HIV Infections
Conditions
Keywords
HIV-1 Infections
Brief summary
This study will evaluate the safety and efficacy of the human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection in high-risk, HIV-uninfected women.
Detailed description
This study will evaluate the safety, tolerability, and efficacy of the VRC01 antibody in preventing HIV-1 infection in healthy women at high risk of HIV infection. Participants will be enrolled from a cohort of heterosexual women in sub-Saharan Africa. An equal number of study participants will be randomized to receive VRC01 mAb by IV infusion at a dose of 10 mg/kg or 30 mg/kg every 8 weeks, or to receive control infusions every 8 weeks. All participants will receive the VRC01 antibody or placebo by intravenous infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72. For 3 days following each infusion, participants will be asked to record and report any symptoms to study researchers. In addition to the infusion visits, participants will attend study visits at Weeks 4, 8 + 5 days, 12, 20, 28, 36, 44, 52, 60, 68, 76, 80, 84, 88, and 92. All study visits will include blood collection and HIV testing and counseling. Select study visits will include a medical history review, physical exam, urine collection, pregnancy testing for participants capable of becoming pregnant, risk reduction counseling, and an interview/questionnaire.
Interventions
BIOLOGICALVRC01
Administered by IV infusion; total dose will vary based on participant's weight
BIOLOGICALPlacebo for VRC01
Sodium Chloride for Injection USP, 0.9%; administered by IV infusion
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
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 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 infusion with verbal demonstration of understanding of all questionnaire items answered incorrectly * Agrees not to enroll in another study of an investigational research agent for the duration of the participant's trial participation * 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 * Persons born Female (assigned female sex at birth) and identifying as a female, who, in the 6 months prior to randomization, has had vaginal and/or anal intercourse with a male partner * All volunteers who have been in a monogamous relationship with an HIV-1 seronegative partner for greater than 1 year are excluded. Laboratory Inclusion Values+ Hematology * Hemoglobin (Hgb) greater than or equal to 10.5 g/dL for volunteers who were born female, greater than or equal to 13.0 g/dL for volunteers who were born male * Platelets greater than or equal to 100,000 cells/mm\^3 Chemistry * Alanine aminotransferase (ALT) less than 2.5 times the institutional upper limit of normal and creatinine less than or equal to 1.25 times the institutional upper limit of normal Virology * HIV uninfected, as defined in the study specific procedures (SSP), within 30 days prior to enrollment Urine * Negative, trace, or 1+ urine protein by dipstick Reproductive Status * Volunteers capable of becoming pregnant: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed at the screening visit and prior to infusion on the day of initial infusion. Persons who are NOT capable of becoming pregnant due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records) are not required to undergo pregnancy testing. * Reproductive status: A volunteer who is capable of becoming pregnant must agree to consistently use effective contraception (see the protocol and SSP for more information) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit. * Volunteers capable of becoming pregnant 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
Exclusion criteria
General * Investigational research agents received within 30 days before first infusion * Body mass index (BMI) greater than or equal to 40 * Pregnant or breastfeeding * Any reactive, indeterminate, or positive HIV test, even if subsequent testing indicates that the individual is not HIV infected. Monoclonal antibodies and vaccines * Previous receipt of humanized or human monoclonal antibodies (mAbs), whether licensed or investigational * HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 703/HPTN 081 Protocol Safety Review Team (PSRT) will determine eligibility on a case-by-case basis. Immune System * Serious adverse reactions to VRC01 formulation components such as sodium citrate, sodium chloride, and L-arginine hydrochloride, including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. * Autoimmune disease, including Type I diabetes mellitus (Not excluded from participation: Volunteer with mild, stable and uncomplicated autoimmune disease that does not require consistent immunosuppressive medication and that, in the judgment of the site investigator, is likely not subject to exacerbation and likely not to complicate reactogenicity and adverse event (AE) assessments) * Immunodeficiency syndrome 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: * 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; or * A condition or process for which signs or symptoms could be confused with reactions to VRC01. * Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or infusion reactions, or a volunteer's ability to give informed consent * Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years. * Asthma, other than mild, well-controlled asthma * Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) * Malignancy (Not excluded from participation: Volunteer who has had malignancy excised surgically and who, in the investigator's estimation, has a reasonable assurance of sustained cure. or who is unlikely to experience recurrence of malignancy during the period of the study) * Seizure disorder: History of seizure(s) within past three years. Also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years. * History of hereditary angioedema, acquired angioedema, or idiopathic angioedema * History of organ or tissue transplantation * Known hepatic or renal dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Documented HIV-1 Infection by the Week 80 Visit | Measured through Week 80. | Prevention efficacy (PE) is measured as 1 minus the ratio (VRC01:control) of cumulative incidences of HIV-1 infection diagnosis between enrollment and the week 80 visit for assessment of the primary efficacy end point. Cumulative incidence was estimated with the Nelson-Aalen estimator for the cumulative hazard function, with stratification according to VRC01 dose and trial. |
| Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Measured at Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72. | The number (percentage) of participants with chemistry and hematology laboratory measures meeting grade 3 AE criteria or above as specified in the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\] is tabulated by treatment group and timepoint. Excludes measures taken prior to exposure to study product at Week 0/Infusion 1. |
| Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Measured through Week 72 (the last infusion visit). | The number (percentage) of participants with early permanent discontinuation of infusions and their reason for discontinuation is summarized by treatment group. Includes all discontinuations documented on a study case report form. |
| Incidence Rate of Early Infusion Discontinuation | Measured through Week 72 (the last infusion visit). | Incidence rate (95% CI) of early infusion discontinuation per 100 person years. Includes discontinuations documented on a study case report form and operational discontinuations defined as 20 consecutive weeks without participant contact. Discontinuations due to pregnancy, death, or HIV-1 infection are right-censored. |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Measured through 3 days after each infusion at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72. | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Measured through 3 days after each infusion at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72. | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, 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, 8, 16, 24, 32, 40, 48, 56, 64, 72. | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities excluding body temperature for a participant. |
| Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72. | For each local laboratory measure, summary statistics are presented by treatment group and timepoint. |
| Chemistry and Hematology Laboratory Measures - Creatinine | Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72. | For each local laboratory measure, summary statistics are presented by treatment group and timepoint. |
| Chemistry and Hematology Laboratory Measures - Hemoglobin | Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72. | For each local laboratory measure, summary statistics are presented by treatment group and timepoint. |
| Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72. | For each local laboratory measure, summary statistics are presented by treatment group and timepoint. |
| Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72. | For each local laboratory measure, summary statistics are presented by treatment group and timepoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VRC01 Clinical Lot Neutralization of Founder Viruses (IC80) | Measured through Week 80. | The VRC01 80% inhibitory concentration (IC80) of acquired isolates was measured with the TZM-bl assay using the earliest available post-HIV-infection serum sample. Median and IQR are summarized immediately below, then the analysis of prevention efficacy was repeated for each of three prespecified categories of in vitro susceptibility of the infecting strain (IC80 less than 1 μg per milliliter, 1 to 3 μg per milliliter, or \>3 μg per milliliter) with the use of the Aalen-Johansen estimator. |
| VRC01 Serum Neutralization of Autologous Founder Viruses (ID50, ID80) | First RNA+ Sample detected from baseline up to Week 104. | Autologous titer (ID50, ID80) summaries, based on most sensitive virus, for first RNA+ samples from a subset of HIV-infected VRC01 recipients. Values below the limit of detection (less than 10) were set to NA. Summaries are only computed for the Pooled VRC01 arm. |
| Serum Concentration of VRC01 in Participants Assigned to Receive the mAb | Day 61 (5 days post infusion #2), Midpoint (4-weeks post infusion visits): Weeks 4, 12, 16, 28, 36, 44, 52, 60, 68, 76 and Trough (infusion visits): Pre dose at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72. | The pharmacokinetic analyses of VRC01 involved a subgroup of VRC01 recipients who had not acquired HIV-1 infection through the week 88 visit and were not likely to have used preexposure prophylaxis (on the basis of self-report or testing of dried blood-spot samples), randomly sampled among the trials and dose groups. Midpoint and trough concentrations are the participant-level median concentrations at the 4-week and 8-week postinfusion visits, respectively, across all 10 infusion intervals. |
Countries
Botswana, Kenya, Malawi, Mozambique, South Africa, Tanzania, Zimbabwe
Participant flow
Pre-assignment details
Participants were randomly assigned to the placebo, low-dose VRC01, or high-dose VRC01 arm. The pooled VRC01 arm represents participants assigned to low-dose or high-dose VRC01 and is the primary comparison group for the primary analysis of prevention efficacy.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72. | 637 |
| Low-Dose VRC01 VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72. | 642 |
| High-Dose VRC01 VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72. | 645 |
| Total | 1,924 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 1 | 2 | 0 |
| Overall Study | Lost to Follow-up | 29 | 32 | 41 |
| Overall Study | Other | 0 | 1 | 4 |
| Overall Study | Participant Unable to Adhere to Visit Schedule | 25 | 23 | 21 |
| Overall Study | Physician Decision | 2 | 2 | 2 |
| Overall Study | Protocol Violation | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 21 | 19 | 22 |
Baseline characteristics
| Characteristic | Placebo | Low-Dose VRC01 | High-Dose VRC01 | Total |
|---|---|---|---|---|
| Age, Continuous | 26 years | 25 years | 26 years | 25 years |
| Age, Customized 18 - 20 years | 84 Participants | 86 Participants | 89 Participants | 259 Participants |
| Age, Customized 21 - 30 years | 408 Participants | 416 Participants | 411 Participants | 1235 Participants |
| Age, Customized 31 - 40 years | 142 Participants | 136 Participants | 142 Participants | 420 Participants |
| Age, Customized 41 - 50 years | 3 Participants | 3 Participants | 3 Participants | 9 Participants |
| Age, Customized Above 50 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Less than 18 years | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Age, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 637 Participants | 642 Participants | 645 Participants | 1924 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 628 Participants | 635 Participants | 639 Participants | 1902 Participants |
| Race/Ethnicity, Customized Colored/Mixed | 3 Participants | 6 Participants | 3 Participants | 12 Participants |
| Race/Ethnicity, Customized Indian | 5 Participants | 1 Participants | 3 Participants | 9 Participants |
| Race/Ethnicity, Customized More than one race | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Botswana | 47 Participants | 52 Participants | 51 Participants | 150 Participants |
| Region of Enrollment Kenya | 27 Participants | 27 Participants | 28 Participants | 82 Participants |
| Region of Enrollment Malawi | 59 Participants | 60 Participants | 61 Participants | 180 Participants |
| Region of Enrollment Mozambique | 8 Participants | 9 Participants | 9 Participants | 26 Participants |
| Region of Enrollment South Africa | 340 Participants | 338 Participants | 341 Participants | 1019 Participants |
| Region of Enrollment Tanzania | 11 Participants | 12 Participants | 10 Participants | 33 Participants |
| Region of Enrollment Zimbabwe | 145 Participants | 144 Participants | 145 Participants | 434 Participants |
| Sex: Female, Male Female | 637 Participants | 642 Participants | 645 Participants | 1924 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 637 | 2 / 642 | 0 / 645 | 2 / 1,287 |
| other Total, other adverse events | 594 / 637 | 587 / 642 | 591 / 645 | 1,178 / 1,287 |
| serious Total, serious adverse events | 26 / 637 | 10 / 642 | 23 / 645 | 33 / 1,287 |
Outcome results
Primary
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
For each local laboratory measure, summary statistics are presented by treatment group and timepoint.
Time frame: Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.
Population: Safety population. Participants may not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 72 | 16 U/L |
| Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 56 | 16 U/L |
| Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 40 | 16 U/L |
| Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 64 | 16 U/L |
| Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 32 | 16 U/L |
| Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 16 | 16 U/L |
| Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 8 | 15 U/L |
| Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 48 | 16 U/L |
| Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 24 | 16 U/L |
| Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 0 | 15 U/L |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 72 | 15 U/L |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 40 | 15 U/L |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 48 | 15 U/L |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 56 | 15 U/L |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 64 | 15 U/L |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 32 | 15 U/L |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 0 | 15 U/L |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 8 | 15 U/L |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 16 | 15 U/L |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 24 | 14 U/L |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 32 | 16 U/L |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 40 | 15 U/L |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 0 | 16 U/L |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 16 | 16 U/L |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 72 | 15 U/L |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 56 | 16 U/L |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 48 | 16 U/L |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 64 | 15 U/L |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 24 | 16 U/L |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 8 | 16 U/L |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 48 | 15 U/L |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 72 | 15 U/L |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 0 | 15 U/L |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 40 | 15 U/L |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 8 | 15 U/L |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 24 | 15 U/L |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 56 | 16 U/L |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 16 | 15 U/L |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 64 | 15 U/L |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 32 | 16 U/L |
Primary
Chemistry and Hematology Laboratory Measures - Creatinine
For each local laboratory measure, summary statistics are presented by treatment group and timepoint.
Time frame: Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.
Population: Safety population. Participants may not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 0 | 0.64 mg/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 8 | 0.65 mg/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 16 | 0.66 mg/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 24 | 0.67 mg/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 32 | 0.66 mg/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 40 | 0.67 mg/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 48 | 0.67 mg/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 56 | 0.67 mg/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 64 | 0.67 mg/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 72 | 0.67 mg/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 16 | 0.66 mg/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 64 | 0.68 mg/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 24 | 0.68 mg/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 32 | 0.67 mg/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 40 | 0.67 mg/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 48 | 0.67 mg/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 72 | 0.68 mg/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 56 | 0.67 mg/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 0 | 0.66 mg/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 8 | 0.66 mg/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 56 | 0.68 mg/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 48 | 0.68 mg/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 72 | 0.68 mg/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 0 | 0.67 mg/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 24 | 0.67 mg/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 40 | 0.68 mg/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 64 | 0.68 mg/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 8 | 0.66 mg/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 32 | 0.67 mg/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 16 | 0.67 mg/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 32 | 0.67 mg/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 56 | 0.68 mg/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 40 | 0.67 mg/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 72 | 0.68 mg/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 48 | 0.68 mg/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 8 | 0.66 mg/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 16 | 0.67 mg/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 24 | 0.67 mg/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 0 | 0.66 mg/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 64 | 0.68 mg/dL |
Primary
Chemistry and Hematology Laboratory Measures - Hemoglobin
For each local laboratory measure, summary statistics are presented by treatment group and timepoint.
Time frame: Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.
Population: Safety population. Participants may not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 0 | 13.4 g/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 8 | 13.2 g/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 16 | 13.2 g/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 24 | 13.1 g/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 32 | 13.1 g/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 40 | 13.1 g/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 48 | 13 g/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 56 | 13.1 g/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 64 | 13 g/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 72 | 13 g/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 16 | 13.1 g/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 64 | 13 g/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 24 | 13.1 g/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 32 | 13.1 g/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 40 | 13.15 g/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 48 | 13.1 g/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 72 | 13 g/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 56 | 13 g/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 0 | 13.4 g/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 8 | 13.2 g/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 56 | 13.1 g/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 48 | 13.2 g/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 72 | 13.1 g/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 0 | 13.6 g/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 24 | 13.1 g/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 40 | 13.2 g/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 64 | 13.1 g/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 8 | 13.3 g/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 32 | 13.2 g/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 16 | 13.2 g/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 32 | 13.1 g/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 56 | 13.1 g/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 40 | 13.2 g/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 72 | 13 g/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 48 | 13.1 g/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 8 | 13.2 g/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 16 | 13.1 g/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 24 | 13.1 g/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 0 | 13.5 g/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 64 | 13.1 g/dL |
Primary
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
For each local laboratory measure, summary statistics are presented by treatment group and timepoint.
Time frame: Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.
Population: Safety population. Participants may not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 40 | 2910 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 8 | 2940.5 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 24 | 2124.5 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 32 | 2830 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 16 | 2868.5 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 0 | 2172 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 24 | 2858 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 8 | 2148 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 64 | 2834 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 32 | 2125.5 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 40 | 2110.5 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 56 | 3000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 48 | 2111 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 72 | 2868.5 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 56 | 2082.5 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 16 | 2120 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 48 | 2920 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 64 | 2070 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 72 | 2109.5 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 0 | 3008 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 40 | 2888.5 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 0 | 2999 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 64 | 2918 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 32 | 2881 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 40 | 2052 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 8 | 2905.5 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 0 | 2123 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 72 | 2880 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 72 | 2040 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 16 | 2821 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 48 | 2042 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 24 | 2924 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 64 | 2029 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 24 | 2042 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 48 | 2990 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 16 | 2060 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 56 | 2000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 32 | 2040 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 8 | 2050 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 56 | 2940 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 16 | 3046.5 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 0 | 2180 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 8 | 2145.5 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 16 | 2082.5 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 24 | 2091 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 32 | 2074.5 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 40 | 2110 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 48 | 2148 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 56 | 2120.5 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 64 | 2106 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 72 | 2150 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 0 | 3200 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 8 | 3070 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 24 | 2922 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 32 | 2988 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 40 | 3065 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 48 | 2994 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 56 | 2955.5 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 64 | 2970 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 72 | 2970 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 72 | 2090 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 64 | 2068.5 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 64 | 2944 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 40 | 3020.5 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 56 | 2051 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 48 | 2080 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 8 | 2100 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 48 | 2992.5 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 40 | 2080 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 32 | 2060 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 0 | 2160 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 56 | 2945 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 24 | 2067 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 16 | 2950 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 16 | 2070 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 24 | 2923 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 8 | 2985 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 0 | 3107.5 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 72 | 2920 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 32 | 2943 cells/cubic mm |
Primary
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
The number (percentage) of participants with chemistry and hematology laboratory measures meeting grade 3 AE criteria or above as specified in the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\] is tabulated by treatment group and timepoint. Excludes measures taken prior to exposure to study product at Week 0/Infusion 1.
Time frame: Measured at Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72.
Population: Safety population. Participants may not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 8 | 1 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 24 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 48 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 48 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 56 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 72 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 16 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 64 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 72 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 8 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 8 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 16 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 8 | 1 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 72 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 24 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 32 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 64 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 40 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 40 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 48 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 16 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 56 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 24 | 1 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 32 | 1 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 32 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 32 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 40 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 16 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 24 | 1 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 64 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 56 | 1 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 40 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 16 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 64 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 72 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 8 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 8 | 5 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 16 | 2 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 48 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 72 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 24 | 2 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 32 | 6 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 48 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 64 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 40 | 7 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 48 | 3 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 56 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 56 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 56 | 5 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 56 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 64 | 4 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 48 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 72 | 7 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 72 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 8 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 40 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 16 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 64 | 1 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 24 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 32 | 1 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 32 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 24 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 40 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 48 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 64 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 64 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 48 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 40 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 16 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 8 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 56 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 56 | 2 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 72 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 16 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 64 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 72 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 8 | 1 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 40 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 72 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 24 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 48 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 8 | 1 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 8 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 40 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 72 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 56 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 16 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 72 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 16 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 16 | 3 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 24 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 8 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 64 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 64 | 1 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 32 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 72 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 56 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 24 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 40 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 24 | 4 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 56 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 48 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 48 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 64 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 32 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 16 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 64 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 32 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 32 | 2 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 24 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 72 | 1 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 32 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 40 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 32 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 32 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 24 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 40 | 2 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 40 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 8 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 56 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 48 | 1 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 24 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 16 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 48 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 56 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 8 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 40 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 8 | 2 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 16 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 24 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 32 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 40 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 48 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 56 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 64 | 1 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 72 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 8 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 16 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 24 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 32 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 40 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 48 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 56 | 1 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 64 | 2 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 72 | 1 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 8 | 4 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 16 | 3 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 24 | 5 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 32 | 5 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 40 | 3 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 48 | 5 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 56 | 4 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 64 | 4 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 72 | 1 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 8 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 16 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 24 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 32 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 48 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 56 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 64 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 72 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 8 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 16 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 24 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 32 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 40 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 48 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 56 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 64 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 72 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 8 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 16 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 24 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 32 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 40 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 48 | 1 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 56 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 64 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 72 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 8 | 1 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 16 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 24 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 32 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 40 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 48 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 56 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 64 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 72 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 32 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 64 | 1 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 24 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 24 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 16 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 56 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 32 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 8 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 72 | 2 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 16 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 40 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 64 | 5 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 56 | 6 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 48 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 48 | 1 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 48 | 5 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 40 | 5 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 48 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 56 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 32 | 7 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 24 | 9 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 40 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 64 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 16 | 6 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 8 | 5 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 8 | 2 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 72 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 72 | 1 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 64 | 2 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 56 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 8 | 1 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 56 | 1 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 48 | 1 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 32 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 16 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 40 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 32 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 24 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 24 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 24 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 16 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 72 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 48 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 40 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 32 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 56 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 32 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 24 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 8 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 64 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 16 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 8 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 72 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000 cells/cubic mm)- Week 72 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 72 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 64 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 64 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 8 | 1 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 56 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 48 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 40 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 16 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000 cells/cubic mm)- Week 40 | 0 Participants |
Primary
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
For each local laboratory measure, summary statistics are presented by treatment group and timepoint.
Time frame: Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.
Population: Safety population. Participants may not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 40 | 276 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 0 | 5.76 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 8 | 271 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 32 | 272 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 16 | 275 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 24 | 5.57 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 24 | 277 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 64 | 271.5 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 32 | 5.6 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 8 | 5.72 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 56 | 274 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 40 | 5.6 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 48 | 5.6 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 56 | 5.65 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 72 | 274 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 48 | 270 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 64 | 5.52 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 16 | 5.54 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 72 | 5.57 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 0 | 272 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 72 | 5.57 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 0 | 275 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 40 | 281 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 32 | 277 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 40 | 5.6 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 8 | 275 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 64 | 274 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 8 | 5.55 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 48 | 279 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 16 | 275 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 16 | 5.53 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 24 | 278 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 48 | 5.64 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 24 | 5.58 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 72 | 276.5 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 0 | 5.76 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 64 | 5.6 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 32 | 5.6 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 56 | 5.54 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 56 | 274 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 16 | 5.71 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 0 | 6.1 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 8 | 5.75 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 24 | 5.6 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 32 | 5.76 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 40 | 5.75 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 48 | 5.79 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 56 | 5.62 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 64 | 5.62 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 72 | 5.77 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 0 | 279 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 8 | 282 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 16 | 280 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 24 | 283 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 32 | 285 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 40 | 285 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 48 | 282 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 56 | 280 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 64 | 282 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 72 | 281 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 72 | 5.66 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 64 | 5.61 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 64 | 277 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 40 | 283 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 56 | 5.6 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 40 | 5.67 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 8 | 5.63 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 48 | 281 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 48 | 5.69 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 32 | 5.69 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 0 | 5.9 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 56 | 277 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 24 | 5.6 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 16 | 278 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 16 | 5.63 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 24 | 280 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 8 | 279 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 0 | 277 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 72 | 278.5 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 32 | 282 1000 cells/cubic mm |
Primary
Incidence Rate of Early Infusion Discontinuation
Incidence rate (95% CI) of early infusion discontinuation per 100 person years. Includes discontinuations documented on a study case report form and operational discontinuations defined as 20 consecutive weeks without participant contact. Discontinuations due to pregnancy, death, or HIV-1 infection are right-censored.
Time frame: Measured through Week 72 (the last infusion visit).
Population: Safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Incidence Rate of Early Infusion Discontinuation | 5.3 events per 100 person years |
| Low-Dose VRC01 | Incidence Rate of Early Infusion Discontinuation | 8.7 events per 100 person years |
| High-Dose VRC01 | Incidence Rate of Early Infusion Discontinuation | 8 events per 100 person years |
Primary
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, 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, 8, 16, 24, 32, 40, 48, 56, 64, 72.
Population: Safety population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None or Not Gradable | 618 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 6.25 to less than 25 sq.cm or 2.5 to less than 5 cm single dim. | 20 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: >=100 sq.cm or >=10 cm single dim or severe complication | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 2: 25 to less than 100 sq.cm or 5 to less than 10 cm single dim. | 7 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 4: Potentially Life-Threatening complication | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None or Not Gradable | 610 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: >=100 sq.cm or >=10 cm single dim or severe complication | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 1: 6.25 to less than 25 sq.cm or 2.5 to less than 5 cm single dim. | 12 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >=100 sq.cm or >=10 cm single dim or severe complication | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 4: Potentially Life-Threatening complication | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None or Not Gradable | 623 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 25 to less than 100 sq.cm or 5 to less than 10 cm single dim. | 7 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 1: 6.25 to less than 25 sq.cm or 2.5 to less than 5 cm single dim. | 12 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 4: Potentially Life-Threatening complication | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 2: 25 to less than 100 sq.cm or 5 to less than 10 cm single dim. | 2 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 2: 25 to less than 100 sq.cm or 5 to less than 10 cm single dim. | 1 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 6.25 to less than 25 sq.cm or 2.5 to less than 5 cm single dim. | 22 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 4: Potentially Life-Threatening complication | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: >=100 sq.cm or >=10 cm single dim or severe complication | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 1: 6.25 to less than 25 sq.cm or 2.5 to less than 5 cm single dim. | 17 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None or Not Gradable | 612 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 25 to less than 100 sq.cm or 5 to less than 10 cm single dim. | 8 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 4: Potentially Life-Threatening complication | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 2: 25 to less than 100 sq.cm or 5 to less than 10 cm single dim. | 7 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 1: 6.25 to less than 25 sq.cm or 2.5 to less than 5 cm single dim. | 9 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 4: Potentially Life-Threatening complication | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >=100 sq.cm or >=10 cm single dim or severe complication | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None or Not Gradable | 632 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: >=100 sq.cm or >=10 cm single dim or severe complication | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None or Not Gradable | 618 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 2: 25 to less than 100 sq.cm or 5 to less than 10 cm single dim. | 1 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None or Not Gradable | 629 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 1: 6.25 to less than 25 sq.cm or 2.5 to less than 5 cm single dim. | 12 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 2: 25 to less than 100 sq.cm or 5 to less than 10 cm single dim. | 4 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: >=100 sq.cm or >=10 cm single dim or severe complication | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 4: Potentially Life-Threatening complication | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None or Not Gradable | 639 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 1: 6.25 to less than 25 sq.cm or 2.5 to less than 5 cm single dim. | 5 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: >=100 sq.cm or >=10 cm single dim or severe complication | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 4: Potentially Life-Threatening complication | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None or Not Gradable | 627 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 6.25 to less than 25 sq.cm or 2.5 to less than 5 cm single dim. | 13 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 25 to less than 100 sq.cm or 5 to less than 10 cm single dim. | 5 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >=100 sq.cm or >=10 cm single dim or severe complication | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 4: Potentially Life-Threatening complication | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 1: 6.25 to less than 25 sq.cm or 2.5 to less than 5 cm single dim. | 14 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 1: 6.25 to less than 25 sq.cm or 2.5 to less than 5 cm single dim. | 29 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 6.25 to less than 25 sq.cm or 2.5 to less than 5 cm single dim. | 35 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None or Not Gradable | 1271 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 4: Potentially Life-Threatening complication | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None or Not Gradable | 1247 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 25 to less than 100 sq.cm or 5 to less than 10 cm single dim. | 13 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: >=100 sq.cm or >=10 cm single dim or severe complication | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 2: 25 to less than 100 sq.cm or 5 to less than 10 cm single dim. | 11 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 4: Potentially Life-Threatening complication | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 4: Potentially Life-Threatening complication | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: >=100 sq.cm or >=10 cm single dim or severe complication | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >=100 sq.cm or >=10 cm single dim or severe complication | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None or Not Gradable | 1239 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 2: 25 to less than 100 sq.cm or 5 to less than 10 cm single dim. | 2 Participants |
Primary
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, 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, 8, 16, 24, 32, 40, 48, 56, 64, 72.
Population: Safety population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | None | 476 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Mild | 162 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Moderate | 19 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | None | 452 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Mild | 142 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | None | 518 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Moderate | 23 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Mild | 104 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Moderate | 15 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Moderate | 13 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Mild | 133 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Potentially Life-threatening | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Severe | 1 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Mild | 120 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | None | 482 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Moderate | 26 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Potentially Life-threatening | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Moderate | 26 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Mild | 81 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Severe | 1 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | None | 547 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Severe | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | None | 496 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Moderate | 13 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | None | 506 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Mild | 120 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Moderate | 16 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Severe | 3 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Potentially Life-threatening | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | None | 543 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Mild | 87 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Severe | 2 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Potentially Life-threatening | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | None | 476 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Mild | 144 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Moderate | 22 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Severe | 3 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Mild | 168 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Mild | 240 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Mild | 277 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | None | 1090 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Potentially Life-threatening | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | None | 1002 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Moderate | 48 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Severe | 3 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Moderate | 42 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Potentially Life-threatening | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Severe | 3 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Severe | 4 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | None | 958 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Moderate | 26 Participants |
Primary
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities excluding body temperature for a participant.
Time frame: Measured through 3 days after each infusion at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.
Population: Safety population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | Mild | 15 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 43 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 589 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 577 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 40 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 8 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 382 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | None | 609 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 198 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 8 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 57 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 549 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | Severe | 3 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 76 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 17 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 12 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 72 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 603 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | Moderate | 10 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 246 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 26 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 561 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 19 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 319 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 473 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 134 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 57 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 30 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 122 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 28 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 328 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 487 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 70 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 574 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 84 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 3 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 576 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 7 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 591 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 12 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 565 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 43 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | Potentially Life-threatening | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | Mild | 14 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 8 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | None | 610 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | Moderate | 16 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 230 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 394 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | Severe | 2 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 33 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 182 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 66 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 18 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 54 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 611 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 50 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 188 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 28 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 36 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 54 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 12 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 387 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 70 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 567 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 65 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 13 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 614 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 3 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 579 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 495 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 107 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 42 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 1 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 599 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 37 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 9 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 596 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 13 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 326 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 233 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 85 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 1 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | None | 616 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | Mild | 20 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | Moderate | 7 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | Severe | 2 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | Potentially Life-threatening | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 229 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 982 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 1153 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 463 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 6 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 370 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 654 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 1225 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | Moderate | 23 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 20 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 135 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 90 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 169 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 1132 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 56 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 1 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 136 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | Potentially Life-threatening | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 781 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | Severe | 4 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | None | 1226 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 30 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 17 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 80 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 1190 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | Mild | 34 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 1172 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 104 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 25 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 1 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 75 Participants |
Primary
Number of Participants With Documented HIV-1 Infection by the Week 80 Visit
Prevention efficacy (PE) is measured as 1 minus the ratio (VRC01:control) of cumulative incidences of HIV-1 infection diagnosis between enrollment and the week 80 visit for assessment of the primary efficacy end point. Cumulative incidence was estimated with the Nelson-Aalen estimator for the cumulative hazard function, with stratification according to VRC01 dose and trial.
Time frame: Measured through Week 80.
Population: MITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Documented HIV-1 Infection by the Week 80 Visit | 29 Participants |
| Low-Dose VRC01 | Number of Participants With Documented HIV-1 Infection by the Week 80 Visit | 28 Participants |
| High-Dose VRC01 | Number of Participants With Documented HIV-1 Infection by the Week 80 Visit | 19 Participants |
| Pooled VRC01 | Number of Participants With Documented HIV-1 Infection by the Week 80 Visit | 47 Participants |
Comparison: The primary PE analysis tests the null hypothesis PE equal to zero versus the alternative hypothesis PE not equal to zero using a 2-sided alpha equal 0.05 level Wald test of the equality of log cumulative hazard functions at the week 80 visit for the pooled VRC01 group versus the placebo group.p-value: 0.795% CI: [-45.1, 42.6]wald
Comparison: A secondary analysis assesses the overall PE of the low-dose VRC01 group versus the placebo group.95% CI: [-85.3, 35.5]
Comparison: A secondary analysis assesses the overall PE of the high-dose VRC01 group versus the placebo group.95% CI: [-30.7, 59.3]
Primary
Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation
The number (percentage) of participants with early permanent discontinuation of infusions and their reason for discontinuation is summarized by treatment group. Includes all discontinuations documented on a study case report form.
Time frame: Measured through Week 72 (the last infusion visit).
Population: Safety population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Other | 6 Participants |
| Placebo | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | No Discontinuation | 560 Participants |
| Placebo | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Co-enrollment in a study | 1 Participants |
| Placebo | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Pregnancy | 2 Participants |
| Placebo | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Two(2) reactive HIV tests | 1 Participants |
| Placebo | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Death | 0 Participants |
| Placebo | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Clinical event other than reactogenicity | 3 Participants |
| Placebo | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | HIV infection | 28 Participants |
| Placebo | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Termination from study for non-medical reason(s) | 30 Participants |
| Placebo | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Reactogenicity Symptom | 0 Participants |
| Placebo | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Investigator Reason | 4 Participants |
| Placebo | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Participant refused study product infusion | 2 Participants |
| Low-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | HIV infection | 25 Participants |
| Low-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Participant refused study product infusion | 4 Participants |
| Low-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Clinical event other than reactogenicity | 16 Participants |
| Low-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Two(2) reactive HIV tests | 2 Participants |
| Low-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Other | 8 Participants |
| Low-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Co-enrollment in a study | 0 Participants |
| Low-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Pregnancy | 2 Participants |
| Low-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Investigator Reason | 2 Participants |
| Low-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Reactogenicity Symptom | 6 Participants |
| Low-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Death | 0 Participants |
| Low-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | No Discontinuation | 545 Participants |
| Low-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Termination from study for non-medical reason(s) | 32 Participants |
| High-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Co-enrollment in a study | 0 Participants |
| High-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Pregnancy | 0 Participants |
| High-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | HIV infection | 15 Participants |
| High-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Death | 0 Participants |
| High-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Clinical event other than reactogenicity | 24 Participants |
| High-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Reactogenicity Symptom | 2 Participants |
| High-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Investigator Reason | 6 Participants |
| High-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Participant refused study product infusion | 6 Participants |
| High-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Two(2) reactive HIV tests | 2 Participants |
| High-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Other | 10 Participants |
| High-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Termination from study for non-medical reason(s) | 26 Participants |
| High-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | No Discontinuation | 554 Participants |
| Pooled VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Investigator Reason | 8 Participants |
| Pooled VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Reactogenicity Symptom | 8 Participants |
| Pooled VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Pregnancy | 2 Participants |
| Pooled VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Other | 18 Participants |
| Pooled VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Clinical event other than reactogenicity | 40 Participants |
| Pooled VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Death | 0 Participants |
| Pooled VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | No Discontinuation | 1099 Participants |
| Pooled VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Termination from study for non-medical reason(s) | 58 Participants |
| Pooled VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Co-enrollment in a study | 0 Participants |
| Pooled VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Participant refused study product infusion | 10 Participants |
| Pooled VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | HIV infection | 40 Participants |
| Pooled VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Two(2) reactive HIV tests | 4 Participants |
Secondary
Serum Concentration of VRC01 in Participants Assigned to Receive the mAb
The pharmacokinetic analyses of VRC01 involved a subgroup of VRC01 recipients who had not acquired HIV-1 infection through the week 88 visit and were not likely to have used preexposure prophylaxis (on the basis of self-report or testing of dried blood-spot samples), randomly sampled among the trials and dose groups. Midpoint and trough concentrations are the participant-level median concentrations at the 4-week and 8-week postinfusion visits, respectively, across all 10 infusion intervals.
Time frame: Day 61 (5 days post infusion #2), Midpoint (4-weeks post infusion visits): Weeks 4, 12, 16, 28, 36, 44, 52, 60, 68, 76 and Trough (infusion visits): Pre dose at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Population: Pilot study population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Serum Concentration of VRC01 in Participants Assigned to Receive the mAb | 4-week post infusion visit | 19.8 μg/ml |
| Placebo | Serum Concentration of VRC01 in Participants Assigned to Receive the mAb | 8-week post infusion visit | 4.7 μg/ml |
| Placebo | Serum Concentration of VRC01 in Participants Assigned to Receive the mAb | Day 61 | 88.9 μg/ml |
| Low-Dose VRC01 | Serum Concentration of VRC01 in Participants Assigned to Receive the mAb | 4-week post infusion visit | 44.7 μg/ml |
| Low-Dose VRC01 | Serum Concentration of VRC01 in Participants Assigned to Receive the mAb | 8-week post infusion visit | 8.3 μg/ml |
| Low-Dose VRC01 | Serum Concentration of VRC01 in Participants Assigned to Receive the mAb | Day 61 | 257.9 μg/ml |
Secondary
VRC01 Clinical Lot Neutralization of Founder Viruses (IC80)
The VRC01 80% inhibitory concentration (IC80) of acquired isolates was measured with the TZM-bl assay using the earliest available post-HIV-infection serum sample. Median and IQR are summarized immediately below, then the analysis of prevention efficacy was repeated for each of three prespecified categories of in vitro susceptibility of the infecting strain (IC80 less than 1 μg per milliliter, 1 to 3 μg per milliliter, or \>3 μg per milliliter) with the use of the Aalen-Johansen estimator.
Time frame: Measured through Week 80.
Population: MITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | VRC01 Clinical Lot Neutralization of Founder Viruses (IC80) | 4.39 μg/ml |
| Low-Dose VRC01 | VRC01 Clinical Lot Neutralization of Founder Viruses (IC80) | 4.54 μg/ml |
| High-Dose VRC01 | VRC01 Clinical Lot Neutralization of Founder Viruses (IC80) | 22.8 μg/ml |
| Pooled VRC01 | VRC01 Clinical Lot Neutralization of Founder Viruses (IC80) | 5.32 μg/ml |
Comparison: PE against IC80 of least sensitive variant less than 195% CI: [17.3, 94.4]
Comparison: PE against IC80 of least sensitive variant 1-395% CI: [-187.5, 70.2]
Comparison: PE against IC80 of least sensitive variant \> 395% CI: [-83.1, 43.3]
Secondary
VRC01 Serum Neutralization of Autologous Founder Viruses (ID50, ID80)
Autologous titer (ID50, ID80) summaries, based on most sensitive virus, for first RNA+ samples from a subset of HIV-infected VRC01 recipients. Values below the limit of detection (less than 10) were set to NA. Summaries are only computed for the Pooled VRC01 arm.
Time frame: First RNA+ Sample detected from baseline up to Week 104.
Population: Subset of HIV-infected VRC01 recipients
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | VRC01 Serum Neutralization of Autologous Founder Viruses (ID50, ID80) | ID50 | NA titer |
| Placebo | VRC01 Serum Neutralization of Autologous Founder Viruses (ID50, ID80) | ID80 | NA titer |