An HIV vaccine: As we build it, will they come? Good science is not enough. A promising vaccine without the volunteers to test it will impair its long-term success

Health Affairs

Volumn 24, Issue 3, 2005, Pages 643-651

  McCluskey, Margaret M ^a   Alexander, Sarah B ^b   Larkin, Brenda D ^c   Murguia, Matthew ^d   Wakefield, Steven ^e  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

^b Fred Hutchinson Cancer Research Center   (United States)

^c VRC ^*  (United States)

^d NIH Office of Program Operations and Scientific Information

^e HIV Vaccine Trials Network ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HUMAN IMMUNODEFICIENCY VIRUS VACCINE;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; CLINICAL TRIAL; DRUG MANUFACTURE; DRUG RESEARCH; ETHNOLOGY; FATIGUE; FEVER; HEADACHE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INJECTION SITE REACTION; MANAGEMENT; MEDICAL INFORMATICS; REVIEW; SEXUAL BEHAVIOR; VACCINATION; VACCINATION REACTION; VIRUS TRANSMISSION;

AIDS VACCINES; CLINICAL TRIALS; DRUG INDUSTRY; HIV INFECTIONS; HUMAN EXPERIMENTATION; HUMANS; POLICY MAKING; RESEARCH; UNITED STATES;

EID: 20044378527     PISSN: 02782715     EISSN: None     Source Type: Journal    
DOI: 10.1377/hlthaff.24.3.643     Document Type: Review

References (17)

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9. Catanzaro and Graham, "Rationale for Current HIV Clinical Trials."
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11. For a regularly updated database of HIV vaccine trials, see International AIDS Vaccine Initiative, "Ongoing Trials of Preventive HIV Vaccines," www.iavireport.org/trialsdb (25 January 2005). Phase I trials answer safety and immune-response questions and generally involve a small number of participants at low risk for infection. Phase I/II trials also answer these questions and involve a midsize group of low-risk participants. Phase II trials continue to address safety and immune-response questions while also evaluating optimal dosing. Phase II trials generally engage a midsize group of participants who are at moderate to high risk for infection. If a Phase II trial is successful, researchers move on to Phase III trials, which generally involve a large group of participants at high risk for infection. The goal of Phase III trials is to determine if the vaccine actually works.
12. Catanzaro and Graham, "Rationale for Current HIV Clinical Trials."
13. J.N. Blankson, D. Persaud, and R.F. Siliciano, "The Challenge of Viral Reservoirs in HIV-1 Infection," Annual Review of Medicine 53 (2002): 557-593.
14. Numbers polled were as follows: 2,000 general population, 500 African Americans, 500 Latinos, and 500 men who have sex with men. National Institute of Allergy and Infectious Diseases (NIAID), unpublished survey. December 2001-February 2002.
15. U.S. Centers for Disease Control and Prevention, HIV Surveillance Report, vol. 15 (Atlanta: CDC, December 2004).
16. National Institutes of Health, Fiscal Year 2004 Plan for HIV-Related Research, May 2002, www.nih.gov/od/oar/public/pubs/fy2004/i_overview.pdf (15 November 2004).
17. International AIDS Vaccine Initiative, "Developing and Delivering an AIDS Vaccine: Issues and Answers," July 2004, www.iavi.org/file.cfm?fid= 401 (22 February 2005).