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

BMC Public Health

Research

Helen Rees¹  Lucy Chimoyi¹  Jonathan Stadler¹  Sinead Delany-Moretlwe¹  Matthew F. Chersich¹  Mphatso Kamndaya¹  Nina von Knorring²  Emilie Venables³  Catherine MacPhail⁴ 

[1] Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa;Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa;Clinical Microbiology and Infectious Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa;Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa;Division of Social and Behavioural Sciences, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa;Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa;School of Health and Society, University of Wollongong, Wollongong, NSW, Australia;

关键词: HIV vaccine;    Trial;    Men;    Feasibility;    Acceptability;    Sub-Saharan Africa;    Surrogate vaccine;   

DOI  :  10.1186/s12889-017-4355-z

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY   
© The Author(s). 2017