A Phase 1 Trial to Evaluate CAP256V2LS in Healthy Adults
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      Background:

      HIV is a serious disease with no cure or vaccine to prevent it. Using antibodies could be a
      way to prevent HIV infection. Antibodies are made by the human body to fight germs.
      Researchers want to test an antibody, CAP256V2LS.

      Objective:

      To test CAP256V2LS to see if it is safe and how the body responds to it.

      Eligibility:

      Healthy people, ages 18-60

      Design:

      Participants were screened with a medical history, physical exam, and blood tests. Some
      females had a pregnancy test.

      Participants were assigned to one of two groups. Based on their group, they got 1 dose of
      CAP256V2LS in 1 of 2 ways:

        -  Some participants got CAP256V2LS as an infusion. A thin tube was placed in an arm vein
           and CAP256V2LS was given into the vein using a pump.

        -  Some participants got CAP256V2LS injected under the skin. A small needle was used to
           inject CAP256V2LS into the fatty tissue of the belly, arm, or thigh. They got 1 to 4
           injections.

      On the day they got CAP256V2LS, participants gave blood samples at different time points.

      Participants were asked to check their temperature every day for 7 days after receiving
      CAP256V2LS. They used a tool to measure any redness, swelling, or bruising they may have at
      the site where they received the study drug.

      Participants had visits at least 2-3 times during the first week after they got CAP256V2LS.
      Then they had about 9 more visits over the next 6 months. Visits included blood tests.
    

Detailed description: 
      Design:

      This open-label study evaluated CAP256V2LS (VRC-HIVMAB0102-00-AB) in healthy adults. The
      primary hypothesis was that subcutaneous (SC) and intravenous (IV) administrations of
      CAP256V2LS will be safe and well-tolerated in healthy adults. A secondary hypothesis was that
      CAP256V2LS will be detectable in human sera with a definable half-life.

      Study Product:

      The CAP256V2LS broadly neutralizing monoclonal antibody (bNAb) targets the V1V2 region of the
      HIV-1 envelope, is human in origin, and contains two amino acid modifications within the
      C-terminus of the heavy chain constant region designed to improve antibody half-life in vivo.
      This bNAb was developed by the VRC/NIAID/NIH in collaboration with The Centre for the AIDS
      Programme of Research in South Africa (CAPRISA) and is manufactured under current Good
      Manufacturing Practice (cGMP) regulations at the VRC Pilot Plant operated under contract by
      the Vaccine Clinical Materials Program (VCMP), Leidos Biomedical Research, Inc., Frederick.
      MD. The CAP256V2LS drug product is supplied at a concentration of 100 mg/mL in a sterile,
      aqueous, buffered solution of 6.25 mL in single-use 10 mL glass vials. R-Gene10 was added as
      a stabilizing agent to IV doses of CAP256V2LS. R-Gene10 (Arginine Hydrochloride Injection,
      USP) for intravenous infusion contains L-Arginine Hydrochloride, USP in Water for Injection
      (equivalent to a 10% solution).

      Participants:

      Healthy participants, 18-60 years of age

      Study Plan:

      This open-label study included 2 dosing regimens with CAP256V2LS administered at 5 mg/kg IV
      and 5 mg/kg SC. A single dose of the study product was administered on Day 0 as shown below.

      VRC 611 Study Design

        -  Group 1

             -  Study Product: CAP256V2LS

             -  Participants per Group: 5

             -  Dose (mg/kg) and Route Administered on Day 0: 5 mg/kg IV

        -  Group 2

             -  Study Product: CAP256V2LS

             -  Participants per Group: 5

             -  Dose (mg/kg) and Route Administered on Day 0: 5 mg/kg SC

      Total Participants: 10

      Duration:

      Study participation was approximately 24 weeks from the Day 0 product administration.
    

Intervention name(s): VRC-HIVMAB0102-00-AB
Intervention type(s): Biological
Intervention description(s): The VRC-HIVMAB0102-00-AB (CAP256V2LS) broadly neutralizing monoclonal antibody (bNAb) targets the V1V2 region of the HIV-1 envelope, is human in origin, and contains two amino acid modifications within the C-terminus of the heavy chain constant region designed to improve antibody half-life in vivo.
Other intervention name(s): CAP256V2LS
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV Prevention; Broadly-Neutralizing Human Monoclonal Antibodies; First in Human; Anti-Drug Antibody Response; Antibodies