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Phase 1 N=80 Randomized Prevention

Evaluating the Safety, Pharmacokinetics, and Anti-Viral Activity of VRC01 and VRC01LS in the Serum and Mucosa of Healthy, HIV-Uninfected Adults

HIV Infections

Bottom Line

View on ClinicalTrials.gov: NCT02797171 ↗
Enrolled (actual)
80
Serious AEs
3.8%
Results posted
Jan 2021
Primary outcome: Primary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms — 19; 18; 7; 15 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
VRC01 (Biological); VRC01LS (Biological)
Age
Adult · 18+ yrs
Sex
All
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion
Jun 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants Reporting Local Reactogenicity Signs and Symptoms		 19; 18; 7; 15; 10; 4 —
PRIMARY
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms		 14; 18; 6; 12; 9; 7 —
PRIMARY
Chemistry and Hematology Laboratory Measures		 16; 16; 17; 15.5; 13; 33 —
PRIMARY
Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin		 14.5; 14; 13.7; 14.75; 13.3; 14.9 —
PRIMARY
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)		 6.37; 7.14; 8.31; 5.85; 6.45; 9.02 —
PRIMARY
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1		 0; 0; 0; 0; 0; 0 —
PRIMARY
Number of Participants Reporting Adverse Events (AEs)		 5; 3; 0; 2; 1; 1 —
PRIMARY
Number of Participants Reporting Serious Adverse Events (SAEs)		 0; 1; 1; 0; 1; 0 —
PRIMARY
Rates of Participant Discontinuation		 1; 0; 0; 0; 0; 0 —
PRIMARY
Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)		 0.02; 0.02; 0.02; 0.02; 0.05; 0.05 —
PRIMARY
IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)		 0; 0; 0; 0; 0; 0.01 —
PRIMARY
Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)		 0; 0; 0; 0; 0; 0 —
PRIMARY
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)		 0; 0; 0.9; 0.26; 0.03; 0.01 —
PRIMARY
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)		 0.06; 0.02; 25.6; 7.53; 0.99; 0.52 —
PRIMARY
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)		 0; 0; 1.12; 0.24; 0.04; 0.02 —
SECONDARY
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)		 134.61; 128.69; 125.66; 81.74; 80.03; 82.33 —

Summary

This study will evaluate the safety, pharmacokinetics, and antiviral activity of VRC-HIVMAB060-00-AB (VRC01) and VRC-HIVMAB080-00-AB (VRC01LS) in the serum and mucosa of healthy, HIV-uninfected adults.

Eligibility Criteria

Inclusion Criteria

General and Demographic Criteria:

  • Age of 18 to 50 years
  • Weight less than or equal to 115 kg
  • 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; completes a questionnaire prior to enrollment 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 study 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 [low risk guidelines are found on the protocol home page on the HVTN Members' site (https://members.hvtn.org/protocols/hvtn116)] and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit

Laboratory Inclusion Values:

Hemogram/CBC

  • Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were born female, greater than or equal to 13.0 g/dL for volunteers who were born male
  • White blood cell count equal to 2,500 to 12,000 cells/mm^3
  • Total lymphocyte count greater than or equal to 800 cells/mm^3
  • Remaining 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), aspartate aminotransferase (AST), and alkaline phosphatase less than 1.25 times the institutional upper limit of normal; creatinine less than or equal to institutional upper limit of normal

Virology

  • Negative HIV-1 and -2 blood test: U.S. volunteers must have a negative Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA). Non-U.S. sites may use locally available assays that have been approved by HVTN 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

  • Normal urine:
  • Negative urine glucose, and
  • Negative or trace urine protein, and
  • Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a microscopic urinalysis with red blood cells levels within institutional normal range)

Reproductive Status:

  • Volunteers who were born female: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to initial biopsy for groups 1-3 and prior to initial infusion for groups 4-5 on the day of enrollment. Persons who are NOT of reproductive potential due to having undergone bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing.

Reproductive Status:

United States:

A volunteer who was born female must:

  • Agree to consistently use effective contraception (see the 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 116 Protocol Safety Review Team (PSRT)
  • Successful vasectomy in the male partner (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 postvasecto
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02797171). 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.

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