Recent developments in clinical trial designs for HIV vaccine research

Abstract

HIV vaccine strategies are expected to be a crucial component for controlling the HIV epidemic. Despite the large spectrum of potential candidate vaccines for both prophylactic and therapeutic use, the overall development process of an efficacious HIV vaccine strategy is lengthy. The design of clinical trials and the progression of a candidate strategy through the different clinical development stages remain methodologically challenging, mainly due to the lack of validated correlates of protection. In this review, we describe recent advances in clinical trial designs to increase the efficiency of the clinical development of candidate HIV vaccine strategies. The methodological aspects of the designs for early- (phase I and II) and later –stage (phase IIB and III) development are discussed, taking into account the specificities of both prophylactic and therapeutic HIV vaccine development.

Keywords:

• AIDS vaccines
• clinical trials
• epidemiologic research design
• HIV
• prevention
• treatment outcome
• therapeutic use

Abbreviations:

• Ad5
• Adenovirus 5
• DNA, deoxyribonucleic acid
• HIV
• human immunodeficiency virus
• IDU
• intravenous drug users
• IFN-γ
• interferon-gamma
• MSM
• men having sex with men
• PrEP
• pre-exposure prophylaxis
• RNA
• ribonucleic acid

Disclosure of Potential Conflicts of Interest

No potential conflicts of interest were disclosed.