Preventing discrimination against volunteers in prophylactic HIV vaccine trials: Lessons from a phase II trial

被引:43
作者
Sheon, AR
Wagner, L
McElrath, MJ
Keefer, MC
Zimmerman, E
Israel, H
Berger, D
Fast, P
机构
[1] NIAID, Div Aids, NIH, Rockville, MD USA
[2] Vanderbilt Univ, Nashville, TN USA
[3] Univ Washington, Fred Hutchinson Canc Res Ctr, Sch Med, Seattle, WA 98195 USA
[4] Univ Rochester, Sch Med & Dent, Rochester, NY USA
[5] Johns Hopkins Univ, Sch Hyg & Publ Hlth, Baltimore, MD USA
[6] St Louis Univ, Sch Med, St Louis, MO USA
[7] Univ Washington, Sch Med, Seattle, WA USA
来源
JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES AND HUMAN RETROVIROLOGY | 1998年 / 19卷 / 05期
关键词
HIV-I vaccines; discrimination; homosexuality; male; intravenous drug users; social harm; HIV testing; HIV antibodies; controlled clinical trials; HIV infections; patient participation;
D O I
10.1097/00042560-199812150-00012
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Context: Preventive HIV vaccines can temporarily cause uninfected individuals to have positive results on HIV testing. As preparations are underway to mount larger efficacy trials, the social risks of trial participation should be studied. Objective: To describe frequency of HIV testing and discrimination among participants in a preventive phase II HIV vaccine trial. Participants: 266 vaccine trial volunteers were eligible; 247 participated in a confidential survey. Results: 63 volunteers (26% of respondents) reported 185 HIV tests during the prior 12 to 24 months; most tests were for other research studies, health care, insurance, incarceration, or employment. Only 5 volunteers reported having positive HIV test results. Volunteers reported 99 adverse social incidents or problems, 53 of which were related to the trial. The most common type of event occurred when volunteers disclosed their trial participation and were mistakenly presumed to be infected with HIV. Few reported difficulty obtaining insurance, job loss, and inadvertent disclosure of their participation in the trial. Conclusion: In this vaccine trial, few serious social harms were reported. Those who conduct HIV tests for insurance, employment, health care, or other reasons should be made aware that HIV vaccines can cause false-positive HIV test results. Those planning future trials must continue to provide needed support to volunteers. Social harms should be monitored with the same vigilance accorded to physical harms.
引用
收藏
页码:519 / 526
页数:8
相关论文
共 39 条
[1]  
*AIDS ACT FDN, 1994, HIV PREV VACC SOC ET
[2]  
[Anonymous], SEARCH AIDS VACCINE
[3]  
[Anonymous], 1978, BELM REP ETH PRINC G
[4]   INTERPRETING HIV SERODIAGNOSTIC TEST-RESULTS IN THE 1990S - SOCIAL RISKS OF HIV VACCINE STUDIES IN UNINFECTED VOLUNTEERS [J].
BELSHE, RB ;
CLEMENTS, ML ;
KEEFER, MC ;
GRAHAM, BS ;
COREY, L ;
SPOSTO, R ;
WESCOTT, S ;
LAWRENCE, D ;
GORSE, GJ ;
KENNEDY, D ;
FREY, S ;
LAMBERT, J ;
SCHWARTZ, D ;
DOLIN, R ;
ROBERTS, N ;
MCELRATH, J ;
COOMBS, J ;
WRIGHT, P ;
KARZON, D ;
FAST, P ;
WALKER, MC ;
MESTECKY, J ;
JACKSON, S ;
STABLEIN, D ;
WOLFF, M .
ANNALS OF INTERNAL MEDICINE, 1994, 121 (08) :584-+
[5]  
Burris S, 1997, AIDS PUBLIC POLICY J, V12, P66
[6]   WILLINGNESS TO PARTICIPATE IN AIDS VACCINE TRIALS AMONG HIGH-RISK POPULATIONS IN NORTHERN THAILAND [J].
CELENTANO, DD ;
BEYRER, C ;
NATPRATAN, C ;
EIUMTRAKUL, S ;
SUSSMAN, L ;
RENZULLO, PO ;
KHAMBOONRUANG, C ;
NELSON, KE .
AIDS, 1995, 9 (09) :1079-1083
[7]   Risk behavior for HIV infection in participants in preventive HIV vaccine trials: A cautionary note [J].
Chesney, MA ;
Chambers, DB ;
Kahn, JO .
JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES AND HUMAN RETROVIROLOGY, 1997, 16 (04) :266-271
[8]  
CHESNEY MA, 1995, J ACQ IMMUN DEF SYND, V9, P30
[9]  
COLLINS C, 1996, 2 U CAL CTR AIDS PRE
[10]  
DOUGLAS JM, 1994, AIDS RES HUM RETROV, V10, pS257