Using surrogate vaccines to assess feasibility and acceptability of future HIV vaccine trials in men: a randomised trial in inner-city Johannesburg, South AfricaReportar como inadecuado




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BMC Public Health

, Volume 17, Supplement 3, pp 113–122

First Online: 04 July 2017

Abstract

BackgroundDeveloping an effective HIV vaccine is the overriding priority for HIV prevention research. Enrolling and maintaining cohorts of men into HIV vaccine efficacy trials is a necessary prerequisite for the development and licensure of a safe and efficacious vaccine.

MethodsOne hundred-fifty consenting HIV-negative men were enrolled into a pilot 1:1 randomised controlled trial of immediate vaccination with a three-dose hepatitis B vaccine compared to deferred vaccination at 12 months to investigate feasibility and acceptability of a future HIV vaccine trial in this population. Adverse events, changes in risk behaviour, acceptability of trial procedures and motivations for participation in future trials were assessed.

ResultsMen were a median 25 years old inter-quartile range = 23–29, 53% were employed, 90% secondary school educated and 67% uncircumcised. Of the 900 scheduled study visits, 90% were completed in the immediate vaccination arm 405-450 and 88% 396-450 in the delayed arm P = 0.338. Acceptability of trial procedures and services was very high overall. However, only 65% of the deferred group strongly liked being randomised compared to 90% in the immediate group P = 0.001. Informed consent processes were viewed favourably by 92% of the delayed and 82% of the immediate group P = 0.080. Good quality health services, especially if provided by a male nurse, were rated highly. Even though almost all participants had some concern about the safety of a future HIV vaccine 98%, the majority were willing to participate in a future trial. Future trial participation would be motivated mainly by the potential for accessing an effective vaccine 81% and altruism 75%, rather than by reimbursement incentives 2%.

ConclusionsRecruitment and retention of men into vaccine trials is feasible and acceptable in our setting. Findings from this surrogate vaccine trial show a high willingness to participate in future HIV vaccine trials. While access to potentially effective vaccines is important, quality health services are an equally compelling incentive for enrolment.

KeywordsHIV vaccine Trial Men Feasibility Acceptability Sub-Saharan Africa Surrogate vaccine AbbreviationsAEAdverse events

ARTAntiretroviral treatment

DVDeferred vaccination

EDTCPEuropean and Developing Countries Clinical Trials Partnership

HIVHuman immuno-deficiency virus

IVImmediate vaccination

SSASub-Saharan Africa

STISexually transmitted Infection

WTPWillingness to participate

Electronic supplementary materialThe online version of this article doi:10.1186-s12889-017-4355-z contains supplementary material, which is available to authorized users.

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