Evaluating the Safety and Pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to assess the safety and pharmacokinetics (PK) of three
      monoclonal antibodies, VRC01, VRC01LS, and VRC07-523LS, in HIV-exposed infants who are at
      increased risk of mother-to-child HIV transmission.
    

Detailed description: 
      VRC01, VRC01LS, and VRC07-523LS are anti-HIV neutralizing monoclonal antibodies that may help
      prevent mother-to-child transmission of HIV. This study enrolled HIV-infected mothers who
      were at increased risk of passing HIV on to their children. The purpose of this study was to
      assess the safety and PK of VRC01, VRC01LS, and VRC07-523LS in HIV-exposed infants.

      This study enrolled mother-infant pairs into five dose groups. Infants enrolled in Dose Group
      1 and Dose Group 2 received a single VRC01 injection less than 72 hours after birth. Infants
      in Dose Group 3 received a VRC01 injection less than 5 days after birth, followed by VRC01
      injections monthly for at least 6 months and no more than 18 months, while breastfeeding.

      Dose Groups 4 and 5 each enrolled infants into two cohorts: Cohort 1 (non-breastfeeding) or
      Cohort 2 (breastfeeding). Infants in Dose Group 4, Cohort 1 received a single VRC01LS
      injection less than 72 hours after birth. Infants in Dose Group 4, Cohort 2 received an
      initial VRC01LS injection no longer than 5 days after birth, and a second VRC01LS injection
      at Week 12 if they were still breastfeeding. Infants in Dose Group 5, Cohort 1 received a
      single VRC07-523LS injection less than 72 hours after birth. Infants in Dose Group 5, Cohort
      2 received an initial VRC07-523LS injection no longer than 5 days after birth, and a second
      VRC07-523LS injection at Week 12 if they were still breastfeeding.

      The mothers did not receive any VRC01, VRC01LS, or VRC07-523LS injections. At study entry,
      all mothers underwent a medical history review and a blood collection, and then the study
      ended for the mothers.

      Infants in Dose Groups 1 and 2 attended study visits at days 0, 1, 3, 7, 14, 28 and at weeks
      8, 16, 24, and 48. Infants in Dose Group 3 attended study visits at days 0, 1, 14, 28 and at
      weeks 8, 12, 16, 20, 24, and every 4 weeks until cessation of breastfeeding or week 72, then
      at weeks 84 and 96. Infants in Dose Group 4 attended study visits at days 0, 1, 14, 28 and at
      weeks 8, 12, 24, 36, 48, 60, 72, 84 and 96, with additional visits at weeks 14 and 16 for
      Cohort 2 participants. Infants in Dose Group 5 attended study visits at days 0, 1, 3, 7, 14,
      28 and at weeks 8, 12, 24, 36, 48, 60, 72, 84 and 96, with additional visits at weeks 14 and
      16 for Cohort 2 participants. Visits included a medical history review, physical examination,
      blood collection, and oral fluid collection.
    

Intervention name(s): VRC01; VRC01LS; VRC07-523LS
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Administered by subcutaneous injection in the thigh; Administered by subcutaneous injection in the thigh; Administered by subcutaneous injection in the thigh
Other intervention name(s): VRC-HIVMAB-060-00-AB; VRC01 mAb; VRC-HIVMAB080-00-AB; VRC-HIVMAB075-00-AB
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention