6.35 1000/mm3 |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Screening | 270.5 1000/mm3 |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000/cubic mm)- Day 252 - 267 | 3.301 1000/mm3 |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Day 1 - 15 | 278 1000/mm3 |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Screening | 6.45 1000/mm3 |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Day 252 - 267 | 259.5 1000/mm3 |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000/cubic mm)- Day 1 - 15 | 2.0345 1000/mm3 |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000/cubic mm)- Day 1 - 15 | 3.733 1000/mm3 |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000/cubic mm)- Screening | 3.4345 1000/mm3 |
| Group 6: Pre-treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Screening | 9.02 1000/mm3 |
| Group 6: Pre-treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000/cubic mm)- Screening | 6.747 1000/mm3 |
| Group 6: Pre-treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Screening | 334 1000/mm3 |
| Group 6: Pre-treatment | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000/cubic mm)- Screening | 1.741 1000/mm3 |
Primary
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels and total IgG levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the IgG-normalized VRC01/VRC01LS levels performed by dividing VRC01/LS levels (pg/mL) by the total IgG concentrations (ng/mL)
Time frame: Measured through 6 months after the last infusion
Population: Visit schedule is not the same for each treatment group. For visits not on the schedule, number analyzed is 0 and median/IQR is ---.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 2 | 0.06 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 17 | 0.03 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 16 | 0.21 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 15 | 1 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 14 | 7.29 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 2 | 0.04 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 17 | 0.09 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 16 | 0.11 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 15 | 0.57 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 14 | 6.11 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 12 | 2.45 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 9 | 0.85 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 7 | 4.31 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 5 | 1.35 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 4 | 6.57 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 2 | 0.04 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 17 | 0.01 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 16 | 0.17 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 15 | 1.47 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 14 | 5.54 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 12 | 2.88 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 9 | 1.03 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 7 | 5.08 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 5 | 1.88 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 4 | 5.27 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 2 | 0 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 17 | 0.07 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 17 | 2.12 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 16 | 0.33 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 16 | 0.29 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 15 | 0.62 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 15 | 0.32 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 14 | 3.85 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 14 | 1.14 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 12 | 0.9 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 12 | 0.89 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 9 | 0.9 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 9 | 0.28 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 7 | 2.81 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 7 | 1.15 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 5 | 0.78 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 5 | 0.39 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 4 | 2.6 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 4 | 2.54 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 2 | 0.2 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 2 | 0.15 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 17 | 0.02 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 17 | 0.1 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 16 | 0.07 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 16 | 0.32 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 15 | 1.07 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 15 | 2.1 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 14 | 10.97 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 14 | 9.59 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 2 | 0.02 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 2 | 0.01 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 17 | 0.06 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 16 | 0.17 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 15 | 0.95 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 14 | 7.02 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 17 | 0.06 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 2 | 0.02 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 14 | 14.6 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 15 | 3.12 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 16 | 0.47 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 17 | 0.06 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 2 | 0.04 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 2 | 0.02 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 14 | 9.81 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 14 | 17.89 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 15 | 1.92 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 15 | 4.34 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 16 | 0.4 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 16 | 0.44 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 17 | 0.02 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 17 | 0.01 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 2 | 0.23 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 2 | 0.09 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 4 | 7.02 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 4 | 4.51 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 5 | 1.97 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 5 | 1.56 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 7 | 7.63 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 7 | 6.46 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 9 | 2.55 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 9 | 2.62 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 12 | 2.38 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 12 | 1.91 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 14 | 4.81 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 14 | 7.18 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 15 | 1.02 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 15 | 1.43 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 16 | 0.77 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 16 | 0.44 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 17 | 0.1 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 17 | 0.1 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 2 | 0 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 4 | 13.2 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 5 | 5.18 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 7 | 12.66 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 9 | 5.17 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 12 | 9.72 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 14 | 14.45 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 15 | 3.87 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 16 | 0.39 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 17 | 0.01 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 2 | 0.05 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 4 | 15.26 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 5 | 5.06 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 7 | 16.27 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 9 | 4.78 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 12 | 9.43 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 14 | 11.51 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 15 | 2.05 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 16 | 1.08 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 17 | 0.05 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 2 | 0.03 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 14 | 17.29 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 15 | 2.67 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 16 | 0.56 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 14 | 0.14 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 5 | 7.07 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 12 | 0.66 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 4 | 25 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 4 | 26.33 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 5 | 6.38 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 9 | 0.48 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 12 | 0.15 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 9 | 1.28 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 12 | 0.14 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 5 | 2.81 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 12 | 0.2 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 14 | 0.07 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 4 | 14.7 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 9 | 0.71 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 5 | 6.55 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 14 | 0.06 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 12 | 0.33 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 1 | 0.01 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 7 | 3.75 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 4 | 25.6 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 5 | 7.53 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 9 | 0.99 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 12 | 0.52 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 14 | 0.26 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 1 | 0.15 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 7 | 2.47 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 14 | 0.23 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 9 | 0.18 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 7 | 1.23 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 4 | 20.07 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 1 | 0.49 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 14 | 0.2 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 5 | 6.22 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 4 | 13.07 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 9 | 1 pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 5 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 7 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 4 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 3 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 5 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 3 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 2 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 1 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 4 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 1 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 7 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 17 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 16 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 3 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 15 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 3 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 14 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 12 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 3 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 9 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 5 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 7 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 1 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 5 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 1 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 4 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 1 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 3 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 4 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 3 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 2 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 17 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 2 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 1 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 17 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 16 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 16 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 15 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 14 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 15 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 12 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 9 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 7 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 14 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 5 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 4 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 3 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 9 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 3 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 2 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 1 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 12 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 3 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 3 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 3 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 1 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 9 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 12 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 1 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 7 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 7 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 7 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 7 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 9 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 12 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 14 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 15 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 16 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 17 | — pg mAb/ng IgG |
Primary
IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels and total IgG levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the IgG-normalized VRC01/VRC01LS levels performed by dividing VRC01/LS levels (pg/mL) by the total IgG concentrations (ng/mL)
Time frame: Measured through 6 months after the last infusion
Population: Visit schedule is not the same for each treatment group. For visits not on the schedule, number analyzed is 0 and median/IQR is ---.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 7 | 4.26 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 14 | 6.55 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 12 | 3.07 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 7 | 5.75 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 16 | 0.08 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 12 | 1.94 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 9 | 0.9 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 4 | 6.28 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 9 | 1 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 17 | 0 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 16 | 0.09 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 4 | 6.8 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 2 | 0 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 15 | 0.84 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 5 | 1.54 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 2 | 0 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 15 | 0.78 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 5 | 1.44 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 17 | 0 pg mAb/ng IgG |
| Group 1: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 14 | 7.13 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 7 | 19.67 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 2 | 0 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 2 | 0 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 4 | 13.82 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 4 | 12.94 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 5 | 4 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 5 | 3.59 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 7 | 23.75 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 9 | 3.61 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 9 | 3.55 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 12 | 8.41 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 12 | 7.49 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 14 | 13.11 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 14 | 21.79 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 15 | 1.88 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 15 | 3.38 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 16 | 0.17 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 16 | 0.39 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 17 | 0.01 pg mAb/ng IgG |
| Group 2: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 17 | 0.01 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 4 | 17.02 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 5 | 5.48 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 3 | 0 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 14 | 0.06 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 5 | 7.09 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 9 | 0.79 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 3 | 0.01 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 9 | 0.41 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 7 | 1.62 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 4 | 22.1 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 12 | 0.15 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 7 | 2.31 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 12 | 0.13 pg mAb/ng IgG |
| Group 3: Vaccine | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 14 | 0.06 pg mAb/ng IgG |
| Unknown | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 1 | — pg mAb/ng IgG |
| Unknown | IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 1 | — pg mAb/ng IgG |
Primary
Number of Participants Reporting Adverse Events (AEs)
For participants reporting multiple AEs over the time frame, the maximum severity is counted
Time frame: Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | Number of Participants Reporting Adverse Events (AEs) | Mild | 5 Participants |
| Group 1: Vaccine | Number of Participants Reporting Adverse Events (AEs) | No AE reported | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Adverse Events (AEs) | Potentially life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Adverse Events (AEs) | Severe | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Adverse Events (AEs) | Moderate | 16 Participants |
| Group 2: Vaccine | Number of Participants Reporting Adverse Events (AEs) | Mild | 3 Participants |
| Group 2: Vaccine | Number of Participants Reporting Adverse Events (AEs) | Moderate | 11 Participants |
| Group 2: Vaccine | Number of Participants Reporting Adverse Events (AEs) | No AE reported | 5 Participants |
| Group 2: Vaccine | Number of Participants Reporting Adverse Events (AEs) | Severe | 4 Participants |
| Group 2: Vaccine | Number of Participants Reporting Adverse Events (AEs) | Potentially life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Adverse Events (AEs) | Severe | 1 Participants |
| Group 3: Vaccine | Number of Participants Reporting Adverse Events (AEs) | Moderate | 6 Participants |
| Group 3: Vaccine | Number of Participants Reporting Adverse Events (AEs) | Potentially life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Adverse Events (AEs) | No AE reported | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Adverse Events (AEs) | Mild | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Adverse Events (AEs) | Moderate | 5 Participants |
| Group 4: Vaccine | Number of Participants Reporting Adverse Events (AEs) | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Adverse Events (AEs) | No AE reported | 9 Participants |
| Group 4: Vaccine | Number of Participants Reporting Adverse Events (AEs) | Mild | 2 Participants |
| Group 4: Vaccine | Number of Participants Reporting Adverse Events (AEs) | Potentially life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Adverse Events (AEs) | Potentially life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Adverse Events (AEs) | Mild | 1 Participants |
| Group 5: Vaccine | Number of Participants Reporting Adverse Events (AEs) | Severe | 1 Participants |
| Group 5: Vaccine | Number of Participants Reporting Adverse Events (AEs) | Moderate | 1 Participants |
| Group 5: Vaccine | Number of Participants Reporting Adverse Events (AEs) | No AE reported | 7 Participants |
| Group 6: Pre-treatment | Number of Participants Reporting Adverse Events (AEs) | No AE reported | 0 Participants |
| Group 6: Pre-treatment | Number of Participants Reporting Adverse Events (AEs) | Mild | 1 Participants |
| Group 6: Pre-treatment | Number of Participants Reporting Adverse Events (AEs) | Moderate | 0 Participants |
| Group 6: Pre-treatment | Number of Participants Reporting Adverse Events (AEs) | Potentially life-threatening | 0 Participants |
| Group 6: Pre-treatment | Number of Participants Reporting Adverse Events (AEs) | Severe | 0 Participants |
Primary
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\] The maximum grade observed for each symptom over the time frame is presented.
Time frame: Measured through 3 days after each infusion at months 0, 2, 3, 4 or 6 (infusion visits depending on which group participants are in)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Moderate | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Mild | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | None | 22 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Moderate | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Mild | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | None | 19 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | None | 19 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | None | 22 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Mild | 4 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Mild | 4 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Mild | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | None | 18 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | None | 22 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Mild | 5 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Mild | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Mild | 7 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Mild | 5 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Moderate | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Mild | 2 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | None | 15 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | None | 21 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | None | 23 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | None | 18 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Mild | 2 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | None | 16 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Moderate | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | None | 21 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Mild | 6 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | None | 7 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Severe | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Mild | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Moderate | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | None | 7 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Mild | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Moderate | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Severe | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | None | 7 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Mild | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Moderate | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Severe | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | None | 7 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Mild | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Moderate | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Severe | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | None | 7 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Mild | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Moderate | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Severe | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | None | 7 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Mild | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Moderate | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Severe | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Mild | 3 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Mild | 1 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Mild | 3 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | None | 13 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | None | 13 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | None | 15 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | None | 16 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Mild | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Moderate | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Moderate | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | None | 16 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | None | 16 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Moderate | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Mild | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Moderate | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Moderate | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Mild | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Mild | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Mild | 1 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | None | 9 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | None | 10 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | None | 10 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Mild | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | None | 10 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Mild | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Mild | 1 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | None | 9 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Mild | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | None | 10 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema/Redness | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Moderate | 0 Participants |
Primary
Number of Participants Reporting Serious Adverse Events (SAEs)
For participants reporting multiple AEs over the time frame, the maximum severity is counted
Time frame: Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | Number of Participants Reporting Serious Adverse Events (SAEs) | SAE | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Serious Adverse Events (SAEs) | No SAE reported | 23 Participants |
| Group 2: Vaccine | Number of Participants Reporting Serious Adverse Events (SAEs) | SAE | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Serious Adverse Events (SAEs) | No SAE reported | 22 Participants |
| Group 3: Vaccine | Number of Participants Reporting Serious Adverse Events (SAEs) | SAE | 1 Participants |
| Group 3: Vaccine | Number of Participants Reporting Serious Adverse Events (SAEs) | No SAE reported | 6 Participants |
| Group 4: Vaccine | Number of Participants Reporting Serious Adverse Events (SAEs) | SAE | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Serious Adverse Events (SAEs) | No SAE reported | 16 Participants |
| Group 5: Vaccine | Number of Participants Reporting Serious Adverse Events (SAEs) | SAE | 1 Participants |
| Group 5: Vaccine | Number of Participants Reporting Serious Adverse Events (SAEs) | No SAE reported | 9 Participants |
| Group 6: Pre-treatment | Number of Participants Reporting Serious Adverse Events (SAEs) | SAE | 0 Participants |
| Group 6: Pre-treatment | Number of Participants Reporting Serious Adverse Events (SAEs) | No SAE reported | 1 Participants |
Primary
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\] The maximum grade observed for each symptom over the time frame is presented.
Time frame: Measured through 3 days after each infusion at months 0, 2, 3, 4 or 6 (infusion visits depending on which group participants are in)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 13 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 3 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 20 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 9 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 2 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 11 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 2 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 10 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Diarrhea | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Diarrhea | Moderate | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 14 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Diarrhea | Mild | 2 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Diarrhea | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Diarrhea | None | 20 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 21 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 21 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 2 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 2 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 21 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 22 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 22 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 7 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 18 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 3 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 2 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 19 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 4 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 17 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 4 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 2 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 19 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 4 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 23 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 22 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 22 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Diarrhea | None | 17 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Diarrhea | Mild | 6 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Diarrhea | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Diarrhea | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Diarrhea | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 14 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 7 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 2 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 22 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 2 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Diarrhea | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 1 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Diarrhea | Moderate | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 5 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Diarrhea | Severe | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 7 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 7 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Diarrhea | Mild | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Diarrhea | None | 7 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 1 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 1 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 7 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 1 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 3 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 6 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 7 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 3 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 5 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 7 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 16 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 12 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 1 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 16 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 1 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 16 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 15 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 15 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Diarrhea | None | 15 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Diarrhea | Mild | 1 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Diarrhea | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Diarrhea | Moderate | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 1 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 1 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Diarrhea | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 11 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 4 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 1 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 3 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 15 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 14 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 2 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Diarrhea | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 10 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 10 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 10 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 8 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 1 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 1 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 2 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 10 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 10 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Diarrhea | None | 10 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Diarrhea | Mild | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 10 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 9 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Diarrhea | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Diarrhea | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 9 Participants |
Primary
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Number of Participants with Chemistry and Hematology Laboratory Measures - Counts of Lab Grade \> 1 for alkaline phosphate (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC).
Time frame: Measured through IV infusion at visits 1 (screening), 4 (day 1-15), 7 (day 57-71), 10 (day 99-113), 12 (day 127-141), 14 (day 169-183), 16 (day 252-267), and 18 (day 442-456) (visits depending on which group participants are in)
Population: Visit schedule is not the same for each treatment group. For visits not on the schedule, number analyzed is 0.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 127 - 141 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- DayScreening | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 442 - 456 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 442 - 456 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- DayScreening | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 442 - 456 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 169 - 183 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 1 - 15 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 127 - 141 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 252 - 267 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- DayScreening | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 57 - 71 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 57 - 71 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 99 - 113 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 169 - 183 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 99 - 113 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- DayScreening | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 127 - 141 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 252 - 267 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 1 - 15 | 1 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 252 - 267 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 1 - 15 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 99 - 113 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 442 - 456 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 442 - 456 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 57 - 71 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- DayScreening | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 127 - 141 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 1 - 15 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 1 - 15 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 57 - 71 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 57 - 71 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- DayScreening | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 99 - 113 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 442 - 456 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 169 - 183 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- DayScreening | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 169 - 183 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 99 - 113 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 127 - 141 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- DayScreening | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 442 - 456 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 127 - 141 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 169 - 183 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 169 - 183 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 169 - 183 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 1 - 15 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 252 - 267 | 1 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 127 - 141 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 169 - 183 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 1 - 15 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 442 - 456 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 127 - 141 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- DayScreening | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 1 - 15 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 57 - 71 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 252 - 267 | 1 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 99 - 113 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 57 - 71 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 252 - 267 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 252 - 267 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 57 - 71 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 99 - 113 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 99 - 113 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 57 - 71 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 442 - 456 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 127 - 141 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 1 - 15 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 169 - 183 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 99 - 113 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 252 - 267 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 252 - 267 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 99 - 113 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- DayScreening | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 127 - 141 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 169 - 183 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 442 - 456 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 57 - 71 | 1 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 169 - 183 | 3 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 442 - 456 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 252 - 267 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 99 - 113 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- DayScreening | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 99 - 113 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 99 - 113 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 442 - 456 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 252 - 267 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- DayScreening | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 1 - 15 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 442 - 456 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 1 - 15 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 169 - 183 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 169 - 183 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 127 - 141 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 57 - 71 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- DayScreening | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 252 - 267 | 1 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 252 - 267 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 252 - 267 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 99 - 113 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 442 - 456 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 99 - 113 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 1 - 15 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 127 - 141 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 169 - 183 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 127 - 141 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- DayScreening | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 169 - 183 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 57 - 71 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 169 - 183 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- DayScreening | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 1 - 15 | 1 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 252 - 267 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 99 - 113 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 127 - 141 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 252 - 267 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 169 - 183 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 1 - 15 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 57 - 71 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 252 - 267 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 127 - 141 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 442 - 456 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 127 - 141 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 57 - 71 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 1 - 15 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 99 - 113 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- DayScreening | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 442 - 456 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 57 - 71 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 442 - 456 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 1 - 15 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 57 - 71 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 1 - 15 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- DayScreening | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 127 - 141 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 442 - 456 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 1 - 15 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 169 - 183 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 57 - 71 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 57 - 71 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- DayScreening | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 127 - 141 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 252 - 267 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 99 - 113 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 252 - 267 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 127 - 141 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 442 - 456 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 127 - 141 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 252 - 267 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 252 - 267 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 169 - 183 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 442 - 456 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 99 - 113 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 127 - 141 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- DayScreening | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 1 - 15 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 99 - 113 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 57 - 71 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 169 - 183 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 252 - 267 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 57 - 71 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 442 - 456 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 1 - 15 | 1 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- DayScreening | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 1 - 15 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- DayScreening | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- DayScreening | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 57 - 71 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 442 - 456 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 99 - 113 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 252 - 267 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 127 - 141 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 252 - 267 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 169 - 183 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 169 - 183 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 252 - 267 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 127 - 141 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 442 - 456 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 1 - 15 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- DayScreening | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 442 - 456 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 99 - 113 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 1 - 15 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 57 - 71 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 57 - 71 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 169 - 183 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 99 - 113 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 1 - 15 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 127 - 141 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 169 - 183 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 57 - 71 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- DayScreening | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 252 - 267 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 442 - 456 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 442 - 456 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 442 - 456 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- DayScreening | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 252 - 267 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 1 - 15 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 169 - 183 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 57 - 71 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 99 - 113 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 127 - 141 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 127 - 141 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 99 - 113 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 169 - 183 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 169 - 183 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 99 - 113 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 99 - 113 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 127 - 141 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 57 - 71 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- DayScreening | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 1 - 15 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 1 - 15 | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- DayScreening | 0 Participants |
| Group 3: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 57 - 71 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 1 - 15 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 57 - 71 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 169 - 183 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- DayScreening | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 1 - 15 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 57 - 71 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 99 - 113 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 127 - 141 | 1 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 169 - 183 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 252 - 267 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 442 - 456 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- DayScreening | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 1 - 15 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 57 - 71 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 99 - 113 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 127 - 141 | 1 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 169 - 183 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 252 - 267 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 442 - 456 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- DayScreening | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 1 - 15 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 57 - 71 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 99 - 113 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 127 - 141 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 169 - 183 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 252 - 267 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 442 - 456 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- DayScreening | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 57 - 71 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 99 - 113 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 127 - 141 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 169 - 183 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 252 - 267 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 442 - 456 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- DayScreening | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 1 - 15 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 99 - 113 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 127 - 141 | 1 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 252 - 267 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 442 - 456 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- DayScreening | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 1 - 15 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 57 - 71 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 99 - 113 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 127 - 141 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 169 - 183 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 252 - 267 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 442 - 456 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- DayScreening | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 1 - 15 | 1 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 57 - 71 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 99 - 113 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 127 - 141 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 169 - 183 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 252 - 267 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 442 - 456 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- DayScreening | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 1 - 15 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 57 - 71 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 99 - 113 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 127 - 141 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 169 - 183 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 252 - 267 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 442 - 456 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- DayScreening | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 1 - 15 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 57 - 71 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 99 - 113 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 127 - 141 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 169 - 183 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 252 - 267 | 0 Participants |
| Group 4: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 442 - 456 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 169 - 183 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 57 - 71 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 127 - 141 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- DayScreening | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 1 - 15 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- DayScreening | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 1 - 15 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 442 - 456 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 99 - 113 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 57 - 71 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 252 - 267 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 169 - 183 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 99 - 113 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 127 - 141 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 99 - 113 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 127 - 141 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 127 - 141 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 57 - 71 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 1 - 15 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 442 - 456 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 127 - 141 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- DayScreening | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 252 - 267 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 442 - 456 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 57 - 71 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 442 - 456 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 252 - 267 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 169 - 183 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- DayScreening | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 99 - 113 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 1 - 15 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 57 - 71 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 169 - 183 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 57 - 71 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 1 - 15 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- DayScreening | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 99 - 113 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 442 - 456 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 1 - 15 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 127 - 141 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 252 - 267 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 169 - 183 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 169 - 183 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 127 - 141 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- DayScreening | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 252 - 267 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 99 - 113 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 442 - 456 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 442 - 456 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 57 - 71 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 1 - 15 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 252 - 267 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- DayScreening | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- DayScreening | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 1 - 15 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 442 - 456 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 252 - 267 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 57 - 71 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 57 - 71 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 1 - 15 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 169 - 183 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 99 - 113 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- DayScreening | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 127 - 141 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 442 - 456 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 252 - 267 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 169 - 183 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 169 - 183 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 99 - 113 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 252 - 267 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 127 - 141 | 0 Participants |
| Group 5: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 99 - 113 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 127 - 141 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 442 - 456 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 57 - 71 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 99 - 113 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 1 - 15 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 442 - 456 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 252 - 267 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- DayScreening | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 252 - 267 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- DayScreening | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 127 - 141 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 99 - 113 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 169 - 183 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 1 - 15 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 442 - 456 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 127 - 141 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 252 - 267 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 252 - 267 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 169 - 183 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 57 - 71 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 57 - 71 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 169 - 183 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- DayScreening | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 57 - 71 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 169 - 183 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 99 - 113 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 127 - 141 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 99 - 113 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 57 - 71 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 99 - 113 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 1 - 15 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 127 - 141 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 252 - 267 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 1 - 15 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 99 - 113 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 127 - 141 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- Day 127 - 141 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 169 - 183 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 57 - 71 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000/cubic mm)- DayScreening | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 99 - 113 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 57 - 71 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 169 - 183 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 252 - 267 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 442 - 456 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 442 - 456 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 252 - 267 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 99 - 113 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- Day 1 - 15 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Day 442 - 456 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- DayScreening | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 169 - 183 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 169 - 183 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 1 - 15 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000/cubic mm)- Day 442 - 456 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- DayScreening | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 127 - 141 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 99 - 113 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- DayScreening | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 442 - 456 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000/cubic mm)- DayScreening | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 1 - 15 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 57 - 71 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 127 - 141 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Day 1 - 15 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000/cubic mm)- Day 442 - 456 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 252 - 267 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Day 57 - 71 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Day 252 - 267 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- DayScreening | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 1 - 15 | 0 Participants |
| Group 6: Pre-treatment | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Day 169 - 183 | 0 Participants |
Primary
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels and total protein levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the protein-normalized VRC01/VRC01LS levels performed by dividing VRC01/LS levels (pg/mL) by the total protein concentrations (ng/mL)
Time frame: Measured through 6 months after the last infusion
Population: Visit schedule is not the same for each treatment group. For visits not on the schedule, number analyzed is 0 and median/IQR is ---.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 2 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 17 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 16 | 0.01 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 15 | 0.04 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 14 | 0.21 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 2 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 17 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 16 | 0.01 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 15 | 0.06 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 14 | 0.29 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 12 | 0.28 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 9 | 0.04 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 7 | 0.21 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 5 | 0.03 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 4 | 0.29 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 2 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 17 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 16 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 15 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 14 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 12 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 9 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 7 | 0.01 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 5 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 4 | 0.01 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 2 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 17 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 17 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 16 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 16 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 15 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 15 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 14 | 0.01 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 14 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 12 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 12 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 9 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 9 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 7 | 0.01 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 7 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 5 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 5 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 4 | 0.01 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 4 | 0.01 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 2 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 2 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 17 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 17 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 16 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 16 | 0.01 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 15 | 0.02 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 15 | 0.03 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 14 | 0.1 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 14 | 0.13 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 2 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 2 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 17 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 16 | 0.01 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 15 | 0.05 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 14 | 0.3 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 17 | 0 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 2 | 0 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 14 | 0.87 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 15 | 0.16 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 16 | 0.03 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 17 | 0 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 2 | 0 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 2 | 0 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 14 | 0.17 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 14 | 0.23 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 15 | 0.04 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 15 | 0.06 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 16 | 0.01 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 16 | 0.01 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 17 | 0 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 17 | 0 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 2 | 0 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 2 | 0 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 4 | 0 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 4 | 0.03 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 5 | 0.01 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 5 | 0.01 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 7 | 0.01 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 7 | 0.03 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 9 | 0.01 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 9 | 0 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 12 | 0 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 12 | 0.01 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 14 | 0.01 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 14 | 0.01 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 15 | 0 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 15 | 0 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 16 | 0 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 16 | 0 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 17 | 0 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 17 | 0 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 2 | 0 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 4 | 0.02 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 5 | 0.01 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 7 | 0.02 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 9 | 0.01 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 12 | 0.02 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 14 | 0.02 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 15 | 0.01 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 16 | 0 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 17 | 0 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 2 | 0 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 4 | 0.68 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 5 | 0.16 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 7 | 0.8 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 9 | 0.23 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 12 | 0.54 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 14 | 0.49 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 15 | 0.07 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 16 | 0.03 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 17 | 0 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 2 | 0 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 14 | 0.76 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 15 | 0.11 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 16 | 0.02 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 14 | 0 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 5 | 0.01 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 12 | 0.01 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 4 | 0.86 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 4 | 0.41 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 5 | 0.08 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 9 | 0.01 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 12 | 0 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 9 | 0.04 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 12 | 0 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 5 | 0 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 12 | 0 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 14 | 0 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 4 | 0.96 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 9 | 0.03 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 5 | 0.25 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 14 | 0 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 12 | 0.01 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 1 | 0 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 7 | 0.07 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 4 | 1.12 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 5 | 0.24 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 9 | 0.04 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 12 | 0.02 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 14 | 0 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 1 | 0 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 7 | 0 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 14 | 0.01 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 9 | 0 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 7 | 0 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 4 | 0.02 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 1 | 0.01 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 14 | 0.01 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 5 | 0.19 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 4 | 0.02 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 9 | 0 pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 5 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 7 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 4 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 3 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 7 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 3 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 2 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 1 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 5 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 1 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 7 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 17 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 16 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 4 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 15 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 3 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 14 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 12 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 3 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 9 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 5 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 7 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 3 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 5 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 1 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 4 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 1 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 3 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 4 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 3 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 2 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 1 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 2 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 1 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 17 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 17 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 16 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 15 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 14 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 16 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 12 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 9 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 7 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 15 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 5 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 4 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 3 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 14 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 3 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 2 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 1 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 12 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 3 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 3 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 3 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 1 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 9 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 12 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 1 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 9 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 7 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 7 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 7 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 9 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 12 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 14 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 15 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 16 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 17 | — pg mAb/ng total protein |
Primary
Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels and total protein levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the protein-normalized VRC01/VRC01LS levels performed by dividing VRC01/LS levels (pg/mL) by the total protein concentrations (ng/mL)
Time frame: Measured through 6 months after the last infusion
Population: Visit schedule is not the same for each treatment group. For visits not on the schedule, number analyzed is 0 and median/IQR is ---.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 7 | 0.66 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 14 | 0.9 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 12 | 0.39 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 7 | 0.67 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 16 | 0.01 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 12 | 0.35 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 9 | 0.16 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 4 | 0.87 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 9 | 0.18 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 17 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 16 | 0.02 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 4 | 0.78 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 2 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 15 | 0.15 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 5 | 0.21 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 2 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 15 | 0.1 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 5 | 0.21 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 17 | 0 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 14 | 0.84 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 7 | 2.34 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 2 | 0 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 2 | 0 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 4 | 2.5 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 4 | 2.04 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 5 | 0.6 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 5 | 0.65 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 7 | 3.66 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 9 | 0.68 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 9 | 0.6 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 12 | 1.22 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 12 | 1.22 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 14 | 2.07 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 14 | 2.59 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 15 | 0.32 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 15 | 0.69 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 16 | 0.03 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 16 | 0.07 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 17 | 0 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 17 | 0 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 4 | 2.39 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 5 | 0.63 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 3 | 0 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 14 | 0.01 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 5 | 0.88 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 9 | 0.1 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 3 | 0 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 9 | 0.06 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 7 | 0.19 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 4 | 2.77 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 12 | 0.02 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 7 | 0.33 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 12 | 0.02 pg mAb/ng total protein |
| Group 3: Vaccine | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 14 | 0.01 pg mAb/ng total protein |
| Unknown | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 1 | — pg mAb/ng total protein |
| Unknown | Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 1 | — pg mAb/ng total protein |
Primary
Rates of Participant Discontinuation
Tabulated by reason for discontinuation and treatment arm
Time frame: Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | Rates of Participant Discontinuation | Terminated to donate bone marrow | 0 Participants |
| Group 1: Vaccine | Rates of Participant Discontinuation | Coenrolled with an investigational agent | 1 Participants |
| Group 1: Vaccine | Rates of Participant Discontinuation | Refused study product administration | 1 Participants |
| Group 1: Vaccine | Rates of Participant Discontinuation | Did not discontinue SPA | 19 Participants |
| Group 1: Vaccine | Rates of Participant Discontinuation | Unable to contact participant for visits | 1 Participants |
| Group 1: Vaccine | Rates of Participant Discontinuation | Clinical event (not reacto, HIV, death) | 1 Participants |
| Group 2: Vaccine | Rates of Participant Discontinuation | Refused study product administration | 0 Participants |
| Group 2: Vaccine | Rates of Participant Discontinuation | Coenrolled with an investigational agent | 0 Participants |
| Group 2: Vaccine | Rates of Participant Discontinuation | Terminated to donate bone marrow | 1 Participants |
| Group 2: Vaccine | Rates of Participant Discontinuation | Clinical event (not reacto, HIV, death) | 0 Participants |
| Group 2: Vaccine | Rates of Participant Discontinuation | Unable to contact participant for visits | 0 Participants |
| Group 2: Vaccine | Rates of Participant Discontinuation | Did not discontinue SPA | 22 Participants |
| Group 3: Vaccine | Rates of Participant Discontinuation | Refused study product administration | 0 Participants |
| Group 3: Vaccine | Rates of Participant Discontinuation | Did not discontinue SPA | 6 Participants |
| Group 3: Vaccine | Rates of Participant Discontinuation | Clinical event (not reacto, HIV, death) | 1 Participants |
| Group 3: Vaccine | Rates of Participant Discontinuation | Unable to contact participant for visits | 0 Participants |
| Group 3: Vaccine | Rates of Participant Discontinuation | Coenrolled with an investigational agent | 0 Participants |
| Group 3: Vaccine | Rates of Participant Discontinuation | Terminated to donate bone marrow | 0 Participants |
| Group 4: Vaccine | Rates of Participant Discontinuation | Coenrolled with an investigational agent | 0 Participants |
| Group 4: Vaccine | Rates of Participant Discontinuation | Refused study product administration | 0 Participants |
| Group 4: Vaccine | Rates of Participant Discontinuation | Did not discontinue SPA | 16 Participants |
| Group 4: Vaccine | Rates of Participant Discontinuation | Terminated to donate bone marrow | 0 Participants |
| Group 4: Vaccine | Rates of Participant Discontinuation | Unable to contact participant for visits | 0 Participants |
| Group 4: Vaccine | Rates of Participant Discontinuation | Clinical event (not reacto, HIV, death) | 0 Participants |
| Group 5: Vaccine | Rates of Participant Discontinuation | Did not discontinue SPA | 10 Participants |
| Group 5: Vaccine | Rates of Participant Discontinuation | Clinical event (not reacto, HIV, death) | 0 Participants |
| Group 5: Vaccine | Rates of Participant Discontinuation | Unable to contact participant for visits | 0 Participants |
| Group 5: Vaccine | Rates of Participant Discontinuation | Refused study product administration | 0 Participants |
| Group 5: Vaccine | Rates of Participant Discontinuation | Coenrolled with an investigational agent | 0 Participants |
| Group 5: Vaccine | Rates of Participant Discontinuation | Terminated to donate bone marrow | 0 Participants |
Primary
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the estimated concentration of VRC01/VRC01LS.
Time frame: Measured through 6 months after the last infusion
Population: Visit schedule is not the same for each treatment group. For visits not on the schedule, number analyzed is 0 and median/IQR is ---.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 2 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 17 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 16 | 0.01 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 15 | 0.05 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 14 | 0.13 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 2 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 17 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 16 | 0.01 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 15 | 0.09 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 14 | 0.33 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 12 | 0.43 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 9 | 0.04 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 7 | 0.29 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 5 | 0.04 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 4 | 0.28 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 2 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 17 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 16 | 0.01 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 15 | 0.04 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 14 | 0.13 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 12 | 0.12 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 9 | 0.04 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 7 | 0.14 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 5 | 0.05 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 4 | 0.15 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 2 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 17 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 17 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 16 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 16 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 15 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 15 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 14 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 14 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 12 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 12 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 9 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 9 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 7 | 0.01 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 7 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 5 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 5 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 4 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 4 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 2 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 2 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 17 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 17 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 16 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 16 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 15 | 0.02 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 15 | 0.02 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 14 | 0.06 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 14 | 0.1 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 2 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 2 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 17 | 0 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 16 | 0.01 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 15 | 0.06 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 14 | 0.28 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 17 | 0.01 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 2 | 0 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 14 | 0.91 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 15 | 0.17 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 16 | 0.02 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 17 | 0 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 2 | 0 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 2 | 0 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 14 | 0.16 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 14 | 0.23 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 15 | 0.04 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 15 | 0.06 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 16 | 0.01 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 16 | 0.01 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 17 | 0 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 17 | 0 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 2 | 0 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 2 | 0 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 4 | 0 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 4 | 0.02 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 5 | 0 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 5 | 0 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 7 | 0.01 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 7 | 0.02 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 9 | 0.01 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 9 | 0 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 12 | 0 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 12 | 0 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 14 | 0 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 14 | 0 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 15 | 0 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 15 | 0 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 16 | 0 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 16 | 0 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 17 | 0 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 17 | 0 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 2 | 0 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 4 | 0.43 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 5 | 0.14 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 7 | 0.46 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 9 | 0.17 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 12 | 0.32 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 14 | 0.42 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 15 | 0.12 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 16 | 0.01 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 17 | 0 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 2 | 0 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 4 | 0.67 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 5 | 0.16 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 7 | 0.97 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 9 | 0.24 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 12 | 0.71 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 14 | 0.6 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 15 | 0.09 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 16 | 0.04 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 17 | 0 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 2 | 0 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 14 | 0.87 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 15 | 0.11 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 16 | 0.03 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 14 | 0.01 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 5 | 0.16 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 12 | 0.01 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 4 | 0.7 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 4 | 0.33 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 5 | 0.09 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 9 | 0.01 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 12 | 0 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 9 | 0.06 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 12 | 0 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 5 | 0 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 12 | 0 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 14 | 0 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 4 | 0.93 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 9 | 0.03 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 5 | 0.29 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 14 | 0 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 12 | 0.01 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 1 | 0 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 7 | 0.08 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 4 | 0.9 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 5 | 0.26 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 9 | 0.03 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 12 | 0.01 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 14 | 0 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 1 | 0 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 7 | 0.05 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 14 | 0.01 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 9 | 0 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 7 | 0 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 4 | 0.49 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 1 | 0.02 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 14 | 0.01 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 5 | 0.2 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 4 | 0.01 µg/mL |
| Group 3: Vaccine | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 9 | 0.02 µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 5 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 7 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 4 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 3 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 7 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 3 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 2 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 1 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 5 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 1 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 7 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 17 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 16 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 4 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 15 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 3 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 14 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 12 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 3 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 9 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 5 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 7 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 3 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 5 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 1 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 4 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 1 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 3 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 4 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Female-Visit 3 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 2 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 1 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 2 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Softcup Fluid-Male-Visit 1 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 17 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 17 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 16 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 15 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 14 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 16 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 12 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 9 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 7 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 15 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 5 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 4 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Male-Visit 3 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 14 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 3 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 2 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Semen-Female-Visit 1 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 12 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Male-Visit 3 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 3 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 3 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Secretions-Female-Visit 1 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Male-Visit 9 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 12 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Cervical Biopsy Lysate-Female-Visit 1 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Female-Visit 9 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Rectal Biopsy Lysate-Male-Visit 7 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Female-Visit 7 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 7 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 9 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 12 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 14 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 15 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 16 | — µg/mL |
| Unknown | Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) | Vaginal Biopsy Lysate-Male-Visit 17 | — µg/mL |
Primary
Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the estimated concentration of VRC01/VRC01LS.
Time frame: Measured through 6 months after the last infusion
Population: Visit schedule is not the same for each treatment group. For visits not on the schedule, number analyzed is 0 and median/IQR is ---.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 7 | 50.95 µg/mL |
| Group 1: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 14 | 81.92 µg/mL |
| Group 1: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 12 | 36.48 µg/mL |
| Group 1: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 7 | 62.08 µg/mL |
| Group 1: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 16 | 1.12 µg/mL |
| Group 1: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 12 | 29.11 µg/mL |
| Group 1: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 9 | 13.48 µg/mL |
| Group 1: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 4 | 72.42 µg/mL |
| Group 1: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 9 | 14.84 µg/mL |
| Group 1: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 17 | 0.03 µg/mL |
| Group 1: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 16 | 1.25 µg/mL |
| Group 1: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 4 | 64.83 µg/mL |
| Group 1: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 2 | 0.02 µg/mL |
| Group 1: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 15 | 11.5 µg/mL |
| Group 1: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 5 | 19.77 µg/mL |
| Group 1: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 2 | 0.02 µg/mL |
| Group 1: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 15 | 9.6 µg/mL |
| Group 1: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 5 | 19.57 µg/mL |
| Group 1: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 17 | 0.02 µg/mL |
| Group 1: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 14 | 72.35 µg/mL |
| Group 2: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 7 | 202.99 µg/mL |
| Group 2: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 2 | 0.02 µg/mL |
| Group 2: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 2 | 0.02 µg/mL |
| Group 2: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 4 | 215.65 µg/mL |
| Group 2: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 4 | 185.55 µg/mL |
| Group 2: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 5 | 49.27 µg/mL |
| Group 2: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 5 | 54.09 µg/mL |
| Group 2: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 7 | 274.67 µg/mL |
| Group 2: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 9 | 54.76 µg/mL |
| Group 2: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 9 | 49.05 µg/mL |
| Group 2: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 12 | 112.28 µg/mL |
| Group 2: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 12 | 104.97 µg/mL |
| Group 2: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 14 | 174.79 µg/mL |
| Group 2: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 14 | 228.43 µg/mL |
| Group 2: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 15 | 26.85 µg/mL |
| Group 2: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 15 | 62.81 µg/mL |
| Group 2: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 16 | 3.03 µg/mL |
| Group 2: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 16 | 6.85 µg/mL |
| Group 2: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 17 | 0.11 µg/mL |
| Group 2: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 17 | 0.15 µg/mL |
| Group 3: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 4 | 194.99 µg/mL |
| Group 3: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 5 | 60.48 µg/mL |
| Group 3: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 3 | 0.05 µg/mL |
| Group 3: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 14 | 0.67 µg/mL |
| Group 3: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 5 | 72.31 µg/mL |
| Group 3: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 9 | 8.51 µg/mL |
| Group 3: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 3 | 0.05 µg/mL |
| Group 3: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 9 | 5.81 µg/mL |
| Group 3: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 7 | 20.99 µg/mL |
| Group 3: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 4 | 240.46 µg/mL |
| Group 3: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 12 | 1.65 µg/mL |
| Group 3: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 7 | 29.72 µg/mL |
| Group 3: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 12 | 1.71 µg/mL |
| Group 3: Vaccine | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 14 | 0.66 µg/mL |
| Unknown | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Male-Visit 1 | — µg/mL |
| Unknown | Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) | Serum-Female-Visit 1 | — µg/mL |
Secondary
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Magnitudes of ex vivo HIV-1 infection were measured by the tissue luminescence assay (TLA). Susceptibility to viral infection in the ex vivo challenge assay is summarized by the area under the viral infectivity curve (AUC) based on log-transformed RLU values between 3-21 days of culture, indicated as AUCday3-21.
Time frame: Cervical biopsies collected at visits 2 and 14; Rectal biopsies collected at visits 2, 14, 15, 16, 17, 18, 19 (19 not apply for Du422.1); Vaginal biopsies collected at visits 2 and 14, 15, 16, 17. RLU measured every 3 days, during culture days 3-21.
Population: Visit schedule is not the same for each treatment group. For visits not on the schedule, number analyzed is 0 and median/IQR is ---.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Du422.1-visit 15 | 141.14 Log(RLU)*Day |
| Group 1: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Du422.1-visit 14 | 145.48 Log(RLU)*Day |
| Group 1: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Bal26-visit 2 | 142.83 Log(RLU)*Day |
| Group 1: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Vaginal Biopsy-Bal26-visit 17 | 131.37 Log(RLU)*Day |
| Group 1: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Du422.1-visit 2 | 141.44 Log(RLU)*Day |
| Group 1: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Bal26-visit 14 | 93.17 Log(RLU)*Day |
| Group 1: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Vaginal Biopsy-Bal26-visit 15 | 94.41 Log(RLU)*Day |
| Group 1: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Bal26-visit 17 | 138.8 Log(RLU)*Day |
| Group 1: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Bal26-visit 15 | 136.16 Log(RLU)*Day |
| Group 1: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-1086-visit 14 | 147.95 Log(RLU)*Day |
| Group 1: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Bal26-visit 16 | 136.69 Log(RLU)*Day |
| Group 1: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Cervical Biopsy-Bal26-visit 14 | 81.74 Log(RLU)*Day |
| Group 1: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Vaginal Biopsy-Bal26-visit 14 | 80.78 Log(RLU)*Day |
| Group 1: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-1086-visit 15 | 150.66 Log(RLU)*Day |
| Group 1: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Cervical Biopsy-Bal26-visit 2 | 134.61 Log(RLU)*Day |
| Group 1: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Vaginal Biopsy-Bal26-visit 2 | 128.69 Log(RLU)*Day |
| Group 1: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-1086-visit 16 | 147.24 Log(RLU)*Day |
| Group 1: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Vaginal Biopsy-Bal26-visit 16 | 128.28 Log(RLU)*Day |
| Group 1: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Du422.1-visit 17 | 145.72 Log(RLU)*Day |
| Group 1: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-1086-visit 17 | 147.56 Log(RLU)*Day |
| Group 1: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-1086-visit 2 | 149.47 Log(RLU)*Day |
| Group 1: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Du422.1-visit 16 | 143.53 Log(RLU)*Day |
| Group 2: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-1086-visit 2 | 151.28 Log(RLU)*Day |
| Group 2: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Cervical Biopsy-Bal26-visit 2 | 128.69 Log(RLU)*Day |
| Group 2: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Cervical Biopsy-Bal26-visit 14 | 80.03 Log(RLU)*Day |
| Group 2: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Vaginal Biopsy-Bal26-visit 17 | 137.49 Log(RLU)*Day |
| Group 2: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-1086-visit 14 | 147.69 Log(RLU)*Day |
| Group 2: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-1086-visit 15 | 148.86 Log(RLU)*Day |
| Group 2: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-1086-visit 16 | 145.82 Log(RLU)*Day |
| Group 2: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-1086-visit 17 | 148.37 Log(RLU)*Day |
| Group 2: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Bal26-visit 2 | 139.99 Log(RLU)*Day |
| Group 2: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Bal26-visit 14 | 97.41 Log(RLU)*Day |
| Group 2: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Bal26-visit 15 | 117.51 Log(RLU)*Day |
| Group 2: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Bal26-visit 16 | 135.71 Log(RLU)*Day |
| Group 2: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Bal26-visit 17 | 140.59 Log(RLU)*Day |
| Group 2: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Du422.1-visit 2 | 142.74 Log(RLU)*Day |
| Group 2: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Du422.1-visit 14 | 138.99 Log(RLU)*Day |
| Group 2: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Du422.1-visit 15 | 139.5 Log(RLU)*Day |
| Group 2: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Du422.1-visit 16 | 142 Log(RLU)*Day |
| Group 2: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Du422.1-visit 17 | 139.58 Log(RLU)*Day |
| Group 2: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Vaginal Biopsy-Bal26-visit 2 | 130.33 Log(RLU)*Day |
| Group 2: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Vaginal Biopsy-Bal26-visit 14 | 82.89 Log(RLU)*Day |
| Group 2: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Vaginal Biopsy-Bal26-visit 15 | 89.85 Log(RLU)*Day |
| Group 2: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Vaginal Biopsy-Bal26-visit 16 | 104.97 Log(RLU)*Day |
| Group 3: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-1086-visit 19 | 148.87 Log(RLU)*Day |
| Group 3: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Vaginal Biopsy-Bal26-visit 14 | 80.88 Log(RLU)*Day |
| Group 3: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Du422.1-visit 14 | 143.46 Log(RLU)*Day |
| Group 3: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-1086-visit 18 | 139.29 Log(RLU)*Day |
| Group 3: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-1086-visit 2 | 145.97 Log(RLU)*Day |
| Group 3: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Du422.1-visit 15 | 145.45 Log(RLU)*Day |
| Group 3: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-1086-visit 17 | 148.82 Log(RLU)*Day |
| Group 3: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Vaginal Biopsy-Bal26-visit 16 | 82.76 Log(RLU)*Day |
| Group 3: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Du422.1-visit 16 | 144.16 Log(RLU)*Day |
| Group 3: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-1086-visit 16 | 153.31 Log(RLU)*Day |
| Group 3: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Vaginal Biopsy-Bal26-visit 15 | 82.26 Log(RLU)*Day |
| Group 3: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Du422.1-visit 17 | 150.64 Log(RLU)*Day |
| Group 3: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Du422.1-visit 18 | 130.75 Log(RLU)*Day |
| Group 3: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-1086-visit 15 | 145.42 Log(RLU)*Day |
| Group 3: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Cervical Biopsy-Bal26-visit 14 | 82.33 Log(RLU)*Day |
| Group 3: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Bal26-visit 15 | 89.36 Log(RLU)*Day |
| Group 3: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Vaginal Biopsy-Bal26-visit 2 | 116.62 Log(RLU)*Day |
| Group 3: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Bal26-visit 16 | 92.33 Log(RLU)*Day |
| Group 3: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Bal26-visit 14 | 90.31 Log(RLU)*Day |
| Group 3: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-1086-visit 14 | 152.22 Log(RLU)*Day |
| Group 3: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Bal26-visit 17 | 129.17 Log(RLU)*Day |
| Group 3: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Bal26-visit 18 | 115.21 Log(RLU)*Day |
| Group 3: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Bal26-visit 19 | 106.05 Log(RLU)*Day |
| Group 3: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Bal26-visit 2 | 140.62 Log(RLU)*Day |
| Group 3: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Cervical Biopsy-Bal26-visit 2 | 125.66 Log(RLU)*Day |
| Group 3: Vaccine | Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) | Rectal Biopsy-Du422.1-visit 2 | 151.14 Log(RLU)*Day |