Recent trends in clinical trials of vaccines to prevent HIV/AIDS.
OBJECTIVE
The aim of this article is to describe progress in research and development of vaccines to prevent HIV/AIDS, emphasizing clinical trials and human studies published during the past year.


RESULTS
Clinical trial design depends, in large part, on whether vaccines are expected to provide protection against HIV infection or mitigation such as slowing progression of disease or reducing transmissibility. There is currently no vaccine candidate in clinical trials that induces robust neutralizing antibodies. Vaccine candidates designed to induce cell-mediated immunity are now entering test-of-concept trials to guide decisions about whether to conduct larger-scale pivotal efficacy trials and if so how to select appropriate populations and endpoints. The mucosal immune system is an important target, both as a barrier to mucosal infection and as a site of early viral replication, but how to approach mucosal immunization is still not well understood. Candidate vaccines include peptides, proteins, plasmids, vectored vaccines and combinations thereof. Clinical trials of AIDS vaccine candidates are feasible but challenging, in both developed and developing countries. To educate and care for volunteers and obtain support from communities for clinical trials will be challenging, more so once a vaccine is approved for marketing. Coordination with research into other preventive methods is highly desirable.


CONCLUSIONS
A balance between basic, applied, and social research will be needed for successful development of preventive AIDS vaccines.
Fast
Patricia E
PE
International AIDS Vaccine Initiative, Medical Affairs, Research and Development, New York, New York 10038-3901, USA. pfast@iavi.org