A Phase 1 Trial to Evaluate CAP256V2LS in Healthy Adults
Condition: HIV
Intervention: VRC-HIVMAB0102-00-AB
Intervention description: 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.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HIV Prevention; Broadly-Neutralizing Human Monoclonal Antibodies; First in Human; Anti-Drug Antibody Response; Antibodies

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.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

        A volunteer must have met all of the following criteria to be included:

          1. Able and willing to complete the informed consent process

          2. Able to provide proof of identity to the satisfaction of the study clinician
             completing the enrollment process

          3. Available for clinical follow-up through the last study visit

          4. 18 to 60 years of age

          5. Based on medical history and physical examination, in good health and without
             clinically significant findings within 84 days prior to enrollment.

          6. Weight less than or equal to 115 kg

          7. Willing to have blood samples collected, stored indefinitely, and used for research
             purposes

             Laboratory Criteria within 84 days prior to enrollment:

          8. White Blood Cell (WBC) 2,500-12,000/mm^3

          9. WBC differential either within institutional normal range or accompanied by the
             Principal Investigator (PI) or designee approval

         10. Platelets = 125,000-500,000/mm^3

         11. Hemoglobin within institutional normal range or accompanied by the PI or designee
             approval

         12. Creatinine less than or equal to 1.1 x upper limit of normal (ULN) based on the
             institutional normal range

         13. Alanine aminotransferase (ALT) less than or equal to 1.25 x ULN based on the
             institutional normal range

         14. Negative for HIV infection by an FDA approved method of detection

             Criteria Specific to Women of Childbearing Potential:

         15. Negative beta-human chorionic gonadotropin (HCG) pregnancy test (urine or serum) on
             day of enrollment, and prior to product administration

         16. Agrees to use an effective means of birth control from at least 21 days prior to
             enrollment through the duration of study participation

        EXCLUSION CRITERIA:

        A volunteer was excluded if one or more of the following conditions applied:

          1. Woman who is breast-feeding or planning to become pregnant during study participation

          2. Any history of a severe allergic reaction with generalized urticaria, angioedema or
             anaphylaxis prior to enrollment that has a reasonable risk of recurrence during the
             study

          3. Hypertension that is not well controlled

          4. Receipt of any investigational study product within 28 days prior to enrollment. Note:
             SARS-CoV-2 vaccines approved by emergency use authorization are not exclusionary.

          5. Receipt of any live attenuated vaccines within 28 days prior to enrollment.

          6. Receipt of any vaccine within 2 weeks prior to enrollment/product administration

          7. Prior receipt of a licensed or investigational monoclonal antibody

          8. Prior receipt of an HIV vaccine

          9. Any medical, psychiatric, social condition, occupational reason or other
             responsibility that, in the judgment of the investigator, is a contraindication to
             protocol participation or impairs a participant's ability to give informed consent.