The Vaccine Research Center (VRC) at the US National Institutes of Health was opened by Bill Clinton in 1997. Under the leadership of Dr. Gary Nabel, the VRC has rapidly become a major player in HIV vaccine development. The lead HIV vaccine candidates developed by VRC are based on two complementary platforms: naked DNA and an attenuated recombinant adenovirus serotype 5 (rAd5) vector. Plans to move these candidates into phase II trials were reported on the blog back in October 2005. The phase I trial results obtained with these HIV vaccines have now been published in the Journal of Infectious Diseases, and they're very encouraging. As Harriet Robinson and Kent Weinhold state in the accompanying commentary "the two articles for the DNA and rAd5 vaccines being developed by the VRC represent the first published reports of the elicitation of anti-HIV T cells in the vast majority of participants in a human trial." While similar results have been reported at meetings for the rAd5-based HIV vaccine developed by Merck (which is now in a phase IIb efficacy trial), these results have yet to be published. Previous to the development of the rAd5 vectors, no vaccine candidate had been able to reliably induce HIV-specific CD8 T cells in more than ~20-30% of study participants. A large 16,000-person efficacy trial of the VRC's HIV vaccine candidates is planned, and may start as early as next year.
The Journal of Infectious Diseases has made all the articles available free of charge:
Phase 1 Clinical Trials of the National Institutes of Health Vaccine Research Center HIV/AIDS Candidate Vaccines
Harriet L. Robinson and Kent J. Weinhold
Phase 1 Safety and Immunogenicity Evaluation of a Multiclade HIV-1 DNA Candidate Vaccine
Barney S. Graham, Richard A. Koup, Mario Roederer, Robert T. Bailer, Mary E. Enama, Zoe Moodie, Julie E. Martin, Margaret M. McCluskey, Bimal K. Chakrabarti, Laurie Lamoreaux, Charla A. Andrews, Phillip L. Gomez, John R. Mascola, Gary J. Nabel, and Vaccine Research Center 004 Study Team
Andrew T. Catanzaro, Richard A. Koup, Mario Roederer, Robert T. Bailer, Mary E. Enama, Zoe Moodie, Lin Gu, Julie E. Martin, Laura Novik, Bimal K. Chakrabarti, Bryan T. Butman, Jason G. D. Gall, C. Richter King, Charla A. Andrews, Rebecca Sheets, Phillip L. Gomez, John R. Mascola, Gary J. Nabel, Barney S. Graham, and Vaccine Research Center 006 Study Team