Last updated on July 2019

Evaluating the Safety and Pharmacokinetics of VRC01 VRC01LS and VRC07-523LS Potent Anti-HIV Neutralizing Monoclonal Antibodies in HIV-1-Exposed Infants


Brief description of study

The purpose of this study is 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 Study Description

VRC01, VRC01LS, and VRC07-523LS are anti-HIV neutralizing monoclonal antibodies that may help prevent mother-to-child transmission of HIV. This study will enroll HIV-infected mothers who are at increased risk of passing HIV on to their children. The purpose of this study is to assess the safety and PK of VRC01, VRC01LS, and VRC07-523LS in HIV-exposed infants.

This study will enroll mother-infant pairs into five groups. Infants enrolled in Dose Group 1 and Dose Group 2 will receive a single VRC01 injection less than 72 hours after birth. Infants in Dose Group 3 will receive a VRC01 injection less than 5 days after birth. They will then receive additional VRC01 injections monthly for at least 6 months and no more than 18 months while breastfeeding.

Dose Groups 4 and 5 will each enroll infants into two cohorts: Cohort 1 (non-breastfeeding) or Cohort 2 (breastfeeding). Infants in Dose Group 4, Cohort 1 will receive a single VRC01LS injection less than 72 hours after birth. Infants in Dose Group 4, Cohort 2 will receive an initial VRC01LS injection no longer than 5 days after birth, and a second VRC01LS injection at Week 12 if they are still breastfeeding. Infants in Dose Group 5, Cohort 1 will receive a single VRC07-523LS injection less than 72 hours after birth. Infants in Dose Group 5, Cohort 2 will receive an initial VRC07-523LS injection no longer than 5 days after birth, and a second VRC07-523LS injection at Week 12 if they are still breastfeeding.

The mothers will not receive any VRC01, VRC01LS, or VRC07-523LS injections. At study entry, all mothers will undergo a medical history review and a blood collection. Infants in Dose Groups 1 and 2 will attend several study visits through Week 48. Infants in Dose Group 3, 4, and 5 will attend several study visits through Week 96. Visits will include a medical history review, physical examination, blood collection, and oral fluid collection.

Clinical Study Identifier: NCT02256631

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Tygerberg, South Africa
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