Phase 1
Completed N=28
Evaluating the Safety and Pharmacokinetics of VRC07-523LS in the Sera and Mucosae of Healthy, HIV-Uninfected Adult Participants
Source: ClinicalTrials.gov NCT03735849 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcomePrimary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms — 5; 10; 6; 3 Participants
Summary
The purpose of this study is to evaluate the safety and pharmacokinetics of a human monoclonal antibody (VRC07-523LS) in the sera and mucosae of healthy, HIV-uninfected adults.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Local Reactogenicity Signs and Symptoms |
5; 10; 6; 3; 0; 0 | — |
| PRIMARY Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms |
3; 4; 6; 5; 2; 3 | — |
| PRIMARY Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L |
19.0; 16.0; 14.0; 16.0; 22.0; 17.0 | — |
| PRIMARY Chemistry and Hematology Laboratory Measures- Hemoglobin and Creatinine (g/dl) |
14.3; 13.9; 13.4; 13.2; 13.9; 14.0 | — |
| PRIMARY Chemistry and Hematology Laboratory Measures- Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) |
8.03; 7.12; 6.22; 7.12; 7.63; 5.55 | — |
| PRIMARY Chemistry and Hematology Laboratory Measures |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants Reporting Adverse Events (AEs) |
1; 4; 9; 6; 0; 2 | — |
| PRIMARY Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation |
0; 2; 1; 0; 10; 11 | — |
| PRIMARY Unnormalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints |
1153.16; 1153.16; 70184.27; 178305; 57049.38; 175382.4 | — |
| PRIMARY IgG-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints |
0.062; 0.047; 3.92; 8.28; 5.52; 11.56 | — |
| PRIMARY Protein-normalized Levels of VRC07-523LS in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues at the Collection Timepoints |
0.0024; 0.0018; 0.12; 0.32; 0.16; 0.36 | — |
| PRIMARY Unnormalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration |
0.02; 0.02; 100.34; 220.14; 19.23; 44.32 | — |
| PRIMARY IgG-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration |
0.002; 0.002; 8.61; 18.9; 1.65; 3.8 | — |
| PRIMARY Protein-normalized Levels of VRC07-523LS in Serum Out to Week 48, 16 Weeks After the Last Product Administration |
0.00022; 0.00026; 0.97; 2.32; 0.19; 0.45 | — |
| SECONDARY Serum Concentration of ADA in Each Group Measured at Multiple Timepoints From Baseline Through the Final Study Visit |
15; 54; 15; 27 | — |
Eligibility Criteria
Inclusion Criteria
General and Demographic Criteria
- Age of 18 to 50 years
- Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (CRS) and willingness to be followed for the planned duration of the study
- Ability and willingness to provide informed consent
- Assessment of understanding: volunteer demonstrates understanding of this study and completes a questionnaire prior to first study product administration with verbal demonstration of understanding of all questionnaire items answered incorrectly
- Agrees not to enroll in another study of an investigational research agent until completion of the last required protocol clinic visit
- Good general health as shown by medical history, physical exam, and screening laboratory tests
HIV-Related Criteria:
- Willingness to receive HIV test results
- Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling.
- Assessed by the clinic staff as being at "low risk" for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit. See the study protocol for US Low risk guidelines.
Laboratory Inclusion Values
Hemogram/Complete blood count (CBC)
- Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were assigned female sex at birth, greater than or equal to 13.0 g/dL for volunteers who were assigned male sex at birth. For transgender participants who have been on hormone therapy for more than 6 consecutive months, determine hemoglobin eligibility based on the gender with which they identify (ie, a transgender female who has been on feminizing hormone therapy for more than 6 consecutive months should be assessed for eligibility using the hemoglobin parameters for persons assigned female sex at birth).
- White blood cell (WBC) count equal to 2,500 to 12,000 cells/mm^3
- WBC differential either within institutional normal range or with site physician approval
- Platelets equal to 125,000 to 550,000/mm^3
Chemistry
- Chemistry panel: Alanine aminotransferase (ALT) less than 1.25 times the institutional upper limit of normal and creatinine less than or equal to institutional upper limits of normal.
Virology
- Negative HIV-1 and -2 blood test: US volunteers must have a negative US Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA).
- Negative Hepatitis B surface antigen (HBsAg)
- Negative anti-Hepatitis C virus (anti-HCV) antibodies, or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive
Urine
- Normal urine:
- Negative or trace urine protein
Reproductive Status
- Volunteers who were assigned female sex at birth: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to biopsy collection and/or study product administration.
- Reproductive status: A volunteer who was assigned female sex at birth must:
- Agree to use effective contraception for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit. Effective contraception is defined as using the following methods:
- Condoms (male or female) with or without a spermicide,
- Diaphragm or cervical cap with spermicide,
- Intrauterine device (IUD),
- Hormonal contraception, or
- Any other contraceptive method approved by the HVTN 128 Protocol Safety Review Team (PSRT)
- Successful vasectomy in any partner assigned male sex at birth (considered successful if a volunteer reports that a male partner has [1] documentation of azoospermia by microscopy, or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy);
- Tubal ligation
- Or be sexually abstinent until at least 4 months following the last study product administration.
- Volunteers who were assigned female sex at birth must also agree not to seek pregnancy through alternat
Data sourced from ClinicalTrials.gov (NCT03735849). 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. Informational only — not medical advice.