Phase 1
N=124
Evaluating the Safety and Serum Concentrations of a Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered in Multiple Doses and Routes to Healthy, HIV-uninfected Adults
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT03387150 ↗Enrolled (actual)
124
Serious AEs
2.4%
Results posted
Mar 2022
Primary outcome: Primary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness — 12; 11; 15; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- VRC07-523LS (Biological); Placebo (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness |
12; 11; 15; 8; 5; 7 | — |
| PRIMARY Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration |
14; 15; 16; 7; 7; 19 | — |
| PRIMARY Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms |
10; 10; 7; 12; 13; 14 | — |
| PRIMARY Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) |
16; 16; 16; 14; 18; 13 | — |
| PRIMARY Chemistry and Hematology Laboratory Measures - Creatinine |
0.85; 0.92; 0.84; 0.79; 0.84; 0.86 | — |
| PRIMARY Chemistry and Hematology Laboratory Measures - Hemoglobin |
13.3; 14.2; 13.8; 13.1; 13.8; 14.4 | — |
| PRIMARY Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count |
3.84; 3.7; 3.72; 3.24; 3.76; 2.82 | — |
| PRIMARY Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) |
6.4; 6.15; 6.8; 6.06; 6.7; 5.9 | — |
| PRIMARY Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY VRC07523LS Serum Concentrations |
0.5; 0.5; 0.5; 0.5; 0.5; 0.5 | — |
| SECONDARY Occurrence of Antidrug Antibodies (ADA) |
2; 2; 0; 2; 0; 1 | — |
| SECONDARY Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. |
1.56; 1.89; 2.46; 1.34; 1.54; 1.39 | — |
Summary
The purpose of this study is to evaluate the safety, tolerability, and serum concentrations of a human monoclonal antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), administered in multiple doses and routes to healthy, HIV-uninfected adults.
Eligibility Criteria
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 study product administration with verbal demonstration of understanding of all questionnaire items answered incorrectly
- Agrees not to enroll in another study of an investigational research agent until completion of the last required protocol clinic visit
- Good general health as shown by medical history, physical exam, and screening laboratory tests
HIV-Related Criteria:
- Willingness to receive HIV test results
- Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling.
- Assessed by the clinic staff as being at 'low risk' for HIV infection and committed to maintaining behavior consistent with those criteria through the last required protocol clinic visit (see the protocol for more information).
Laboratory Inclusion Values
Hemogram/Complete Blood Count (CBC)
- Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were assigned female sex at birth, greater than or equal to 13.0 g/dL for volunteers who were assigned male sex at birth. For transgender participants who have been on hormone therapy for more than 6 consecutive months, determine hemoglobin eligibility based on the gender with which they identify (ie, a transgender female who has been on hormone therapy for more than 6 consecutive months should be assessed for eligibility using the hemoglobin parameters for volunteers assigned female sex at birth).
- White blood cell (WBC) count equal to 2,500 to 12,000 cells/mm^3
- WBC differential either within institutional normal range or with site physician approval
- Platelets equal to 125,000 to 550,000/mm^3
Chemistry
- Chemistry panel: Alanine aminotransferase (ALT) less than 1.25 times the institutional upper limit of normal and creatinine less than or equal to institutional upper limits of normal.
Virology
- Negative HIV-1 and -2 blood test: US volunteers must have a negative US Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA). Non-US sites may use locally available assays that have been approved by HVTN and HIV Prevention Trials Network (HPTN) Laboratory Operations.
- Negative Hepatitis B surface antigen (HBsAg)
- Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive
Urine
- Negative or trace urine protein
Reproductive Status
- Volunteers who were assigned female sex at birth: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to study product administration on the day of initial study infusion/injection. Persons who are NOT of reproductive potential 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 was assigned female sex at birth must:
- Agree to use effective contraception (see protocol for more information) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit. Effective contraception is defined as using the following methods:
- Condoms (male or female) with or without a spermicide,
- Diaphragm or cervical cap with spermicide,
- Intrauterine device (IUD),
- Hormonal contraception, or
- Any other contraceptive method approved by the HVTN 127/HPTN 087 Protocol Safety Review Team (PSRT)
- Successful vasectomy in any partner assigned male sex at birth (considered successful if a volunteer reports that a partner assigned male sex at birth has [1] documentation of azoospermia by
Data sourced from ClinicalTrials.gov (NCT03387150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.