Lau Chuen-Yen, Cardinali Massimo, Sato Paul A, Fix Alan, Flores Jorge
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.
Expert Rev Vaccines. 2008 Mar;7(2):259-68. doi: 10.1586/14760584.7.2.259.
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.
对预防性艾滋病毒疫苗的迫切需求及其研发的复杂性，要求及时加大力度，以确保从一开始就为广泛的高危人群发放疫苗使用许可。这种艾滋病毒疫苗研发的综合战略应包括感染艾滋病毒妇女的婴儿、青少年和注射吸毒者。一种经许可用于这些人群以及性活跃成年人的安全有效的艾滋病毒疫苗，可能会对艾滋病毒/艾滋病大流行产生最及时、最深远的影响。在这些脆弱人群中开展艾滋病毒疫苗的高级临床研发带来了特殊的科学、操作和伦理挑战。最近的进展，包括一项IIb期试验的提前终止，带来了更多先前未曾预料到的挑战。
