title: 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.
authors.affiliation: Vaccine Clinical Research Branch, Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, NIH, 6700 B Rockledge Drive, Room 5126, Bethesda, MD 20817, USA. lauc@niaid.nih.gov
authors.forename: Chuen-Yen
authors.initials: CY
authors.lastname: Lau
authors.forename: Massimo
authors.initials: M
authors.lastname: Cardinali
authors.forename: Paul A
authors.initials: PA
authors.lastname: Sato
authors.forename: Alan
authors.initials: A
authors.lastname: Fix
authors.forename: Jorge
authors.initials: J
authors.lastname: Flores
mesh_terms: D016915:AIDS Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D000818:Animals; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D005260:Female; D015658:HIV Infections / Q000517:prevention & control* / Q000635:transmission / Q000821:virology; D015497:HIV-1 / Q000276:immunology; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000517:prevention & control / Q000821:virology; D012307:Risk Factors; D015819:Substance Abuse, Intravenous / Q000150:complications; D035862:Vulnerable Populations
chemical_list: D016915:AIDS Vaccines