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January 26, 1994, Vol 271, No. 4 >
ARTICLE | January 26, 1994

Ethical, Behavioral, and Social Aspects of HIV Vaccine Trials in Developing Countries FREE

Peter Lurie, MD, MPH; Makonnen Bishaw, PhD; Margaret A. Chesney, PhD; Molly Cooke, MD; Maria Eugenia Lemos Fernandes, MD; Norman Hearst, MD, MPH; Edward Katongole-Mbidde, MD; Suporn Koetsawang, MD; Christina P. Lindan, MD; Jeffrey Mandel, PhD, MPH; Marvellous Mhloyi, PhD; Thomas J. Coates, PhD
[+] Author Affiliations

Reprint requests to the Center for AIDS Prevention Studies, University of California, 74 New Montgomery St, Sixth Floor, San Francisco, CA 94105 (Dr Lurie).


JAMA. 1994;271(4):295-301. doi:10.1001/jama.1994.03510280057033
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Article
References

Issue.  —Several investigators are preparing to conduct efficacy trials of human immunodeficiency virus (HIV) vaccines in the developing world. Failure to adequately address the unique ethical, behavioral, and social issues that surround vaccine testing in that setting will jeopardize the success of these trials and future acquired immunodeficiency syndrome (AIDS) research in the host nation.

Description of the Project.  —Twelve investigators from Africa, Asia, North America, and South America reviewed previous experience with HIV trials in developing countries and explored potential solutions to these issues.

Conclusions.  —Host country scientists, government officials, and media must be actively involved in all aspects of the trials. Minimum prerequisites for conducting the trial include the following: (1) researching vaccines active against developing world HIV isolates; (2) establishing and maintaining an adequate technological infrastructure; (3) assessing the feasibility of recruitment in countries where the existence of HIV may be denied; (4) designing methods to obtain informed consent from each individual subject, rather than exclusively from family members or community elders; (5) creating locally appropriate instruments to measure risk behavior; (6) identifying a behavioral intervention for placebo and treatment groups; (7) making available laboratory methods to distinguish between natural HIV infection and vaccine-induced seropositivity; and (8) guaranteeing that an effective vaccine is available free of charge to the placebo group and at affordable prices to other host country residents.(JAMA. 1994;271:295-301)

REFERENCES

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Koff WC, Fast PE, Schultz AM, et al. Prevention of AIDS and STDs: vaccine challenges for the 1990s and beyond. In: Program and abstracts of the 8th International Conference on AIDS; July 19-24, 1992; Amsterdam, the Netherlands. Abstract PoA 2245.
2 +
Global Programme on AIDS. Statement From the Consultation on Criteria for International Testing of Candidate HIV Vaccines . Geneva, Switzerland: World Health Organization; February 27-March 2, 1989;.
3 +
Esparza J, Osmanov S, Heymann D. Preparation for efficacy trials of HIV candidate vaccines: the role of the World Health Organization. In: Program and abstracts of the 9th International Conference on AIDS; June 10, 1993; Berlin, Germany. Oral presentation WS-C20-1.
4 +
Walters L.  Ethical issues in the prevention and treatment of HIV infection and AIDS. Science . 1988;; 239:597-603.
5 +
Winkelstein W, Wiley JA, Garrett K, et al. The San Francisco Young Men's Health Study: Preliminary Findings. Presented at the Future of HIV Vaccines; August 28,1992; San Francisco, Calif.
6 +
Marmor M, Wolfe H, Des Jarlais D, et al. Feasibility of future HIV vaccine trials in New York City injecting drug users (IDUs) and their sexual partners. In: Program and abstracts of the 9th International Conference on AIDS; June 10, 1993; Berlin, Germany. Oral presentation WS-C20-4.
7 +
Christakis NA.  The ethical design of an AIDS vaccine trial in Africa. Hastings Cent Rep . 1988;; (June/July) :31-37.
8 +
Sabatier R. Blaming Others: Prejudice, Race and Worldwide AIDS . London, England: Panos Publications; 1988;.
9 +
Marwick C.  NIH collaboration with French AIDS vaccine researcher put on hold pending investigation. JAMA . 1991;;265:2648-2650.
10 +
Konotey-Ahulu FID.  AIDS in Africa: misinformation and disinformation. Lancet . 1987;;2:206-207.
11 +
National Institute of Allergy and Infectious Diseases.  Preparation for AIDS/HIV vaccine evaluations. NIH Guide Grants Contracts . 1992;;21( (8) ):3-5.
12 +
Vermund SH, Hoff R, Lawrence DN, et al. HIV vaccine efficacy trial preparations. In: Program and abstracts of the 8th International Conference on AIDS; July 19-24, 1992; Amsterdam, the Netherlands. Abstract PoC 4505.
13 +
Enel P, Charrel J, Larher M-P, et al.  HIV vaccination: the ethical issues. AIDS Public Policy J . 1992;;7:50-55.
14 +
Ndinya-Achola JO.  A review of ethical issues in AIDS research. East Afr Med J . 1991;;68:735-740.
15 +
Medical Research Council. The Ethical Conduct of AIDS Vaccine Trials: Report of the Working Party on Ethical Aspects of AIDS Vaccine Trials . London, England: Medical Research Council; 1991;.
16 +
Lamptey P, Clottey C, Lurie P. HIV vaccine policy issues: the developing world perspective. In: Program and abstracts of the 8th International Conference on AIDS; July 22, 1992; Amsterdam, the Netherlands. Oral minicourse presentation 95.
17 +
Cohen J.  Did political clout win vaccine trial for MicroGeneSys? Science . 1992;;258:211.
18 +
Cohen J.  Lobbying for an AIDS trial. Science . 1992;;258:536-539.
19 +
Cohen J.  Agencies spar over vaccine trial. Science . 1993;;259:752-753.
20 +
Melton GB, Levine RJ, Koocher GP, Rosenthal R, Thompson WC.  Community consultation in socially sensitive research: lessons learned from clinical trials of treatments for AIDS. Psychologist . 1988;;43:573-581.
21 +
Matthews TJ, Bolognesi DP.  AIDS vaccines. Sci Am . 1988;;4:120-127.
22 +
Mariner WK.  Why clinical trials of AIDS vaccines are premature. Am J Public Health . 1989;; 79:86-91.
23 +
Katzenstein DA, Sawyer LA, Quinnan GV.  Issues in the evaluation of AIDS vaccines. AIDS . 1988;;2:151-155.
24 +
Rothman DJ.  Ethical and social issues in the development of new drugs and vaccines. Bull N Y Acad Med . 1987;;63:557-568.
25 +
Barrick B, Berkebile C, Cuda S, et al. Motivations of persons volunteering for an AIDS vaccine trial. In: Program and abstracts of the 4th International Conference on AIDS; June 12-16, 1988; Stockholm, Sweden. Abstract 6575.
26 +
Souteyrand Y, Pialoux G, Linard F, et al. Selection of volunteers for trials of HIV vaccines: problems in methods. In: Program and abstracts of the 8th International Conference on AIDS; July 19-24,1992; Amsterdam, the Netherlands. Abstract PoB 3041.
27 +
Grant RM, Baingana G, LeBlond RF, Nsubuga PS, Katongole-Mbidde E. Attitudes toward possible HIV vaccination trials in a sexually active Ugandan population. In: Program and abstracts of the 8th International Conference on AIDS; July 19-24,1992; Amsterdam, the Netherlands. Abstract PoD 5840.
28 +
LeBlond RF, Baingana G, Grant RM, Kwesi M, Walker CK, Katongole-Mbidde E. Problems with informed consent in clinical studies of Ugandan adults. In: Program and abstracts of the 8th International Conference on AIDS;July 19-24, 1992; Amsterdam, the Netherlands. Abstract PoC 4508.
29 +
Serwadda D, Katongole-Mbidde E.  AIDS in Africa: problems for research and researchers. Lancet . 1990;;335:842-843.
30 +
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research . Washington, DC: US Dept of Health, Education, and Welfare; 1978;. US Dept of Health, Education, and Welfare publication OS 78-0012.
31 +
Tacket CO, Edelman R.  Ethical issues involving volunteers in AIDS vaccine trials. J Infect Dis . 1990;;161:356.
32 +
Koff WC, Hoth DF.  Development and testing of AIDS vaccines. Science . 1988;;241:426-432.
33 +
Ankrah EM.  AIDS: methodological problems in studying its prevention and spread. Soc Sci Med . 1989;;29:265-276.
34 +
Ajayi 00.  Taboos and clinical research in West Africa. J Med Ethics . 1980;;6:61-63.
35 +
Allen S, Serufilira A, Bogaerts J, et al.  Confidential HIV testing and condom promotion in Africa: impact on HIV and gonorrhea rates. JAMA . 1992;;268:3338-3343.
36 +
AIDS Directed Programme. Practical and Technical Issues in the Conduct of HIV Vaccine Trials . London, England: Medical Research Council; 1990;.
37 +
Schild GC, Minor PD.  Human immunodeficiency virus and AIDS: challenges in progress. Lancet . 1990;;335:1081-1084.
38 +
Merz B.  HIV vaccine approved for clinical trials. JAMA . 1987;;258:1433-1434.
39 +
Barry M.  Ethical imperialism. N Engl J Med . 1990;;322:201.
40 +
Ijsselmuiden CB, Faden RR.  Research and informed consent in Africa: another look. N Engl J Med . 1992;;326:830-834.
41 +
Schoepf BG.  Ethical, methodological and political issues of AIDS research in Central Africa. Soc Sci Med . 1991;;33:749-763.
42 +
Barry M.  Informed consent in Africa. N Engl J Med . 1992;;327:1103.
43 +
Ulin PR.  African women and AIDS: negotiating behavioral change. Soc Sci Med . 1992;;34:63-73.
44 +
Cohen J.  Army investigates researcher's report of clinical trial data. Science . 1992;;258:883-884.
45 +
Cheyne J.  Vaccine delivery management. Rev Infect Dis . 1989;;11( (suppl 3) ):5617-5621.
46 +
Blower SM, McLean AR. Imperfect HIV vaccines, the consequences for epidemic control and clinical trials. In: Program and abstracts of the 9th International Conference on AIDS; June 6-11,1993; Berlin, Germany. Abstract P0-C34-3346.
47 +
Macklin R, Friedland G.  AIDS research: the ethics of clinical trials. Law Med Health Care . 1986;; 14:273-280.
48 +
Cohen J.  AIDS vaccine trials: bumpy road ahead. Science . 1991;;251:1312-1313.
49 +
Osborn JE. The prospects for practical use of an HIV vaccine. In: Program and abstracts of the 8th International Conference on AIDS; July 22, 1992; Amsterdam, the Netherlands. Oral presentation 63.

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Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature

Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal

1 +
Koff WC, Fast PE, Schultz AM, et al. Prevention of AIDS and STDs: vaccine challenges for the 1990s and beyond. In: Program and abstracts of the 8th International Conference on AIDS; July 19-24, 1992; Amsterdam, the Netherlands. Abstract PoA 2245.
2 +
Global Programme on AIDS. Statement From the Consultation on Criteria for International Testing of Candidate HIV Vaccines . Geneva, Switzerland: World Health Organization; February 27-March 2, 1989;.
3 +
Esparza J, Osmanov S, Heymann D. Preparation for efficacy trials of HIV candidate vaccines: the role of the World Health Organization. In: Program and abstracts of the 9th International Conference on AIDS; June 10, 1993; Berlin, Germany. Oral presentation WS-C20-1.
4 +
Walters L.  Ethical issues in the prevention and treatment of HIV infection and AIDS. Science . 1988;; 239:597-603.
5 +
Winkelstein W, Wiley JA, Garrett K, et al. The San Francisco Young Men's Health Study: Preliminary Findings. Presented at the Future of HIV Vaccines; August 28,1992; San Francisco, Calif.
6 +
Marmor M, Wolfe H, Des Jarlais D, et al. Feasibility of future HIV vaccine trials in New York City injecting drug users (IDUs) and their sexual partners. In: Program and abstracts of the 9th International Conference on AIDS; June 10, 1993; Berlin, Germany. Oral presentation WS-C20-4.
7 +
Christakis NA.  The ethical design of an AIDS vaccine trial in Africa. Hastings Cent Rep . 1988;; (June/July) :31-37.
8 +
Sabatier R. Blaming Others: Prejudice, Race and Worldwide AIDS . London, England: Panos Publications; 1988;.
9 +
Marwick C.  NIH collaboration with French AIDS vaccine researcher put on hold pending investigation. JAMA . 1991;;265:2648-2650.
10 +
Konotey-Ahulu FID.  AIDS in Africa: misinformation and disinformation. Lancet . 1987;;2:206-207.
11 +
National Institute of Allergy and Infectious Diseases.  Preparation for AIDS/HIV vaccine evaluations. NIH Guide Grants Contracts . 1992;;21( (8) ):3-5.
12 +
Vermund SH, Hoff R, Lawrence DN, et al. HIV vaccine efficacy trial preparations. In: Program and abstracts of the 8th International Conference on AIDS; July 19-24, 1992; Amsterdam, the Netherlands. Abstract PoC 4505.
13 +
Enel P, Charrel J, Larher M-P, et al.  HIV vaccination: the ethical issues. AIDS Public Policy J . 1992;;7:50-55.
14 +
Ndinya-Achola JO.  A review of ethical issues in AIDS research. East Afr Med J . 1991;;68:735-740.
15 +
Medical Research Council. The Ethical Conduct of AIDS Vaccine Trials: Report of the Working Party on Ethical Aspects of AIDS Vaccine Trials . London, England: Medical Research Council; 1991;.
16 +
Lamptey P, Clottey C, Lurie P. HIV vaccine policy issues: the developing world perspective. In: Program and abstracts of the 8th International Conference on AIDS; July 22, 1992; Amsterdam, the Netherlands. Oral minicourse presentation 95.
17 +
Cohen J.  Did political clout win vaccine trial for MicroGeneSys? Science . 1992;;258:211.
18 +
Cohen J.  Lobbying for an AIDS trial. Science . 1992;;258:536-539.
19 +
Cohen J.  Agencies spar over vaccine trial. Science . 1993;;259:752-753.
20 +
Melton GB, Levine RJ, Koocher GP, Rosenthal R, Thompson WC.  Community consultation in socially sensitive research: lessons learned from clinical trials of treatments for AIDS. Psychologist . 1988;;43:573-581.
21 +
Matthews TJ, Bolognesi DP.  AIDS vaccines. Sci Am . 1988;;4:120-127.
22 +
Mariner WK.  Why clinical trials of AIDS vaccines are premature. Am J Public Health . 1989;; 79:86-91.
23 +
Katzenstein DA, Sawyer LA, Quinnan GV.  Issues in the evaluation of AIDS vaccines. AIDS . 1988;;2:151-155.
24 +
Rothman DJ.  Ethical and social issues in the development of new drugs and vaccines. Bull N Y Acad Med . 1987;;63:557-568.
25 +
Barrick B, Berkebile C, Cuda S, et al. Motivations of persons volunteering for an AIDS vaccine trial. In: Program and abstracts of the 4th International Conference on AIDS; June 12-16, 1988; Stockholm, Sweden. Abstract 6575.
26 +
Souteyrand Y, Pialoux G, Linard F, et al. Selection of volunteers for trials of HIV vaccines: problems in methods. In: Program and abstracts of the 8th International Conference on AIDS; July 19-24,1992; Amsterdam, the Netherlands. Abstract PoB 3041.
27 +
Grant RM, Baingana G, LeBlond RF, Nsubuga PS, Katongole-Mbidde E. Attitudes toward possible HIV vaccination trials in a sexually active Ugandan population. In: Program and abstracts of the 8th International Conference on AIDS; July 19-24,1992; Amsterdam, the Netherlands. Abstract PoD 5840.
28 +
LeBlond RF, Baingana G, Grant RM, Kwesi M, Walker CK, Katongole-Mbidde E. Problems with informed consent in clinical studies of Ugandan adults. In: Program and abstracts of the 8th International Conference on AIDS;July 19-24, 1992; Amsterdam, the Netherlands. Abstract PoC 4508.
29 +
Serwadda D, Katongole-Mbidde E.  AIDS in Africa: problems for research and researchers. Lancet . 1990;;335:842-843.
30 +
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research . Washington, DC: US Dept of Health, Education, and Welfare; 1978;. US Dept of Health, Education, and Welfare publication OS 78-0012.
31 +
Tacket CO, Edelman R.  Ethical issues involving volunteers in AIDS vaccine trials. J Infect Dis . 1990;;161:356.
32 +
Koff WC, Hoth DF.  Development and testing of AIDS vaccines. Science . 1988;;241:426-432.
33 +
Ankrah EM.  AIDS: methodological problems in studying its prevention and spread. Soc Sci Med . 1989;;29:265-276.
34 +
Ajayi 00.  Taboos and clinical research in West Africa. J Med Ethics . 1980;;6:61-63.
35 +
Allen S, Serufilira A, Bogaerts J, et al.  Confidential HIV testing and condom promotion in Africa: impact on HIV and gonorrhea rates. JAMA . 1992;;268:3338-3343.
36 +
AIDS Directed Programme. Practical and Technical Issues in the Conduct of HIV Vaccine Trials . London, England: Medical Research Council; 1990;.
37 +
Schild GC, Minor PD.  Human immunodeficiency virus and AIDS: challenges in progress. Lancet . 1990;;335:1081-1084.
38 +
Merz B.  HIV vaccine approved for clinical trials. JAMA . 1987;;258:1433-1434.
39 +
Barry M.  Ethical imperialism. N Engl J Med . 1990;;322:201.
40 +
Ijsselmuiden CB, Faden RR.  Research and informed consent in Africa: another look. N Engl J Med . 1992;;326:830-834.
41 +
Schoepf BG.  Ethical, methodological and political issues of AIDS research in Central Africa. Soc Sci Med . 1991;;33:749-763.
42 +
Barry M.  Informed consent in Africa. N Engl J Med . 1992;;327:1103.
43 +
Ulin PR.  African women and AIDS: negotiating behavioral change. Soc Sci Med . 1992;;34:63-73.
44 +
Cohen J.  Army investigates researcher's report of clinical trial data. Science . 1992;;258:883-884.
45 +
Cheyne J.  Vaccine delivery management. Rev Infect Dis . 1989;;11( (suppl 3) ):5617-5621.
46 +
Blower SM, McLean AR. Imperfect HIV vaccines, the consequences for epidemic control and clinical trials. In: Program and abstracts of the 9th International Conference on AIDS; June 6-11,1993; Berlin, Germany. Abstract P0-C34-3346.
47 +
Macklin R, Friedland G.  AIDS research: the ethics of clinical trials. Law Med Health Care . 1986;; 14:273-280.
48 +
Cohen J.  AIDS vaccine trials: bumpy road ahead. Science . 1991;;251:1312-1313.
49 +
Osborn JE. The prospects for practical use of an HIV vaccine. In: Program and abstracts of the 8th International Conference on AIDS; July 22, 1992; Amsterdam, the Netherlands. Oral presentation 63.

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