Broadening inclusion of vulnerable populations in HIV vaccine trials

Abstract

The urgent need for a preventive HIV vaccine, as well as the complexities of its development, calls for timely and reinforced efforts to ensure vaccine licensure for use in a broad range of at-risk populations from the outset. Such an integrated strategy to HIV vaccine development should include infants of HIV-infected women, adolescents and injection drug users. A safe and effective HIV vaccine licensed for use in these populations, in addition to sexually active adults, would probably have the most timely and profound impact on the HIV/AIDS pandemic. Advanced clinical development of HIV vaccines in these vulnerable populations imposes particular scientific, operational and ethical challenges. Recent developments, including the early termination of a Phase IIb trial, present additional previously unanticipated challenges.

Keywords::

• adolescents
• clinical trials
• HIV
• infants
• injection drug users
• vaccines

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Notes

HIV vaccine clinical trials being conducted by the NIAID Vaccine Research Center, the NIAID Division of AIDS and Networks supported by it (HIV Vaccine Trials Network, US Military HIV Research Program), or in collaboration with IAVI, the Thai Ministry of Health and various vaccine companies (Merck, Sanofi, Wyeth, Therion, Geovax, Alphavax, Pharmexa-Epimmune). Phase I/II trials listed were selected on the basis of their potential to move to advance development (i.e., Phase IIB or Phase III). As of January, 2008, 20 trials were underway.

Ad: Adenovirus; Gp: Glycoprotein; HVTN: HIV Vaccine Trials Network; IAVI: International AIDS Vaccine Initiative; MVA: Modified vaccinia Ankara; NCI: National Cancer Institute; RV: Retrovirus; SAAVI: South African AIDS vaccine initiative; VRC: Vaccine Research Center.