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 among men and transgender (TG) persons who have sex with men, in North America, South America, and Switzerland.
Detailed description
This study will evaluate the safety, tolerability, and efficacy of the VRC01 antibody in preventing HIV-1 infection in men and transgender (TG) persons who have sex with men, in North America, South America, and Switzerland. Participants will be randomized to receive VRC01 mAb by intravenous (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 IV 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, 88, 96, and 104. 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
MALE
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 Male or identifying as Transgender (TG) (male-to-female or female-to-male, see HVTN 704/HPTN 085 SSP) who, in the 6 months prior to randomization, experienced 1 or both of the following HIV risk criteria: * Condomless anal intercourse with 1 or more male or transgender partner(s) * Anal intercourse with 2 or more male or transgender partners * Male-to-female and female-to-male TG volunteers are eligible. Receipt of hormonal therapy does not make a TG volunteer ineligible. * Volunteers who have been in a mutually 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 (greater than or equal to 12.0 g/dL for transgender women taking feminizing hormones \[e.g., anti-androgens, estrogens\]) * 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 SSP, within 30 days prior to enrollment Urine * Negative, trace, or 1+ (30 g/L for semi-quantitative) 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, except as permitted by the HVTN 704/HPTN 085 Protocol Safety Review Team (PSRT). Vaccines * HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 704/HPTN 085 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 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 receiving transplantation of life-saving organs or tissues (includes heart, kidney, pancreas, lungs, liver, and intestines) * 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
Brazil, Peru, Switzerland, United States
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. | 903 |
| 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. | 899 |
| 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. | 897 |
| Total | 2,699 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 2 | 3 | 0 |
| Overall Study | Lost to Follow-up | 100 | 87 | 99 |
| Overall Study | Other | 38 | 47 | 48 |
| Overall Study | Participant Unable to Adhere to Visit Schedule | 36 | 31 | 42 |
| Overall Study | Physician Decision | 2 | 1 | 1 |
| Overall Study | Protocol Violation | 0 | 3 | 1 |
| Overall Study | Withdrawal by Subject | 22 | 25 | 20 |
Baseline characteristics
| Characteristic | Low-Dose VRC01 | High-Dose VRC01 | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 28 years | 27 years | 28 years | 28 years |
| Age, Customized 18 - 20 years | 94 Participants | 106 Participants | 95 Participants | 295 Participants |
| Age, Customized 21 - 30 years | 474 Participants | 480 Participants | 496 Participants | 1450 Participants |
| Age, Customized 31 - 40 years | 253 Participants | 208 Participants | 232 Participants | 693 Participants |
| Age, Customized 41 - 50 years | 77 Participants | 103 Participants | 80 Participants | 260 Participants |
| Age, Customized Above 50 years | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Customized Less than 18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 517 Participants | 495 Participants | 532 Participants | 1544 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 382 Participants | 402 Participants | 371 Participants | 1155 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 7 Participants | 3 Participants | 6 Participants | 16 Participants |
| Race (NIH/OMB) Asian | 29 Participants | 18 Participants | 22 Participants | 69 Participants |
| Race (NIH/OMB) Black or African American | 132 Participants | 144 Participants | 132 Participants | 408 Participants |
| Race (NIH/OMB) More than one race | 32 Participants | 24 Participants | 32 Participants | 88 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 425 Participants | 413 Participants | 421 Participants | 1259 Participants |
| Race (NIH/OMB) White | 272 Participants | 293 Participants | 286 Participants | 851 Participants |
| Region of Enrollment Brazil | 49 Participants | 51 Participants | 51 Participants | 151 Participants |
| Region of Enrollment Peru | 374 Participants | 377 Participants | 380 Participants | 1131 Participants |
| Region of Enrollment Switzerland | 12 Participants | 12 Participants | 12 Participants | 36 Participants |
| Region of Enrollment United States | 464 Participants | 457 Participants | 460 Participants | 1381 Participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 11 Participants | 26 Participants |
| Sex: Female, Male Male | 892 Participants | 889 Participants | 892 Participants | 2673 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 | 2 / 903 | 3 / 899 | 0 / 897 | 3 / 1,796 |
| other Total, other adverse events | 750 / 903 | 771 / 899 | 742 / 897 | 1,513 / 1,796 |
| serious Total, serious adverse events | 32 / 903 | 35 / 899 | 32 / 897 | 67 / 1,796 |
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 0 | 25 U/L |
| Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 8 | 24 U/L |
| Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 16 | 23 U/L |
| Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 24 | 24 U/L |
| Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 32 | 24 U/L |
| Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 40 | 23 U/L |
| Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 48 | 23 U/L |
| Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 56 | 22 U/L |
| Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 64 | 22 U/L |
| Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 72 | 22 U/L |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 16 | 23 U/L |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 64 | 22 U/L |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 24 | 23 U/L |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 32 | 23 U/L |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 40 | 22 U/L |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 48 | 23 U/L |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 72 | 22 U/L |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 56 | 22 U/L |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 0 | 24 U/L |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 8 | 24 U/L |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 56 | 22 U/L |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 48 | 22 U/L |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 72 | 22 U/L |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 0 | 24 U/L |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 24 | 23 U/L |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 40 | 22 U/L |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 64 | 22 U/L |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 8 | 24 U/L |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 32 | 23 U/L |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 16 | 24 U/L |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 32 | 23 U/L |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 56 | 22 U/L |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 40 | 22 U/L |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 72 | 22 U/L |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 48 | 22 U/L |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 8 | 24 U/L |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 16 | 23 U/L |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 24 | 23 U/L |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 0 | 24 U/L |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Week 64 | 22 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 | 0.86 mg/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 8 | 0.87 mg/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 16 | 0.88 mg/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 24 | 0.87 mg/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 32 | 0.88 mg/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 40 | 0.88 mg/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 48 | 0.88 mg/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 56 | 0.88 mg/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 64 | 0.88 mg/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 72 | 0.89 mg/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 16 | 0.87 mg/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 64 | 0.89 mg/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 24 | 0.88 mg/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 32 | 0.87 mg/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 40 | 0.88 mg/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 48 | 0.89 mg/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 72 | 0.88 mg/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 56 | 0.89 mg/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 0 | 0.86 mg/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 8 | 0.86 mg/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 56 | 0.88 mg/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 48 | 0.89 mg/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 72 | 0.89 mg/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 0 | 0.86 mg/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 24 | 0.88 mg/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 40 | 0.88 mg/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 64 | 0.89 mg/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 8 | 0.88 mg/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 32 | 0.87 mg/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 16 | 0.87 mg/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 32 | 0.87 mg/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 56 | 0.88 mg/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 40 | 0.88 mg/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 72 | 0.89 mg/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 48 | 0.89 mg/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 8 | 0.87 mg/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 16 | 0.87 mg/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 24 | 0.88 mg/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 0 | 0.86 mg/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Week 64 | 0.89 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 | 14.9 g/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 8 | 14.7 g/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 16 | 14.7 g/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 24 | 14.6 g/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 32 | 14.6 g/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 40 | 14.6 g/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 48 | 14.6 g/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 56 | 14.6 g/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 64 | 14.6 g/dL |
| Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 72 | 14.5 g/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 16 | 14.7 g/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 64 | 14.5 g/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 24 | 14.6 g/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 32 | 14.6 g/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 40 | 14.5 g/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 48 | 14.6 g/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 72 | 14.5 g/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 56 | 14.6 g/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 0 | 14.8 g/dL |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 8 | 14.7 g/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 56 | 14.6 g/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 48 | 14.6 g/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 72 | 14.5 g/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 0 | 14.9 g/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 24 | 14.7 g/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 40 | 14.6 g/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 64 | 14.6 g/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 8 | 14.8 g/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 32 | 14.7 g/dL |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 16 | 14.7 g/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 32 | 14.6 g/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 56 | 14.6 g/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 40 | 14.6 g/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 72 | 14.5 g/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 48 | 14.6 g/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 8 | 14.7 g/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 16 | 14.7 g/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 24 | 14.7 g/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 0 | 14.8 g/dL |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Week 64 | 14.5 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 | 3310 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 8 | 3410 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 24 | 1950 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 32 | 3344 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 16 | 3378 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 0 | 1988.5 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 24 | 3330 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 8 | 1926 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 64 | 3245 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 32 | 1957 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 40 | 1890 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 56 | 3340 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 48 | 1923.5 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 72 | 3286.5 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 56 | 1910 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 16 | 1927.5 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 48 | 3322 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 64 | 1922 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 72 | 1940 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 0 | 3586 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 40 | 3260 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 0 | 3593 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 64 | 3240 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 32 | 3360 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 40 | 1900 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 8 | 3460 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 0 | 1980 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 72 | 3245 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 72 | 1930 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 16 | 3377 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 48 | 1923 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 24 | 3417 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 64 | 1890 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 24 | 1925 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 48 | 3284.5 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 16 | 1896 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 56 | 1887.5 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 32 | 1930 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 8 | 1904 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 56 | 3238.5 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 16 | 3360 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 0 | 1971 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 8 | 1947.5 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 16 | 1915.5 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 24 | 1911 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 32 | 1900 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 40 | 1879 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 48 | 1870 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 56 | 1900.5 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 64 | 1870 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 72 | 1900 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 0 | 3534 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 8 | 3424 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 24 | 3306 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 32 | 3336 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 40 | 3300 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 48 | 3266.5 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 56 | 3200 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 64 | 3228 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 72 | 3304 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 72 | 1910 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 64 | 1880 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 64 | 3230 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 40 | 3287 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 56 | 1895.5 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 48 | 1900 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 8 | 1930 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 48 | 3278 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 40 | 1890 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 32 | 1920 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 0 | 1978.5 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 56 | 3212.5 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 24 | 1920 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 16 | 3361.5 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (cells/cubic mm)- Week 16 | 1900.5 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 24 | 3357.5 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 8 | 3437 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 0 | 3571.5 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 72 | 3272 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (cells/cubic mm)- Week 32 | 3350 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 | Lymphocytes (cells/cubic mm)- Week 8 | 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 | Neutrophils (cells/cubic mm)- Week 40 | 0 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 8 | 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 | Platelets (1000/cubic mm)- Week 64 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/cubic mm)- Week 40 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/cubic mm)- Week 8 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 8 | 7 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 | WBC (1000/cubic mm)- Week 64 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/cubic mm)- Week 48 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 16 | 3 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 8 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000/cubic mm)- 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 | 6 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/cubic mm)- Week 56 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 48 | 4 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/cubic mm)- Week 16 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 32 | 4 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000/cubic mm)- Week 56 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 24 | 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 | 5 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 24 | 1 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 32 | 2 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 | Creatinine (mg/dL)- Week 48 | 3 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 | 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 | 1 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 | Platelets (1000/cubic mm)- Week 72 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 56 | 1 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/cubic mm)- Week 24 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 64 | 3 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000/cubic mm)- Week 72 | 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 | 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 | 4 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 72 | 1 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 | ALT (SGPT) (U/L)- Week 16 | 1 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000/cubic mm)- Week 8 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 24 | 0 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 40 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000/cubic mm)- Week 16 | 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 | ALT (SGPT) (U/L)- Week 64 | 3 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 | WBC (1000/cubic mm)- Week 24 | 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 56 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 32 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000/cubic mm)- Week 32 | 0 Participants |
| Placebo | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/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 | 3 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 | WBC (1000/cubic mm)- Week 40 | 0 Participants |
| Placebo | 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 | WBC (1000/cubic mm)- Week 40 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000/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 16 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000/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 72 | 3 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000/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 24 | 2 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 8 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000/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 40 | 1 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/cubic mm)- Week 8 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/cubic mm)- Week 72 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/cubic mm)- Week 16 | 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/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 72 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/cubic mm)- Week 64 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/cubic mm)- Week 32 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/cubic mm)- Week 40 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/cubic mm)- Week 56 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/cubic mm)- Week 48 | 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 | Hemoglobin (g/dL)- Week 24 | 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 | 1 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 | Hemoglobin (g/dL)- Week 40 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/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 | Neutrophils (cells/cubic mm)- Week 8 | 1 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 | 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 40 | 2 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 16 | 1 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 | ALT (SGPT) (U/L)- 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 | Creatinine (mg/dL)- Week 16 | 3 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 56 | 1 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 24 | 3 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 | Creatinine (mg/dL)- Week 32 | 3 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 | Creatinine (mg/dL)- Week 40 | 7 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 | Creatinine (mg/dL)- Week 48 | 3 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 56 | 4 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 64 | 5 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 56 | 4 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 72 | 4 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 | WBC (1000/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 48 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000/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 32 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000/cubic mm)- Week 24 | 0 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 64 | 2 Participants |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000/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 24 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 56 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 8 | 1 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 16 | 4 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 24 | 2 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 32 | 1 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 40 | 1 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 48 | 1 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 56 | 3 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 64 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 72 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 8 | 2 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 | 2 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 | 6 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 48 | 1 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 56 | 2 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 64 | 2 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 72 | 2 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000/cubic mm)- Week 8 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000/cubic mm)- Week 16 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000/cubic mm)- Week 24 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000/cubic mm)- Week 32 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000/cubic mm)- Week 40 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000/cubic mm)- Week 48 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000/cubic mm)- Week 56 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000/cubic mm)- Week 64 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000/cubic mm)- Week 72 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/cubic mm)- Week 8 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/cubic mm)- Week 16 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/cubic mm)- Week 24 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/cubic mm)- Week 32 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/cubic mm)- Week 40 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/cubic mm)- Week 48 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/cubic mm)- Week 56 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/cubic mm)- Week 64 | 0 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/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 | 1 Participants |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 48 | 0 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 | 0 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/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 | 3 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/cubic mm)- Week 24 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000/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 | 7 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/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 | 6 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 16 | 4 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Lymphocytes (cells/cubic mm)- Week 40 | 1 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 64 | 7 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 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 48 | 4 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 40 | 13 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 48 | 1 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 | 8 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Creatinine (mg/dL)- Week 24 | 5 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 40 | 3 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 | 3 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 72 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 8 | 1 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 64 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Hemoglobin (g/dL)- Week 56 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 56 | 1 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 48 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | ALT (SGPT) (U/L)- Week 32 | 2 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Neutrophils (cells/cubic mm)- Week 16 | 1 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 | 4 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/cubic mm)- Week 48 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/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/cubic mm)- Week 56 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/cubic mm)- Week 32 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/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/cubic mm)- Week 64 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/cubic mm)- Week 16 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/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 | 3 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | Platelets (1000/cubic mm)- Week 72 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000/cubic mm)- Week 72 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000/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 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000/cubic mm)- Week 56 | 0 Participants |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above | WBC (1000/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 | 1 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/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 0 | 248.5 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 40 | 6.09 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 0 | 6.33 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 72 | 5.91 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 64 | 6.05 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 48 | 6.16 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 56 | 254 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 56 | 6.1 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 48 | 251 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 16 | 6.1 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 72 | 254 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 40 | 250.7 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 32 | 252 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 24 | 6.1 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 64 | 254 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 24 | 251.5 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 16 | 249.5 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 32 | 6.1 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 8 | 6.2 1000 cells/cubic mm |
| Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 8 | 248 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 64 | 256 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 0 | 6.4 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 8 | 6.1 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 16 | 6.1 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 24 | 6.15 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 32 | 6.1 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 40 | 6.09 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 48 | 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 | 6.04 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 64 | 5.9 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 72 | 5.92 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 0 | 248 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 8 | 250 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 16 | 252 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 24 | 250 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 32 | 253.5 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 40 | 254.5 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 48 | 256 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 56 | 256 1000 cells/cubic mm |
| Low-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 72 | 253 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 16 | 251 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 16 | 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 0 | 6.3 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 40 | 250 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 8 | 248 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 24 | 6.05 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 64 | 249 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 48 | 251 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 24 | 251 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 48 | 6 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 56 | 251 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 56 | 5.9 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 32 | 6.05 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 0 | 249 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 8 | 6.2 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 64 | 5.95 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 32 | 250 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 40 | 5.95 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 72 | 253 1000 cells/cubic mm |
| High-Dose VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 72 | 6.05 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 32 | 252 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 32 | 6.1 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 0 | 248.1 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 56 | 253 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 8 | 249 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 24 | 6.1 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 0 | 6.3 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 16 | 251 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 24 | 250.5 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 16 | 6.1 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 64 | 252 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 72 | 6 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 40 | 252 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 8 | 6.12 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 72 | 253 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 48 | 6 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000 cells/cubic mm)- Week 48 | 253 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 56 | 6 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 40 | 6 1000 cells/cubic mm |
| Pooled VRC01 | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000 cells/cubic mm)- Week 64 | 5.94 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 | 8.9 events per 100 person years |
| Low-Dose VRC01 | Incidence Rate of Early Infusion Discontinuation | 10 events per 100 person years |
| High-Dose VRC01 | Incidence Rate of Early Infusion Discontinuation | 8.8 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 | Induration/Swelling | Gr 3: >= 10cm | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 2: 5 to less than 10cm | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Missing | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Missing | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 1: 2.5 to less than 5cm | 7 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 896 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >= 10cm | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 5 to less than 10cm | 9 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 2: 5 to less than 10cm | 9 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 877 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 2.5 to less than 5cm | 20 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 874 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: >= 10cm | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 4: complications AE | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Missing | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 4: complications AE | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 4: complications AE | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 1: 2.5 to less than 5cm | 17 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 2: 5 to less than 10cm | 8 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 878 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 1: 2.5 to less than 5cm | 13 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: >= 10cm | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 4: complications AE | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Missing | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 894 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 1: 2.5 to less than 5cm | 4 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 2: 5 to less than 10cm | 1 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: >= 10cm | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 4: complications AE | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Missing | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 876 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 2.5 to less than 5cm | 15 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 5 to less than 10cm | 8 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >= 10cm | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 4: complications AE | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Missing | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 4: complications AE | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: >= 10cm | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 4: complications AE | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: >= 10cm | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Missing | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Missing | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 4: complications AE | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 880 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 2: 5 to less than 10cm | 2 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 2.5 to less than 5cm | 14 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 882 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 5 to less than 10cm | 3 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 1: 2.5 to less than 5cm | 13 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 894 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Missing | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 1: 2.5 to less than 5cm | 2 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >= 10cm | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 2: 5 to less than 10cm | 1 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 1788 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >= 10cm | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 2.5 to less than 5cm | 29 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: >= 10cm | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: >= 10cm | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 1760 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 1: 2.5 to less than 5cm | 26 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 4: complications AE | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 4: complications AE | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Missing | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 5 to less than 10cm | 11 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Missing | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 2: 5 to less than 10cm | 10 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Missing | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 2: 5 to less than 10cm | 2 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 1756 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 1: 2.5 to less than 5cm | 6 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 4: complications AE | 0 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 | 812 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Mild | 180 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 | 1 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 | 718 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 | 90 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 | 754 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Moderate | 5 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Mild | 145 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 | 4 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Moderate | 5 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Mild | 191 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 | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Mild | 104 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | None | 702 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Moderate | 6 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 | 1 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Mild | 153 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 | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | None | 741 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 | 794 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Moderate | 5 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | None | 805 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Mild | 88 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Moderate | 4 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Severe | 0 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 | 759 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Mild | 133 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Severe | 0 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 | 720 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Mild | 170 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Moderate | 7 Participants |
| High-Dose VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Severe | 0 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 | 286 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Mild | 192 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Mild | 361 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | None | 1500 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 | 1599 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Moderate | 13 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Severe | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Moderate | 5 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 | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Severe | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | None | 1422 Participants |
| Pooled VRC01 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Moderate | 10 Participants |
Primary
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, 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 | Headache | Mild | 146 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 | Myalgia | None | 809 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 889 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 28 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 556 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 197 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 3 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 1 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 4 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 | Arthralgia | 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 | Myalgia | Moderate | 13 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 | Moderate | 8 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 821 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 | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 664 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 74 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 | Arthralgia | Mild | 39 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 5 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 39 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | None | 880 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 286 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 41 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 728 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | Mild | 14 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 | Chills | None | 857 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 861 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | Moderate | 7 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 | Myalgia | Mild | 81 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 | Increased Body Temperature | Severe | 1 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 57 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 | Vomiting | Moderate | 2 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | Potentially Life-threatening | 1 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 3 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 12 Participants |
| Placebo | 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 | Headache | None | 714 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 | Max. Systemic Symptoms | None | 546 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 277 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 72 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 | Max. Systemic Symptoms | Severe | 4 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 | Malaise and/or fatigue | Moderate | 45 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | None | 879 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | Mild | 11 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 | Increased Body Temperature | Moderate | 7 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 | Increased Body Temperature | Potentially Life-threatening | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 147 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 35 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 3 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 | Headache | Potentially Life-threatening | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 814 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 74 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 10 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 | Nausea | Severe | 1 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 | Vomiting | None | 873 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 24 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 802 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 2 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 | Malaise and/or fatigue | Mild | 182 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 | Chills | None | 843 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 76 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 45 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 11 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 | Chills | Potentially Life-threatening | 0 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 21 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 848 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 44 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 672 Participants |
| Low-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 7 Participants |
| Low-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 | Chills | Potentially Life-threatening | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 4 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 820 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | Severe | 1 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 1 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 | Max. Systemic Symptoms | Mild | 273 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 731 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 | Vomiting | Potentially Life-threatening | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | Moderate | 12 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | Mild | 14 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 869 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 861 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 15 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | None | 870 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 563 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 29 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 61 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 | Arthralgia | Moderate | 7 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 6 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 77 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 812 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 | Mild | 169 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 8 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 | Potentially Life-threatening | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 21 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 | Malaise and/or fatigue | Potentially Life-threatening | 0 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 | Chills | Severe | 1 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 | Headache | Moderate | 29 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 691 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 2 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 881 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 137 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | Potentially Life-threatening | 0 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 59 Participants |
| High-Dose VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 12 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 | Malaise and/or fatigue | Moderate | 36 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 | Malaise and/or fatigue | None | 1363 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 351 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 81 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 | Potentially Life-threatening | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 1622 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 137 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 36 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 1 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 | Headache | None | 1445 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 284 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 64 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 3 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 | Nausea | None | 1626 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 151 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 18 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 1 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 | Vomiting | None | 1754 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 36 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 | Vomiting | Severe | 0 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 | Chills | None | 1704 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 74 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 | Severe | 1 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 | Arthralgia | None | 1717 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 65 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 14 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 | Arthralgia | Potentially Life-threatening | 0 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 1109 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 550 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 131 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 6 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 | Increased Body Temperature | None | 1749 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | Mild | 25 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | Moderate | 19 Participants |
| Pooled VRC01 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Increased Body Temperature | Severe | 3 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 | 38 Participants |
| Low-Dose VRC01 | Number of Participants With Documented HIV-1 Infection by the Week 80 Visit | 32 Participants |
| High-Dose VRC01 | Number of Participants With Documented HIV-1 Infection by the Week 80 Visit | 28 Participants |
| Pooled VRC01 | Number of Participants With Documented HIV-1 Infection by the Week 80 Visit | 60 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: 0.1595% CI: [-11.7, 51.8]wald
Comparison: A secondary analysis assesses the overall PE of the low-dose VRC01 group versus the placebo group.95% CI: [-25.5, 52]
Comparison: A secondary analysis assesses the overall PE of the high-dose VRC01 group versus the placebo group.95% CI: [-13.9, 58]
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 | 11 Participants |
| Placebo | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | No Discontinuation | 759 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 | 0 Participants |
| Placebo | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Two(2) reactive HIV tests | 0 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 | 14 Participants |
| Placebo | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | HIV infection | 37 Participants |
| Placebo | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Termination from study for non-medical reason(s) | 69 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 | 7 Participants |
| Placebo | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Participant refused study product infusion | 5 Participants |
| Low-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | HIV infection | 32 Participants |
| Low-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Participant refused study product infusion | 5 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 | 0 Participants |
| Low-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Other | 6 Participants |
| Low-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Co-enrollment in a study | 2 Participants |
| Low-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Pregnancy | 0 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 | 0 Participants |
| Low-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Death | 2 Participants |
| Low-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | No Discontinuation | 759 Participants |
| Low-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Termination from study for non-medical reason(s) | 75 Participants |
| High-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Co-enrollment in a study | 1 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 | 21 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 | 20 Participants |
| High-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Reactogenicity Symptom | 0 Participants |
| High-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Investigator Reason | 1 Participants |
| High-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Participant refused study product infusion | 7 Participants |
| High-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Two(2) reactive HIV tests | 3 Participants |
| High-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Other | 7 Participants |
| High-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Termination from study for non-medical reason(s) | 80 Participants |
| High-Dose VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | No Discontinuation | 757 Participants |
| Pooled VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Investigator Reason | 3 Participants |
| Pooled VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Reactogenicity Symptom | 0 Participants |
| Pooled VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Pregnancy | 0 Participants |
| Pooled VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Other | 13 Participants |
| Pooled VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Clinical event other than reactogenicity | 36 Participants |
| Pooled VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Death | 2 Participants |
| Pooled VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | No Discontinuation | 1516 Participants |
| Pooled VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Termination from study for non-medical reason(s) | 155 Participants |
| Pooled VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Co-enrollment in a study | 3 Participants |
| Pooled VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Participant refused study product infusion | 12 Participants |
| Pooled VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | HIV infection | 53 Participants |
| Pooled VRC01 | Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation | Two(2) reactive HIV tests | 3 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 | 23.1 μg/ml |
| Placebo | Serum Concentration of VRC01 in Participants Assigned to Receive the mAb | 8-week post infusion visit | 5.8 μg/ml |
| Placebo | Serum Concentration of VRC01 in Participants Assigned to Receive the mAb | Day 61 | 65.7 μg/ml |
| Low-Dose VRC01 | Serum Concentration of VRC01 in Participants Assigned to Receive the mAb | 4-week post infusion visit | 55.1 μg/ml |
| Low-Dose VRC01 | Serum Concentration of VRC01 in Participants Assigned to Receive the mAb | 8-week post infusion visit | 15.4 μg/ml |
| Low-Dose VRC01 | Serum Concentration of VRC01 in Participants Assigned to Receive the mAb | Day 61 | 212 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) | 3.28 μg/ml |
| Low-Dose VRC01 | VRC01 Clinical Lot Neutralization of Founder Viruses (IC80) | 4.7 μg/ml |
| High-Dose VRC01 | VRC01 Clinical Lot Neutralization of Founder Viruses (IC80) | 5.78 μg/ml |
| Pooled VRC01 | VRC01 Clinical Lot Neutralization of Founder Viruses (IC80) | 4.97 μg/ml |
Comparison: PE against IC80 of least sensitive variant less than 195% CI: [27.6, 89.9]
Comparison: PE against IC80 of least sensitive variant 1-395% CI: [-174.3, 67.8]
Comparison: PE against IC80 of least sensitive variant \> 395% CI: [-68.1, 50.3]
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 |