VRC 605: Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered Intravenously or Subcutaneously to Healthy Adults
Condition: HIV Prevention
Study type: Interventional
Phase: Phase 1

Summary: 
      Background:

      Human immunodeficiency virus (HIV) is a global health threat. The body uses antibodies to
      fight infection. VRC07-523LS is an antibody directed against HIV. It may be used to prevent
      mother-to-child transmission of HIV. It may also prevent sexual transmission of HIV and treat
      HIV-1 infected people.

      Objective:

      To test the safety, tolerability, dose, and pharmacokinetics of VRC07-523LS in healthy
      adults.

      Eligibility:

      Healthy people ages 18-50

      Design:

      Participants will be screened with:

      Medical history

      Physical exam

      Blood and urine tests

      Participants will be assigned to 1 of 7 groups:

      Groups 1-5 will get the drug at 1 visit and then be observed for 24 weeks.

      Groups 6 and 7 will get the drug at 1 visit every 12 weeks, for a total of 3 doses over 48
      weeks.

      Participants will get the drug in 1 of 2 ways:

      Infusion into a vein over at least 30 minutes. Participants will have blood tests 1, 3, and 6
      hours after the infusion. They will have 1-3 visits during that week. Those in Group 7 will
      have 4-5 visits in the week after their second and third doses.

      Injection into the fatty tissue under the skin. Participants will have blood tests before the
      injection. They will have 1-3 visits during that week. Those in Group 6 will have 4-5 visits
      after the second and third doses.

      Visits include:

      Physical exam

      Blood and urine tests

      Optional oral swabs to collect saliva

      Participants will keep a diary of their temperature and symptoms for 3 days after each dose.
    

Detailed description: 
      This is the first study of the VRC-HIVMAB075-00-AB (VRC07-523LS) monoclonal antibody (MAb) in
      healthy adults. It is a phase 1, dose-escalation study to examine safety, tolerability, dose,
      and pharmacokinetics of VRC07-523LS. The hypothesis is that VRC07-523LS will be safe for
      administration to healthy adults by the intravenous (IV) and subcutaneous (SC) routes.

      Healthy adults 18-50 years of age will be enrolled. There are 4 open-label, dose escalations
      of VRC07-523LS from 1 mg/kg IV to 40 mg/kg IV, 1 route escalation from IV to SC, and 2
      open-label groups to assess repeat dosing. Groups 1-5 are expected to include 3 subjects and
      Groups 6-7 are expected to enroll 5 subjects. Subjects will be followed for 24 weeks after
      the last study product administration.
    

Intervention name(s): VRC-HIVMAB075-00-AB
Intervention type(s): Biological
Intervention description(s): VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.
Other intervention name(s): VRC07-523LS
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Broadly Neutralizing; HIV Prevention; Anti-Drug Antibody; HIV-1; Immune Response