Preventing Discrimination Against Volunteers in Prophylactic HIV Vaccine Trials: Lessons From a Phase II Trial

Sheon, Amy R.; Wagner, L; Mj, McElrath; Mc, Keefer; Zimmerman, Emily; Israel, Heidi; Berger, David; Fast, Patricia E.

doi:10.1097/00042560-199812150-00012

Cited by 44 publications

(41 citation statements)

References 16 publications

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“…16,27,32,33 In several studies, discrimination ranged from < 5% to 30%. [34][35][36][37][38][39][40] Only about 4% of participants reported PIEs in this study, a finding that was similar to another trial in Thailand. 40 This could be due to differences in the background and culture of the study community as well as different procedures in assessing PIEs among participants.…”

Section: Discussionsupporting

confidence: 77%

Issues in Women's Participation in a Phase III Community HIV Vaccine Trial in Thailand

Kaewkungwal

Pitisuttithum

Rerks-Ngarm

et al. 2013

AIDS Research and Human Retroviruses

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To assess qualities and outcomes of women participating in a large, community-based HIV vaccine trial, the present study was conducted among female participants of the RV 144 prime-boost trial in Thailand from 2003 to 2009. Qualities of participation refer to complete vaccination, retention, and status change. Outcomes of participation refer to incident rate, adverse event, and participation impact event. A total of 6,334 (38.6%) women participated in the trial, of whom about 50% were classified as low risk and 11% as high risk. About 85% of participants completed four vaccinations and 76% were included in the per-protocol analysis of the on-time vaccination schedule. More women (88%) completed 42 months follow-up compared with men (85%). Women aged 21 and above had more adverse events compared to younger age groups. More women (5%) compared with men (3%) reported participation impact events (PIEs). High-risk women had more PIEs and a higher infection rate compared to the low-risk group. Complete vaccination and retention on last follow-up were more common in married women aged above 21, and being a housewife. Female volunteers showed the same qualities and outcomes of participation as males in the HIV vaccine trial. There was no statistically significant difference in vaccine efficacy between men and women, especially among the high-risk and married women. The study highlighted the important behavioral, social, and cultural issues that could be considered for future HIV vaccine trial designs.

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Section: Discussionsupporting

confidence: 77%

Issues in Women's Participation in a Phase III Community HIV Vaccine Trial in Thailand

Kaewkungwal

Pitisuttithum

Rerks-Ngarm

et al. 2013

AIDS Research and Human Retroviruses

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“…17,18 In addition to mistrust of research, social stigma related to HIV is another barrier to participation in trials that can be especially acute in communities of color. [19][20][21][22] The lesson for HIV vaccine development is that early and meaningful involvement of communities of color in HIV vaccine trials is important to building trust with communities, and to ensuring that there is a track record of safety and efficacy of candidate vaccines trials that have included racial/ethnic minorities.…”

Section: Enrollment Trends Of Racial/ethnic Minoritiesmentioning

confidence: 99%

Enrollment of Racial/Ethnic Minorities in NIAID-Funded Networks of HIV Vaccine Trials in the United States, 1988 to 2002

et al. 2005

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Objective. The purpose of this study was to analyze enrollment of racial/ethnic minorities in Phase I and Phase II HIV vaccine trials in the U.S. conducted by National Institute of Allergy and Infectious Diseases (NIAID)-funded networks from 1988 to 2002. Methods. A centralized database was searched for all NIAID-funded networks of HIV vaccine trial enrollment data in the U.S. from 1988 through 2002. The authors reviewed data from Phase I or Phase II preventive HIV vaccine trials that included HIV-1 uninfected participants at low to moderate or high risk for HIV infection based on self-reported risk behaviors. Of 66 identified trials, 55 (52 Phase I, 3 Phase II) met selection criteria and were used for analyses. Investigators extracted data on participant demographics using statistical software. Results. A total of 3,731 volunteers enrolled in U.S. NIAID-funded network HIV vaccine trials from 1988 to 2002. Racial/ethnic minority participants represented 17% of the overall enrollment. By pooling data across all NIAID-funded networks from 1988 to 2002, the proportion of racial/ethnic minority participants was significantly greater (Fisher's exact test p-value <0.001) in Phase II trials (278/1,061 or 26%) than in Phase I trials (347/2,670 or 13%). By generalized estimating equations, the proportion of minorities in Phase I trials increased over time ( p=0.017), indicating a significant increase in racial/ethnic minority participants from 1988 to 2002. Conclusions. There has been a gradual increase in racial/ethnic minority participation in NIAID-funded network HIV vaccine trials in the U.S. since 1988. In the light of recent efficacy trial results, it is essential to continue to increase the enrollment of diverse populations in HIV vaccine research.

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“…Secondly, licensure requires testing in fully representative populations. And thirdly, participants in AIDS vaccine research benefit from risk-reduction education, counselling and care; excluding women who are eligible to participate would not only be discriminatory, but would also be unethical based on the principle of equity (3,4,6).…”

Section: Introductionmentioning

confidence: 99%

Pregnancy rates among female participants in phase 1 and phase 2A AIDS vaccine clinical trials in Kenya

Jaoko¹,

Ogutu²,

Wakasiaka³

et al. 2010

E Af Med Jrnl

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Background: Female participants in AIDS candidate vaccine clinical trials must agree to use effective contraception to be enrolled into the studies, and for a specified period after vaccination, since the candidate vaccines' effects on the embryo or foetus are unknown. Objectives: To review data on female participants' pregnancy rates from phase I and IIA AIDS vaccine clinical trials conducted at the Kenya AIDS Vaccine Initiative (KAVI) and to discuss the challenges of contraception among female participants. Design: Descriptive observational retrospective study. Setting: KAVI clinical trial site, Kenyatta National Hospital and University of Nairobi, Kenya. Subjects: Thirty nine female participants were enrolled into these trials. They received family planning counselling and were offered a choice of different contraceptive methods, as per the protocols. All contraception methods chosen by the participants were offered at the study site at no cost to the participant. Results: Four women conceived during the study period when pregnancies were to be avoided. All four had opted for sexual abstinence as a contraceptive method, but reported having been coerced by their partners to have unprotected sexual intercourse. Conclusion: Abstinence is clearly not a reliable contraceptive option for women in developing-country settings. Effective female-controlled contraceptives, administered at the clinical trial site, may empower female participants to better control their fertility, leading to more complete clinical trial data.

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Preventing Discrimination Against Volunteers in Prophylactic HIV Vaccine Trials: Lessons From a Phase II Trial

Cited by 44 publications

References 16 publications

Issues in Women's Participation in a Phase III Community HIV Vaccine Trial in Thailand

Issues in Women's Participation in a Phase III Community HIV Vaccine Trial in Thailand

Enrollment of Racial/Ethnic Minorities in NIAID-Funded Networks of HIV Vaccine Trials in the United States, 1988 to 2002

Pregnancy rates among female participants in phase 1 and phase 2A AIDS vaccine clinical trials in Kenya

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