HIV Infections
Conditions
Brief summary
The purpose of this study is to evaluate the safety and pharmacokinetics of a human monoclonal antibody (VRC07-523LS) in the sera and mucosae of healthy, HIV-uninfected adults.
Detailed description
This study will evaluate the safety and pharmacokinetics of a human monoclonal antibody (VRC07-523LS) in the sera and mucosae of healthy, HIV-uninfected adults. Participants will be randomly assigned to one of two groups. Participants in Group 1 will receive 10 mg/kg of VRC07-523LS at Weeks 0, 16, and 32. Participants in Group 2 will receive 30 mg/kg of VRC07-523LS at Weeks 0, 16, and 32. Study visits will occur at Weeks 0, 2, 16, 18, 32, 34, and 48. Visits may include physical examinations; blood and urine collection; rectal, cervicovaginal, and seminal secretion collection; cervical, rectal, and vaginal biopsy collection; HIV testing; risk reduction counseling; and questionnaires. Study staff will contact participants at Week 50 for follow-up safety monitoring.
Interventions
BIOLOGICALVRC07-523LS
Administered by intravenous (IV) infusion
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 * 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 and completes a questionnaire prior to first study product administration 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 required protocol clinic 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 and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit. See the study protocol for US Low risk guidelines. Laboratory Inclusion Values Hemogram/Complete blood count (CBC) * Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were assigned female sex at birth, greater than or equal to 13.0 g/dL for volunteers who were assigned male sex at birth. For transgender participants who have been on hormone therapy for more than 6 consecutive months, determine hemoglobin eligibility based on the gender with which they identify (ie, a transgender female who has been on feminizing hormone therapy for more than 6 consecutive months should be assessed for eligibility using the hemoglobin parameters for persons assigned female sex at birth). * White blood cell (WBC) count equal to 2,500 to 12,000 cells/mm\^3 * WBC 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) less than 1.25 times the institutional upper limit of normal and creatinine less than or equal to institutional upper limits of normal. Virology * Negative HIV-1 and -2 blood test: US volunteers must have a negative US Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA). * Negative Hepatitis B surface antigen (HBsAg) * Negative anti-Hepatitis C virus (anti-HCV) antibodies, or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive Urine * Normal urine: * Negative or trace urine protein Reproductive Status * Volunteers who were assigned female sex at birth: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to biopsy collection and/or study product administration. * Reproductive status: A volunteer who was assigned female sex at birth must: * Agree to use effective contraception 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 128 Protocol Safety Review Team (PSRT) * Successful vasectomy in any partner assigned male sex at birth (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); * Tubal ligation * Or be sexually abstinent until at least 4 months following the last study product administration. * Volunteers who were assigned female sex at birth 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 assigned female sex at birth: 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 at several timepoints * Willing to abstain from sexual intercourse for the required period after each biopsy collection
Exclusion criteria
General * Weight greater than 115 kg * Blood products received within 120 days before first study product administration unless eligibility for earlier enrollment is determined by the HVTN 128 PSRT * Investigational research agents received within 30 days before first study product administration * 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 study * Pregnant or breastfeeding 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 128 PSRT will determine eligibility on a case-by-case basis. * Previous receipt of humanized or human monoclonal antibodies (mAbs), whether licensed or investigational; the HVTN 128 PSRT will determine eligibility on a case-by-case basis. * Previous receipt of monoclonal antibodies against HIV Immune System * Immunosuppressive medications received within 30 days before first infusion (Not exclusionary: \[1\] corticosteroid nasal spray; \[2\] inhaled corticosteroids; \[3\] topical corticosteroids for mild, uncomplicated dermatitis; or \[4\] a single course of oral/parenteral prednisone or equivalent at doses less than or equal to 20 mg/day and length of therapy less than 14 days) * Serious adverse reactions to VRC07-523LS formulation components (sucrose, histidine, and sorbitol; see study protocol for more information), including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. * Immunoglobulin received within 90 days before first infusion unless eligibility for earlier enrollment is determined by the HVTN 128 PSRT * Autoimmune disease (Not excluded from participation: Volunteer with mild, stable and uncomplicated autoimmune disease that does not require immunosuppressive medication and that, in the judgment of the site investigator, is likely not subject to exacerbation and likely not to complicate Solicited and Unsolicited AE assessments) * Immunodeficiency Clinically significant medical conditions * 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 inability to establish venous access, * 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 (eg, chronic urticaria or recent infusion with evidence of residual inflammation) for which signs or symptoms could be confused with reactions to the study product, or * Any condition specifically listed among the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Measured at Visits 2, 4, 5, 6, 7, 8, 9 (Weeks -2, 2, 16, 18, 32, 34, 48). | Pharmacokinetic - Binding Antibody Multiplex Assay (PK-BAMA) was used to measure levels of passively infused VRC07-523LS broadly neutralizing monoclonal antibody in participant sera using 5C9 anti-idiotype antibody (anti-ID). Outcome measure is the protein-normalized VRC07-523LS levels performed by dividing VRC07-523LS levels (pg/mL) by the total protein (ng/mL). |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Measured through 3 days after each infusion at weeks 0, 16 and 32 | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 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 weeks 0, 16 and 32 | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented |
| Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L | Measured during screening, visit 4(day 14), 6 (day 126) and 8 (day 238) | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. |
| Chemistry and Hematology Laboratory Measures- Hemoglobin and Creatinine (g/dl) | Measured during screening, Day 14, 126, 238 | For each local laboratory measure-Hemoglobin and Creatinine (g/dl), summary statistics were presented by treatment group and time point for the overall population. |
| Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Measured during screening, Day 14, 126, 238 | For each local laboratory measure lymphocyte count, neutrophil count, platelets, white blood cells (WBC) in 1000/ cubic mm summary statistics were presented by treatment group and time point |
| Chemistry and Hematology Laboratory Measures | Measured during screening, Day 14, 126, 238 | Counts of lab grade \>1 for ALT, creatine, hemoglobin, lymphocyte count, neutrophil, platelets, white blood cells |
| Number of Participants Reporting Adverse Events (AEs) | Enrollment through week 48 | Participants Max severity reported per participant over visit. |
| Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Enrollment through last scheduled dose at week 32 | The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm |
| Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Measured at Visits 2, 4, 5, 6, 7, 8, 9 (Weeks -2, 2, 16, 18, 32, 34, 48) in secretion samples (semen, cervicovaginal, and rectal) and at Visits 2, 4, 8, 9 (Weeks -2, 2, 34, 48) in biopsy samples (rectal, cervical, and vaginal). | Pharmacokinetic - Single Molecule Counting (PK-SMC) assay were used to measure passively infused VRC07-523LS broadly neutralizing monoclonal antibody in participant mucosa (secretions and biopsies) using 5C9 anti-idiotype antibody (anti-ID). Outcome measure is the concentration of VRC07-523LS. |
| IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Measured at Visits 2, 4, 5, 6, 7, 8, 9 (Weeks -2, 2, 16, 18, 32, 34, 48) in secretion samples (semen, cervicovaginal, and rectal) and at Visits 2, 4, 8, 9 (Weeks -2, 2, 34, 48) in biopsy samples (rectal, cervical, and vaginal). | Pharmacokinetic - Single Molecule Counting (PK-SMC) assay were used to measure passively infused VRC07-523LS broadly neutralizing monoclonal antibody in participant mucosa (secretions and biopsies) using 5C9 anti-idiotype antibody (anti-ID). Outcome measure is the IgG-normalized VRC07-523LS levels performed by dividing VRC07-523LS levels (pg/mL) by the total IgG (ng/mL). |
| Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Measured at Visits 2, 4, 5, 6, 7, 8, 9 (Weeks -2, 2, 16, 18, 32, 34, 48) in secretion samples (semen, cervicovaginal, and rectal) and at Visits 2, 4, 8, 9 (Weeks -2, 2, 34, 48) in biopsy samples (rectal, cervical, and vaginal). | Pharmacokinetic - Single Molecule Counting (PK-SMC) assay were used to measure passively infused VRC07-523LS broadly neutralizing monoclonal antibody in participant mucosa (secretions and biopsies) using 5C9 anti-idiotype antibody (anti-ID). Outcome measure is the protein-normalized VRC07-523LS levels performed by dividing VRC07-523LS levels (pg/mL) by the total protein (ng/mL). |
| Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Measured at Visits 2, 4, 5, 6, 7, 8, 9 (Weeks -2, 2, 16, 18, 32, 34, 48). | Pharmacokinetic - Binding Antibody Multiplex Assay (PK-BAMA) was used to measure levels of passively infused VRC07-523LS broadly neutralizing monoclonal antibody in participant sera using 5C9 anti-IDiotype antibody (anti-ID). Outcome measure is the concentration of VRC07-523LS. |
| IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Measured at Visits 2, 4, 5, 6, 7, 8, 9 (Weeks -2, 2, 16, 18, 32, 34, 48). | Pharmacokinetic - Binding Antibody Multiplex Assay (PK-BAMA) was used to measure levels of passively infused VRC07-523LS broadly neutralizing monoclonal antibody in participant sera using 5C9 anti-IDiotype antibody (anti-ID). Outcome measure is the IgG-normalized VRC07-523LS levels performed by dividing VRC07-523LS levels (pg/mL) by the average reference values for total IgG concentrations in serum in the USA (11,650,000 ng/mL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Concentration of ADA in Each Group Measured at Multiple Timepoints From Baseline Through the Final Study Visit | Measured at Visits 2, 3, 5, 7, and 9 (Weeks -2, 0, 16, 32, 48). However, Tier 3 ADA titers are only assessed and reported at Visits 2 and 3 (Weeks -2 and 0) for the subset of participants who tested positive for ADA Tiers 1 and 2. | Anti-drug dependent antibodies were measured by an ADA assay from specimens obtained from all participants. Tier 3 titers are only available for those participants who had positive for ADA Tiers 1 and 2. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Vaccine VRC07-523LS (VRC-HIVMAB075-00-AB) 10 mg/kg to be administered IV at weeks 0, 16, and 32 | 11 |
| Group 2: Vaccine VRC07-523LS (VRC-HIVMAB075-00-AB) 30 mg/kg to be administered IV at weeks 0, 16, and 32 | 13 |
| Group 3: Pre-treatment Biopsy collected but was not randomized to any treatment group | 4 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | Not Randomized | 0 | 0 | 4 |
| Overall Study | Participant unable to adhere to visit | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Group 2: Vaccine | Group 1: Vaccine | Group 3: Pre-treatment |
|---|---|---|---|---|
| Age, Continuous | 26 years | 26 years | 28 years | 22 years |
| Age, Customized 18 - 20 years | 5 Participants | 3 Participants | 0 Participants | 2 Participants |
| Age, Customized 21 - 30 years | 14 Participants | 6 Participants | 6 Participants | 2 Participants |
| Age, Customized 31 - 40 years | 5 Participants | 1 Participants | 4 Participants | 0 Participants |
| Age, Customized 41 - 50 years | 4 Participants | 3 Participants | 1 Participants | 0 Participants |
| Age, Customized Above 50 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Less than 18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 0 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 13 Participants | 9 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 8 Participants | 10 Participants | 3 Participants |
| Region of Enrollment USA | 28 Participants | 13 Participants | 11 Participants | 4 Participants |
| Sex: Female, Male Female | 13 Participants | 6 Participants | 6 Participants | 1 Participants |
| Sex: Female, Male Male | 15 Participants | 7 Participants | 5 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 13 | 0 / 4 |
| other Total, other adverse events | 10 / 11 | 12 / 13 | 0 / 4 |
| serious Total, serious adverse events | 0 / 11 | 0 / 13 | 0 / 4 |
Outcome results
Primary
Chemistry and Hematology Laboratory Measures
Counts of lab grade \>1 for ALT, creatine, hemoglobin, lymphocyte count, neutrophil, platelets, white blood cells
Time frame: Measured during screening, Day 14, 126, 238
Population: Samples were missing for follow-up visits due to miss visits or discontinuing study product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells/cubic mm)-Day 126 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells/cubic mm)-Day 126 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells/cubic mm)-Day 238 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | Hemoglobin (g/dL)-Day 14 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | Platelets (1000 cells/cubic mm)- Screening | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells/cubic mm)-Day 238 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | Platelets (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | WBC (1000 cells/cubic mm)-Day 238 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | Platelets (1000 cells/cubic mm)-Day 126 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | Hemoglobin (g/dL)- Screening | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | Platelets (1000 cells/cubic mm)-Day 238 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | WBC (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)- Screening | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | Hemoglobin (g/dL)-Day 126 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)-Day 14 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells/cubic mm)- Screening | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)-Day 126 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | Hemoglobin (g/dL)-Day 238 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)-Day 238 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | WBC (1000 cells/cubic mm)- Screening | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | Creatinine (g/dL)- Screening | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells/cubic mm)- Screening | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | Creatinine (g/dL)-Day 14 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | Creatinine (g/dL)-Day 126 | 1 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | Creatinine (g/dL)-Day 238 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures | WBC (1000 cells/cubic mm)-Day 126 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | Creatinine (g/dL)-Day 238 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | WBC (1000 cells/cubic mm)- Screening | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | WBC (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | WBC (1000 cells/cubic mm)-Day 126 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | WBC (1000 cells/cubic mm)-Day 238 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells/cubic mm)- Screening | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells/cubic mm)-Day 126 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | Neutrophils (1000 cells/cubic mm)-Day 238 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | Hemoglobin (g/dL)-Day 14 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | Hemoglobin (g/dL)-Day 126 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | Hemoglobin (g/dL)-Day 238 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells/cubic mm)- Screening | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells/cubic mm)-Day 126 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | Lymphocytes (1000 cells/cubic mm)-Day 238 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | Platelets (1000 cells/cubic mm)- Screening | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | Platelets (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | Platelets (1000 cells/cubic mm)-Day 126 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | Platelets (1000 cells/cubic mm)-Day 238 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)- Screening | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)-Day 14 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)-Day 126 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | ALT (SGPT) (U/L)-Day 238 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | Creatinine (g/dL)- Screening | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | Creatinine (g/dL)-Day 14 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | Creatinine (g/dL)-Day 126 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures | Hemoglobin (g/dL)- Screening | 0 Participants |
Primary
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time frame: Measured during screening, visit 4(day 14), 6 (day 126) and 8 (day 238)
Population: Samples were missing for follow-up visits due to miss visits or discontinuing study product.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L | ALT (SGPT) (U/L)- Screening | 19.0 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L | ALT (SGPT) (U/L)-Day 14 | 14.0 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L | ALT (SGPT) (U/L)-Day 126 | 22.0 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L | ALT (SGPT) (U/L)-Day 238 | 16.0 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L | ALT (SGPT) (U/L)-Day 238 | 14.0 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L | ALT (SGPT) (U/L)- Screening | 16.0 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L | ALT (SGPT) (U/L)-Day 126 | 17.0 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L | ALT (SGPT) (U/L)-Day 14 | 16.0 U/L |
Primary
Chemistry and Hematology Laboratory Measures- Hemoglobin and Creatinine (g/dl)
For each local laboratory measure-Hemoglobin and Creatinine (g/dl), summary statistics were presented by treatment group and time point for the overall population.
Time frame: Measured during screening, Day 14, 126, 238
Population: Samples were missing for follow-up visits due to miss visits or discontinuing study product.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures- Hemoglobin and Creatinine (g/dl) | Hemoglobin (g/dL)- Screening | 14.3 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures- Hemoglobin and Creatinine (g/dl) | Hemoglobin (g/dL)-Day 14 | 13.4 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures- Hemoglobin and Creatinine (g/dl) | Hemoglobin (g/dL)-Day 126 | 13.9 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures- Hemoglobin and Creatinine (g/dl) | Hemoglobin (g/dL)-Day 238 | 13.9 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures- Hemoglobin and Creatinine (g/dl) | Creatinine (g/dL)- Screening | .00076 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures- Hemoglobin and Creatinine (g/dl) | Creatinine (g/dL)-Day 14 | .00082 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures- Hemoglobin and Creatinine (g/dl) | Creatinine (g/dL)-Day 126 | .00077 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures- Hemoglobin and Creatinine (g/dl) | Creatinine (g/dL)-Day 238 | .00070 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures- Hemoglobin and Creatinine (g/dl) | Creatinine (g/dL)-Day 238 | .00085 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures- Hemoglobin and Creatinine (g/dl) | Hemoglobin (g/dL)- Screening | 13.9 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures- Hemoglobin and Creatinine (g/dl) | Creatinine (g/dL)- Screening | .00078 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures- Hemoglobin and Creatinine (g/dl) | Hemoglobin (g/dL)-Day 14 | 13.2 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures- Hemoglobin and Creatinine (g/dl) | Creatinine (g/dL)-Day 126 | .00081 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures- Hemoglobin and Creatinine (g/dl) | Hemoglobin (g/dL)-Day 126 | 14.0 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures- Hemoglobin and Creatinine (g/dl) | Creatinine (g/dL)-Day 14 | .00081 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures- Hemoglobin and Creatinine (g/dl) | Hemoglobin (g/dL)-Day 238 | 13.2 g/dL |
Primary
Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
For each local laboratory measure lymphocyte count, neutrophil count, platelets, white blood cells (WBC) in 1000/ cubic mm summary statistics were presented by treatment group and time point
Time frame: Measured during screening, Day 14, 126, 238
Population: Samples were missing for follow-up visits due to miss visits or discontinuing study product.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Screening | 8.03 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)-Day 14 | 6.22 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)-Day 126 | 7.63 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)-Day 238 | 8.02 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000 cells/cubic mm)- Screening | 4.74 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000 cells/cubic mm)-Day 14 | 3.65 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000 cells/cubic mm)-Day 126 | 4.98 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000 cells/cubic mm)-Day 238 | 4.75 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000 cells/cubic mm)- Screening | 2.30 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000 cells/cubic mm)-Day 14 | 1.91 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000 cells/cubic mm)-Day 126 | 1.72 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000 cells/cubic mm)-Day 238 | 2.04 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Screening | 260 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)-Day 14 | 243 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)-Day 126 | 247 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)-Day 238 | 239 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)-Day 238 | 264 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Screening | 7.12 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000 cells/cubic mm)- Screening | 2.28 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)-Day 14 | 7.12 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Screening | 249 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)-Day 126 | 5.55 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000 cells/cubic mm)-Day 14 | 1.82 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)-Day 238 | 5.22 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)-Day 126 | 253 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000 cells/cubic mm)- Screening | 3.45 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000 cells/cubic mm)-Day 126 | 1.71 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000 cells/cubic mm)-Day 14 | 3.90 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)-Day 14 | 225 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000 cells/cubic mm)-Day 126 | 3.19 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Lymphocytes (1000 cells/cubic mm)-Day 238 | 1.64 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) | Neutrophils (1000 cells/cubic mm)-Day 238 | 3.10 1000 cells/cubic mm |
Primary
IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Pharmacokinetic - Single Molecule Counting (PK-SMC) assay were used to measure passively infused VRC07-523LS broadly neutralizing monoclonal antibody in participant mucosa (secretions and biopsies) using 5C9 anti-idiotype antibody (anti-ID). Outcome measure is the IgG-normalized VRC07-523LS levels performed by dividing VRC07-523LS levels (pg/mL) by the total IgG (ng/mL).
Time frame: Measured at Visits 2, 4, 5, 6, 7, 8, 9 (Weeks -2, 2, 16, 18, 32, 34, 48) in secretion samples (semen, cervicovaginal, and rectal) and at Visits 2, 4, 8, 9 (Weeks -2, 2, 34, 48) in biopsy samples (rectal, cervical, and vaginal).
Population: Overall Number of Participants Analyzed represents the total number of infused participants in each group. Within each group, data are presented separately by sex, so the Number Analyzed per Row reflects the number of participants within each sex subgroup who contributed data for a specific timepoint or measure. Subgroup counts may be smaller than the overall number due to this stratification and the application of assay-specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 6 | 3.62 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Cervical Biopsy-Female-Visit 8 | 5.52 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 7 | 5.8 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Male-Visit 9 | 2.34 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 8 | 0.6 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Female-Visit 4 | 9.8 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 9 | 2.18 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 2 | 1.1 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 2 | 0.022 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Cervical Biopsy-Female-Visit 4 | 3.92 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 4 | 9.08 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 4 | 0.96 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 5 | 1.62 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Female-Visit 8 | 12.41 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 6 | 16.09 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 5 | 2.26 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 7 | 2.44 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 6 | 1.43 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 8 | 14.07 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Cervical Biopsy-Female-Visit 9 | 0.84 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 9 | 2.76 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 7 | 2.22 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 2 | 0.0068 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Female-Visit 9 | 1.02 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 4 | 3.74 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 8 | 2.79 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 5 | 0.71 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Male-Visit 2 | 0.05 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 6 | 6.8 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 9 | 1.89 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 7 | 1.6 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Cervical Biopsy-Female-Visit 2 | 0.062 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 8 | 7.15 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 2 | 1.86 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 9 | 0.88 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Male-Visit 4 | 8.35 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Vaginal Biopsy-Female-Visit 2 | 0.059 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 4 | 4.29 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Vaginal Biopsy-Female-Visit 4 | 4.85 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Female-Visit 2 | 0.085 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Vaginal Biopsy-Female-Visit 8 | 7.41 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 5 | 4.43 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Vaginal Biopsy-Female-Visit 9 | 1.29 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Male-Visit 8 | 16.05 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Vaginal Biopsy-Female-Visit 9 | 3.01 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 5 | 3.22 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Cervical Biopsy-Female-Visit 2 | 0.047 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Cervical Biopsy-Female-Visit 4 | 8.28 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Cervical Biopsy-Female-Visit 8 | 11.56 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Cervical Biopsy-Female-Visit 9 | 2.18 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Female-Visit 2 | 0.09 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Female-Visit 4 | 37.18 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Female-Visit 8 | 44.02 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Male-Visit 2 | 0.07 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Male-Visit 4 | 23.4 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Male-Visit 8 | 41.92 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Male-Visit 9 | 4.22 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 2 | 4.39 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 4 | 7.05 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 6 | 4.08 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 7 | 2.77 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 8 | 2.01 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 9 | 1.51 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 2 | 0.66 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 4 | 0.92 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 5 | 1.07 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 6 | 2.38 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 7 | 0.63 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 8 | 2.56 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 9 | 2.58 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 2 | 0.03 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 4 | 27.43 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 5 | 3.57 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 6 | 26.85 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 7 | 2.71 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 8 | 28.18 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 9 | 2.95 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 2 | 0.009 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 4 | 14.74 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 5 | 2.75 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 6 | 15.66 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 7 | 1.73 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 8 | 18.05 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 9 | 1.38 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Vaginal Biopsy-Female-Visit 2 | 0.23 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Vaginal Biopsy-Female-Visit 4 | 14.49 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Vaginal Biopsy-Female-Visit 8 | 11.41 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Female-Visit 9 | 5.46 pg mAb/ng total IgG |
Primary
IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Pharmacokinetic - Binding Antibody Multiplex Assay (PK-BAMA) was used to measure levels of passively infused VRC07-523LS broadly neutralizing monoclonal antibody in participant sera using 5C9 anti-IDiotype antibody (anti-ID). Outcome measure is the IgG-normalized VRC07-523LS levels performed by dividing VRC07-523LS levels (pg/mL) by the average reference values for total IgG concentrations in serum in the USA (11,650,000 ng/mL).
Time frame: Measured at Visits 2, 4, 5, 6, 7, 8, 9 (Weeks -2, 2, 16, 18, 32, 34, 48).
Population: Overall Number of Participants Analyzed represents the total number of infused participants in each group. Within each group, data are presented separately by sex, so the Number Analyzed per Row reflects the number of participants within each sex subgroup who contributed data for a specific timepoint or measure. Subgroup counts may be smaller than the overall number due to this stratification and the application of assay-specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 2 | 0.002 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 4 | 8.61 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 5 | 1.65 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 6 | 10.59 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 7 | 1.93 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 8 | 11.67 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 9 | 1.69 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 2 | 0.002 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 4 | 8.19 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 5 | 1.43 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 6 | 11.18 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 7 | 2.05 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 8 | 11.36 pg mAb/ng total IgG |
| Group 1: Vaccine | IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 9 | 2.18 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 6 | 27.92 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 2 | 0.002 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 2 | 0.002 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 4 | 18.9 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 8 | 29.06 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 5 | 3.8 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 4 | 23.33 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 6 | 21.39 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 7 | 3.87 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 7 | 2.63 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 5 | 3.99 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 8 | 23.26 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 9 | 3.47 pg mAb/ng total IgG |
| Group 2: Vaccine | IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 9 | 3.75 pg mAb/ng total IgG |
Primary
Number of Participants Reporting Adverse Events (AEs)
Participants Max severity reported per participant over visit.
Time frame: Enrollment through week 48
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | Number of Participants Reporting Adverse Events (AEs) | Moderate | 9 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 | 0 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) | Mild | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Adverse Events (AEs) | No AE reported | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Adverse Events (AEs) | Mild | 4 Participants |
| Group 2: Vaccine | Number of Participants Reporting Adverse Events (AEs) | Moderate | 6 Participants |
| Group 2: Vaccine | Number of Participants Reporting Adverse Events (AEs) | Severe | 2 Participants |
| Group 2: Vaccine | Number of Participants Reporting Adverse Events (AEs) | Potentially life-threatening | 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, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented.
Time frame: Measured through 3 days after each infusion at weeks 0, 16 and 32
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | None | 11 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | None | 10 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | Mild | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Mild | 6 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | Mild | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | 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 | Induration | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | None | 10 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | None | 5 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Mild | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Moderate | 0 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 | Erythema and/or Induration | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | Potentially Life-threatening | 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 | Pain and/or Tenderness | Moderate | 0 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 | Mild | 3 Participants |
| Group 2: 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 | Pain and/or Tenderness | Severe | 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 | Erythema | None | 12 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | Mild | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | None | 12 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | Mild | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | None | 11 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 | Erythema and/or Induration | Moderate | 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 | Pain and/or Tenderness | None | 10 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, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented
Time frame: Measured through 3 days after each infusion at weeks 0, 16 and 32
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | None | 11 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 | Non-exertional dyspnea | Mild | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 8 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Moderate | 0 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 | Non-exertional dyspnea | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 3 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 9 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | None | 11 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 | Urticaria | Mild | 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 | Urticaria | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 5 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | 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 | Urticaria | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 3 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | None | 10 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 | Non-exertional tachycardia | Mild | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 3 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Severe | 0 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 | Non-exertional tachycardia | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 10 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | None | 11 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 | Generalized Pruritus | Mild | 0 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 | Generalized Pruritus | Moderate | 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 | Generalized Pruritus | 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 | Generalized Pruritus | Potentially Life-threatening | 0 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 | Unexplained diaphoresis | None | 10 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 | Unexplained diaphoresis | Mild | 1 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 | Unexplained diaphoresis | Moderate | 0 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 | Unexplained diaphoresis | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 6 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | None | 8 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 1 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 | Max. Systemic Symptoms | Mild | 5 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Mild | 3 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 5 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 5 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 | Facial flushing | 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 | Malaise and/or fatigue | Mild | 6 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 10 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 1 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 | Temperature | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | 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 | Myalgia | Potentially Life-threatening | 0 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 | Malaise and/or fatigue | None | 3 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 4 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 5 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 3 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 1 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 | 8 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 3 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 1 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 | 6 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 5 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 | 10 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 3 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 | Nausea | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 7 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 3 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 2 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 | 11 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 | Arthralgia | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 1 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 | Facial flushing | None | 12 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Mild | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | None | 12 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Mild | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | None | 13 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Mild | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | None | 13 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Mild | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | None | 12 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Mild | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Moderate | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | None | 13 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Mild | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 2 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 | Max. Systemic Symptoms | Severe | 2 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 | Temperature | None | 11 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 2 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
Primary
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm
Time frame: Enrollment through last scheduled dose at week 32
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Clinical event (not reacto, HIV, death) | 0 Participants |
| Group 1: Vaccine | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Subject unable to attend clinic visits | 1 Participants |
| Group 1: Vaccine | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Did not discontinue SPA | 10 Participants |
| Group 2: Vaccine | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Clinical event (not reacto, HIV, death) | 2 Participants |
| Group 2: Vaccine | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Subject unable to attend clinic visits | 0 Participants |
| Group 2: Vaccine | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Did not discontinue SPA | 11 Participants |
Primary
Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Pharmacokinetic - Single Molecule Counting (PK-SMC) assay were used to measure passively infused VRC07-523LS broadly neutralizing monoclonal antibody in participant mucosa (secretions and biopsies) using 5C9 anti-idiotype antibody (anti-ID). Outcome measure is the protein-normalized VRC07-523LS levels performed by dividing VRC07-523LS levels (pg/mL) by the total protein (ng/mL).
Time frame: Measured at Visits 2, 4, 5, 6, 7, 8, 9 (Weeks -2, 2, 16, 18, 32, 34, 48) in secretion samples (semen, cervicovaginal, and rectal) and at Visits 2, 4, 8, 9 (Weeks -2, 2, 34, 48) in biopsy samples (rectal, cervical, and vaginal).
Population: Overall Number of Participants Analyzed represents the total number of infused participants in each group. Within each group, data are presented separately by sex, so the Number Analyzed per Row reflects the number of participants within each sex subgroup who contributed data for a specific timepoint or measure. Subgroup counts may be smaller than the overall number due to this stratification and the application of assay-specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 7 | 0.0028 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 4 | 0.02 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 6 | 0.0039 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 5 | 0.0028 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Cervical Biopsy-Female-Visit 2 | 0.0024 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Male-Visit 4 | 0.14 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Cervical Biopsy-Female-Visit 4 | 0.12 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 8 | 0.0037 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Cervical Biopsy-Female-Visit 8 | 0.16 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Cervical Biopsy-Female-Visit 9 | 0.054 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Female-Visit 8 | 0.17 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Female-Visit 2 | 0.0014 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 9 | 0.0027 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Female-Visit 4 | 0.14 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Male-Visit 8 | 0.21 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 6 | 0.025 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 2 | 0.0039 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 7 | 0.0034 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 9 | 0.0032 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 8 | 0.02 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 4 | 0.0032 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 9 | 0.005 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Male-Visit 9 | 0.027 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 2 | 0.00043 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 4 | 0.16 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 5 | 0.0045 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 5 | 0.017 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Female-Visit 9 | 0.014 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 6 | 0.22 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 6 | 0.004 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 7 | 0.047 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 2 | 0.0024 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 8 | 0.18 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 7 | 0.0035 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 9 | 0.021 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 5 | 0.002 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Vaginal Biopsy-Female-Visit 2 | 0.0016 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 8 | 0.004 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Vaginal Biopsy-Female-Visit 4 | 0.14 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 4 | 0.0025 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Vaginal Biopsy-Female-Visit 8 | 0.17 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Male-Visit 2 | 0.00095 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Vaginal Biopsy-Female-Visit 9 | 0.04 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 2 | 0.000044 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 2 | 0.000048 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 6 | 0.0035 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 5 | 0.0082 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Female-Visit 4 | 0.49 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Female-Visit 8 | 0.58 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Female-Visit 9 | 0.079 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Male-Visit 2 | 0.00092 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Male-Visit 4 | 0.25 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Male-Visit 8 | 0.6 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Male-Visit 9 | 0.047 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 2 | 0.0026 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 4 | 0.003 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 5 | 0.0024 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 7 | 0.0029 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 8 | 0.0026 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 9 | 0.0031 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 2 | 0.003 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 4 | 0.0027 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 5 | 0.0029 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 6 | 0.0025 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 7 | 0.0038 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 8 | 0.0043 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 9 | 0.0034 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Cervical Biopsy-Female-Visit 8 | 0.36 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 4 | 0.04 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Cervical Biopsy-Female-Visit 2 | 0.0018 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Cervical Biopsy-Female-Visit 4 | 0.32 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Cervical Biopsy-Female-Visit 9 | 0.086 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Female-Visit 2 | 0.0011 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 2 | 0.00025 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 6 | 0.058 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 7 | 0.0078 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 8 | 0.056 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 9 | 0.0091 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 4 | 0.32 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 5 | 0.051 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 6 | 0.36 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 7 | 0.1 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 8 | 0.32 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 9 | 0.011 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Vaginal Biopsy-Female-Visit 2 | 0.003 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Vaginal Biopsy-Female-Visit 4 | 0.34 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Vaginal Biopsy-Female-Visit 8 | 0.26 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Vaginal Biopsy-Female-Visit 9 | 0.036 pg mAb/ng total protein |
Primary
Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Pharmacokinetic - Binding Antibody Multiplex Assay (PK-BAMA) was used to measure levels of passively infused VRC07-523LS broadly neutralizing monoclonal antibody in participant sera using 5C9 anti-idiotype antibody (anti-ID). Outcome measure is the protein-normalized VRC07-523LS levels performed by dividing VRC07-523LS levels (pg/mL) by the total protein (ng/mL).
Time frame: Measured at Visits 2, 4, 5, 6, 7, 8, 9 (Weeks -2, 2, 16, 18, 32, 34, 48).
Population: Overall Number of Participants Analyzed represents the total number of infused participants in each group. Within each group, data are presented separately by sex, so the Number Analyzed per Row reflects the number of participants within each sex subgroup who contributed data for a specific timepoint or measure. Subgroup counts may be smaller than the overall number due to this stratification and the application of assay-specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 2 | 0.00022 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 4 | 0.97 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 5 | 0.19 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 6 | 1.25 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 7 | 0.22 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 8 | 1.3 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 9 | 0.2 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 2 | 0.00025 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 4 | 1 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 5 | 0.19 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 6 | 1.33 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 7 | 0.24 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 8 | 1.46 pg mAb/ng total protein |
| Group 1: Vaccine | Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 9 | 0.25 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 6 | 3.08 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 2 | 0.00026 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 2 | 0.00023 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 4 | 2.32 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 8 | 3.08 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 5 | 0.45 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 4 | 2.74 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 6 | 2.56 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 7 | 0.45 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 7 | 0.35 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 5 | 0.49 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 8 | 3 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 9 | 0.35 pg mAb/ng total protein |
| Group 2: Vaccine | Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 9 | 0.49 pg mAb/ng total protein |
Primary
Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints
Pharmacokinetic - Single Molecule Counting (PK-SMC) assay were used to measure passively infused VRC07-523LS broadly neutralizing monoclonal antibody in participant mucosa (secretions and biopsies) using 5C9 anti-idiotype antibody (anti-ID). Outcome measure is the concentration of VRC07-523LS.
Time frame: Measured at Visits 2, 4, 5, 6, 7, 8, 9 (Weeks -2, 2, 16, 18, 32, 34, 48) in secretion samples (semen, cervicovaginal, and rectal) and at Visits 2, 4, 8, 9 (Weeks -2, 2, 34, 48) in biopsy samples (rectal, cervical, and vaginal).
Population: Overall Number of Participants Analyzed represents the total number of infused participants in each group. Within each group, data are presented separately by sex, so the Number Analyzed per Row reflects the number of participants within each sex subgroup who contributed data for a specific timepoint or measure. Subgroup counts may be smaller than the overall number due to this stratification and the application of assay-specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 6 | 1153.16 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Female-Visit 8 | 182851.1 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 7 | 1153.16 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 2 | 1153.16 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 8 | 1153.16 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Cervical Biopsy-Female-Visit 8 | 57049.38 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 9 | 1153.16 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 4 | 1153.16 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 2 | 461.26 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Female-Visit 9 | 18611.77 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 4 | 214747.1 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 5 | 1153.16 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 5 | 34446.39 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Female-Visit 2 | 1153.16 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 6 | 317137.1 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 6 | 1153.16 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 7 | 48960.51 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Male-Visit 2 | 1153.16 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 8 | 265248.3 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 7 | 1153.16 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 9 | 60255.85 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Cervical Biopsy-Female-Visit 4 | 70184.27 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 2 | 1153.16 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 8 | 1153.16 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 4 | 1310855 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Male-Visit 4 | 134874.1 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 5 | 201939.7 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 9 | 1153.16 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 6 | 4357902 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Female-Visit 4 | 202976.8 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 7 | 1025192 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 2 | 1153.16 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 8 | 2861361 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Male-Visit 8 | 284185.5 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 9 | 531608.8 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 4 | 1153.16 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Vaginal Biopsy-Female-Visit 2 | 1153.16 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Cervical Biopsy-Female-Visit 9 | 32941.43 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Vaginal Biopsy-Female-Visit 4 | 130086.2 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 5 | 1153.16 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Vaginal Biopsy-Female-Visit 8 | 105012 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Male-Visit 9 | 34940.14 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Vaginal Biopsy-Female-Visit 9 | 30650.35 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Cervical Biopsy-Female-Visit 2 | 1153.16 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Vaginal Biopsy-Female-Visit 9 | 24562.42 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Cervical Biopsy-Female-Visit 2 | 1153.16 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Cervical Biopsy-Female-Visit 4 | 178305 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Cervical Biopsy-Female-Visit 8 | 175382.4 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Cervical Biopsy-Female-Visit 9 | 53680.14 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Female-Visit 2 | 1153.16 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Female-Visit 4 | 568748 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Female-Visit 8 | 715593.4 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Female-Visit 9 | 80218.02 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Male-Visit 2 | 1153.16 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Male-Visit 4 | 219156.5 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Male-Visit 8 | 641581.4 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Biopsy-Male-Visit 9 | 56888.7 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 2 | 1153.16 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 4 | 1153.16 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 5 | 1153.16 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 6 | 1153.16 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 7 | 1153.16 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 8 | 1153.16 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Female-Visit 9 | 1153.16 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 2 | 1153.16 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 4 | 1153.16 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 5 | 1153.16 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 6 | 1153.16 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 7 | 1153.16 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 8 | 1153.16 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Rectal Secretions-Male-Visit 9 | 1153.16 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 2 | 461.26 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 4 | 329345.7 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 5 | 81633.99 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 6 | 579910.8 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 7 | 70942.9 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 8 | 518469.9 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Semen-Male-Visit 9 | 87682.25 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 2 | 1153.16 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 4 | 5006078 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 5 | 436561.2 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 6 | 2999531 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 7 | 649319.1 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 8 | 2640954 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Softcup Fluid-Female-Visit 9 | 176998.6 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Vaginal Biopsy-Female-Visit 2 | 1153.16 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Vaginal Biopsy-Female-Visit 4 | 247847.2 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints | Vaginal Biopsy-Female-Visit 8 | 111503.2 µg/mL |
Primary
Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration
Pharmacokinetic - Binding Antibody Multiplex Assay (PK-BAMA) was used to measure levels of passively infused VRC07-523LS broadly neutralizing monoclonal antibody in participant sera using 5C9 anti-IDiotype antibody (anti-ID). Outcome measure is the concentration of VRC07-523LS.
Time frame: Measured at Visits 2, 4, 5, 6, 7, 8, 9 (Weeks -2, 2, 16, 18, 32, 34, 48).
Population: Overall Number of Participants Analyzed represents the total number of infused participants in each group. Within each group, data are presented separately by sex, so the Number Analyzed per Row reflects the number of participants within each sex subgroup who contributed data for a specific timepoint or measure. Subgroup counts may be smaller than the overall number due to this stratification and the application of assay-specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 7 | 22.5 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 2 | 0.02 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 4 | 100.34 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 5 | 19.23 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 6 | 123.43 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 8 | 135.99 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 9 | 19.71 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 2 | 0.02 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 4 | 95.44 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 5 | 16.7 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 6 | 130.3 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 7 | 23.9 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 8 | 132.29 µg/mL |
| Group 1: Vaccine | Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 9 | 25.34 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 6 | 325.21 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 2 | 0.02 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 2 | 0.02 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 8 | 338.5 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 4 | 220.14 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 4 | 271.78 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 5 | 44.32 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 7 | 45.05 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 6 | 249.19 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 7 | 30.69 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 5 | 46.43 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 8 | 270.93 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Male-Visit 9 | 40.44 µg/mL |
| Group 2: Vaccine | Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration | Serum-Female-Visit 9 | 43.74 µg/mL |
Secondary
Serum Concentration of ADA in Each Group Measured at Multiple Timepoints From Baseline Through the Final Study Visit
Anti-drug dependent antibodies were measured by an ADA assay from specimens obtained from all participants. Tier 3 titers are only available for those participants who had positive for ADA Tiers 1 and 2.
Time frame: Measured at Visits 2, 3, 5, 7, and 9 (Weeks -2, 0, 16, 32, 48). However, Tier 3 ADA titers are only assessed and reported at Visits 2 and 3 (Weeks -2 and 0) for the subset of participants who tested positive for ADA Tiers 1 and 2.
Population: Overall Number of Participants Analyzed represents the total number of infused participants in each group. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Serum Concentration of ADA in Each Group Measured at Multiple Timepoints From Baseline Through the Final Study Visit | VRC07-523LS-Tier 3-Visit 2 | 15 Titer |
| Group 1: Vaccine | Serum Concentration of ADA in Each Group Measured at Multiple Timepoints From Baseline Through the Final Study Visit | VRC07-523LS-Tier 3-Visit 3 | 15 Titer |
| Group 2: Vaccine | Serum Concentration of ADA in Each Group Measured at Multiple Timepoints From Baseline Through the Final Study Visit | VRC07-523LS-Tier 3-Visit 2 | 54 Titer |
| Group 2: Vaccine | Serum Concentration of ADA in Each Group Measured at Multiple Timepoints From Baseline Through the Final Study Visit | VRC07-523LS-Tier 3-Visit 3 | 27 Titer |