HPTN 027

A Phase I Study to Evaluate the Safety and Immunogenicity of ALVAC-HIV vCP1521 in Infants Born to HIV-1 Infected Women in Uganda

Study Summary

What was HPTN 027?

A Phase I, randomized, double blind, placebo-controlled trial to evaluate the safety and immunogenicity of ALVAC-HIV vCP1521 in infants born to HIV-1 infected women in Uganda

Who participated in the study?

50 fully evaluable infants (40 immunogen, 10 control) born to HIV-1 infected Ugandan women with CD4 counts > 500 cells/uL attending the antenatal clinics at Mulago Hospital in Kampala, Uganda

What happened during the study?

Eligible infants were randomized after birth to one of two study arms in a ratio of 4:1. Infants in Arm A were given the active study vaccine (ALVAC-HIV vCP1521), and infants in Arm B were given a placebo vaccine (sodium chloride injection USP, 0.9%). For infants in both study arms, the vaccine dose was given on or before Day 3 after birth, and at 4, 8 and 12 weeks postpartum.

Why was this study important?

At the time of this study there was an urgent need for alternative interventions that provided protection from HIV infection to infants during breastfeeding:

The majority of HIV-1 infected women reside in the developing world where breastfeeding is practiced nearly universally, often for 1 to 2 years after delivery. The impact of perinatal antiretroviral therapies may be diminished in breastfeeding populations with continual exposure of the infant to HIV-1 through breast milk. The high cost and difficult logistics of continuing antiretroviral therapy in the infant or mother for the duration of breast-feeding is likely to prohibit widespread and routine use in resource poor countries.

Study Documents