RESEARCHERS TO STUDY PEDIATRIC HIV VACCINE

Researchers at Makerere University in Uganda, along with scientists from Johns Hopkins University and other institutions, have begun the first clinical trial in Africa of a vaccine to prevent mother-to-child transmission of HIV through breastfeeding. Breast milk is a leading route of infection in the developing world, according to the World Health Organization, which estimates that each day 1,800 newborns are infected with HIV, 30 percent to 40 percent via their mother's milk.

Enrollment of the first newborn took place at Mulago Hospital in Kampala, Uganda. The Phase I study is designed to test the safety of injecting newborns with the vaccine, formally known as ALVAC-HIV (vCP1521). If the vaccine is found to be safe, and if it is later shown to be effective in reducing the chance of infants becoming infected during breastfeeding, researchers estimate that it could potentially stop up to 8,000 of Uganda's 22,000 infections in children each year. Initial results are expected by mid-2007.

The Ugandan-led study will involve 50 infants born to HIV-positive mothers, all of whom are otherwise in general good health, with key immune CD4 cell counts of 500 cells per cubic mL of blood or greater. Forty infants will be randomly assigned to receive the vaccine while 10 others will get placebo. Once enrolled, infants will be injected in four separate doses of 1 mL of vaccine each over a period of three months. Participants will then be closely monitored through regular physical examinations and blood tests for the duration of the study, which is expected to last two and a half years.

The aim of the Johns Hopkins team is to eventually find a vaccine that will allow infants to develop immunity to HIV just as they would to polio, diphtheria and hepatitis B. The goal is to one day provide an HIV vaccine as part of a child's regular immunization program.