Trial sites in Kenya and Rwanda expand recruitment

The projected number of individuals participating in a Phase I AIDS vaccine trial in Kenya and Rwanda, conducted by IAVI in partnership with the VRC, will be increased after approval was granted recently from the local institutional review boards in the countries. Project San Francisco began enrolling volunteers at the site in Kigali, Rwanda late last year—marking the start of the first AIDS vaccine trial in the country—and the Kenya AIDS Vaccine Initiative (KAVI) at the University of Nairobi began recruitment in January. Total enrollment for both sites was initially set at 64 volunteers but will now be increased to 104.

This trial is one of three closely coordinated trials testing the safety and immunogenicity of a "prime-boost" vaccination regimen with the VRC's DNA plasmid and adenovirus serotype 5 (Ad5) vaccine candidates (see Spotlight, this issue).

Other developments in Kenya include the opening of two new community clinics in Kilifi by the Kenya Medical Research Institute (KEMRI), with support from IAVI. One of these clinics, the Comprehensive Care and Research Clinic, will offer HIV testing and counseling services that can help facilitate future AIDS vaccine trials in the country, as well as house a clinical trials laboratory. Part of this building has also been reserved for provision of HIV treatment and care through the District Hospital, including a program for the prevention of mother-to-child transmission that tests over 4000 pregnant women each year.

The other newly-established clinic will focus mainly on couples voluntary counseling and testing that can help identify individuals in serodiscordant relationships, where one partner is HIV infected and the other is not. This type of counseling will help identify HIV-uninfected individuals who are therefore at high risk for HIV infection within their marriage or partnership and can possibly be volunteers for future AIDS vaccine trials (see VAX October 2005 Primeron Understanding Couples Voluntary Counseling and Testing). Couples counseling is an established practice at sites in Rwanda and Zambia, but this clinic is one of only a few to utilize this approach in Kenya.

KEMRI also opened a new drop-in center and clinic in Mtwapa for HIV-uninfected individuals who are at high risk for HIV infection. Over 300 uninfected volunteers have already been enrolled in a study to help promote an understanding of HIV infection and identify ways they can lower their risk. Collaborators from the University of Washington will treat volunteers for sexually-transmitted diseases, including offering antiretroviral (ARV) treatment to those who become infected with HIV from exposure in their community during the course of the study.