Negative social impacts among volunteers in an HIV vaccine efficacy trial

Journal of Acquired Immune Deficiency Syndromes

Volumn 46, Issue 3, 2007, Pages 362-368

  Fuchs, Jonathan ^a,b,e   Durham, Marcus ^c   McLellan Lemal, Eleanor ^c   Vittinghoff, Eric ^b   Colfax, Grant ^a,b   Gurwith, Marc ^d   Buchbinder, Susan ^a,b  

^a AIDS Office San Francisco   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^d VaxGen Inc   (United States)

^e VaxGen Inc ^*  (United States)

Author keywords

HIV vaccine trial; Negative social impact; Social harm; Trial related discrimination

Indexed keywords

HUMAN IMMUNODEFICIENCY VIRUS VACCINE;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ARTICLE; CLINICAL TRIAL; CONFIDENCE INTERVAL; DISABILITY; DRUG EFFICACY; EMPLOYMENT; FAMILY; FRIEND; GROUPS BY AGE; HARM REDUCTION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HUMAN RELATION; INCIDENCE; INSURANCE; PRIORITY JOURNAL; RISK ASSESSMENT; SEROLOGY; SOCIAL ASPECT; STATISTICAL MODEL; VOLUNTEER;

ADULT; AIDS VACCINES; FAMILY; FEMALE; HIV INFECTIONS; HUMANS; MALE; RISK-TAKING; SOCIAL CHANGE; SOCIAL PROBLEMS; TREATMENT OUTCOME; VOLUNTARY WORKERS;

EID: 37349126956     PISSN: 15254135     EISSN: None     Source Type: Journal    
DOI: 10.1097/QAI.0b013e3181565dcb     Document Type: Article

References (34)

1. International Conference on Harmonization. Guidelines for good clinical practice. Available at: http://www.ich.org/cache/compo/276-254-1.html. Accessed January 8, 2007.
2. Sheon AR, Wagner L, McElrath MJ, et al. Preventing discrimination against volunteers in prophylactic HIV vaccine trials: lessons from a phase II trial. J Acquir Immune Defic Syndr Hum Retrovirol. 1998;19:519-526.
3. Chesney MA, Lurie P, Coates TJ. Strategies for addressing the social and behavioral challenges of prophylactic HIV vaccine trials. J Acquir Immune Defic Syndr Hum Retrovirol. 1995;9:30-35.
4. Frey SE. Unique risks to volunteers in HIV vaccine trials. J Investig Med. 2003;51(Suppl 1):S18-S20.
5. Koblin BA, Heagerty P, Sheon A, et al. Readiness of high-risk populations in the HIV Network for Prevention Trials to participate in HIV vaccine efficacy trials in the United States. AIDS. 1998;12:785-793.
6. Buchbinder SP, Metch B, Holte SE, et al. Determinants of enrollment in a preventive HIV vaccine trial: hypothetical versus actual willingness and barriers to participation. J Acquir Immune Defic Syndr. 2004;36:604-612.
7. Mills E, Cooper C, Guyatt G, et al. Barriers to participating in an HIV vaccine trial: a systematic review. AIDS. 2004;18:2235-2242.
8. Allen M, Israel H, Rybczyk K, et al. Trial-related discrimination in HIV vaccine clinical trials. AIDS Res Hum Retroviruses. 2001;17:667-674.
9. Belshe RB, Stevens C, Gorse GJ, et al. Safety and immunogenicity of a canarypox-vectored human immunodeficiency virus Type 1 vaccine with or without gp120: a phase 2 study in higher- and lower-risk volunteers. J Infect Dis. 2001;183:1343-1352.
10. Harro CD, Judson FN, Gorse GJ, et al. Recruitment and baseline epidemiologic profile of participants in the first phase 3 HIV vaccine efficacy trial. J Acquir Immune Defic Syndr. 2004;37:1385-1392.
11. Flynn NM, Forthal DN, Harro CD, et al. Placebo-controlled phase 3 trial of a recombinant glycoprotein 120 vaccine to prevent HIV-1 infection. J Infect Dis. 2005;191:654-665.
12. AnSWR: Analysis Software for World-based Records [computer program]. Version 6.4. Atlanta, Georgia: Centers for Disease Control and Prevention; 2004. Available at: http://www.cdc.gov/hiv/software/answr.htm. Accessed March 25, 2006.
13. US Census Bureau. United States Census 2000 [Web site]. Available at: http://www.census.gov/main/www/cen2000.html. Accessed March 25, 2006.
14. Statistics Canada. 2001 Census of Population [Web site]. Available at: http://www12.statcan.ca/english/census01/home/Index.cfm. Accessed March 25, 2006.
15. Statistics Netherlands. Centraal Bureau voor de Statistiek. The Dutch Virtual Census of 2001 [Web site]. Available at: http://www.cbs.nl/en-gb/menu/ themas/dossiers/volkstellingen/publicaties/2005-virtual-dutchcensus-art.htm. Accessed March 25, 2006.
16. Smit C, Geskus R, Uitenbroek D, et al. Declining AIDS mortality in Amsterdam: contributions of declining HIV incidence and effective therapy. Epidemiology. 2004;15:536-542.
17. MacDougall RG, Rekart ML, Knowles L, et al. HIV/AIDS Update: Year End 2000. Vancouver, BC, Canada: BC Centre for Disease Control; 2000.
18. Remis RS, Swantee C, Rottensten K, et al. Report on HIV/AIDS in Ontario. Toronto, Ontario, Canada: Ontario HIV Epidemiologic Monitoring Unit, University of Toronto; 2003.
19. Santé et Services sociaux Quebec. Surveillance des cas de syndrome d'immunodeficience acquise (SIDA) cas cumulatifs 1979-2003. Montréal, Québec, Canada: Programme de surveillance du SIDA du Quebec; 2003.
20. Zeger SL, Liang KY. Longitudinal data analysis for discrete and continuous outcomes. Biometrics. 1986;42:121-130.
21. Allen MA, Liang TS, La Salvia T, et al. Assessing the attitudes, knowledge, and awareness of HIV vaccine research among adults in the United States. J Acquir Immune Defic Syndr. 2005;40:617-624.
22. Roberts KJ, Newman PA, Duan N, et al. HIV vaccine knowledge and beliefs among communities at elevated risk: conspiracies, questions and confusion. J Natl Med Assoc. 2005;97:1662-1671.
23. Jenkins RA, Thapinta D, Morgan PA, et al. Behavioral and social issues among volunteers in a preventive HIV vaccine trial in Thailand. J Acquir Immune Defic Syndr. 2005;40:592-599.
24. Allen MA, Metch B, Lau C, et al. Negative social impacts in preventive HIV vaccine clinical trials [abstract OA06-02]. Presented at: AIDS Vaccine 2006; 2006; Amsterdam.
25. Gender, age, and ethnicity in HIV vaccine-related research and clinical trials: report from a WHO-UNAIDS consultation, 26-28 August 2004, Lausanne, Switzerland. AIDS. 2005;19:w7-w28.
26. Swartz L, Kagee A, Kafaar Z, et al. Social and behavioral aspects of child and adolescent participation in HIV vaccine trials. J Int Assoc Physicians AIDS Care. 2005;4:89-92.
27. Fuchs JD, Buchbinder SP. Lessons from the AIDSVAX B/B vaccine efficacy trial. In: Koff WC, Kahn P, Gust ID, eds. AIDS Vaccine Development. Challenges and Opportunities. Norfolk, VA: Caister Academic Press; 2007:105-110.
28. Rothstein MA. Genetics and Life Insurance: Medical Underwriting and Social Policy. 1st ed. Cambridge, MA: The MIT Press; 2004.
29. de Bruyn T. HIV/AIDS and Discrimination: A Discussion Paper. Montreal, Quebec, Canada: Canadian HIV/AIDS Legal Network and Canadian AIDS Society; 1998.
30. Leider PA. Domestic AIDS vaccine trials: addressing the potential for social harm to the subjects of human experiments. Calif Law Rev. 2000;88:1185-1232.
31. Branson BM, Handsfield HH, Lampe MA, et al. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep. 2006;55(RR-14):1-17 [quiz: CE11-CE14].
32. Ackers ML, Parekh B, Evans TG, et al. Human immunodeficiency virus (HIV) seropositivity among uninfected HIV vaccine recipients. J Infect Dis. 2003;187:879-886.
33. Khurana S, Needham J, Mathieson B, et al. Human immunodeficiency virus (HIV) vaccine trials: a novel assay for differential diagnosis of HIV infections in the face of vaccine-generated antibodies. J Virol. 2006;80:2092-2099.
34. Pitisuttithum P, Gilbert P, Gurwith M, et al. Randomized, double-blind, placebo-controlled efficacy trial of a bivalent recombinant glycoprotein 120 HIV-1 vaccine among injection drug users in Bangkok, Thailand. J Infect Dis. 2006;194:1661-1671.