Lessons Learned from HIV Vaccine Clinical Efficacy Trials
Tracey A. Day and James G. Kublin
Affiliation: HIV Vaccine Trials Network, Vaccine and Infectious Disease Institute, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave North, Seattle, WA 98109, USA.
The past few years have witnessed many promising advances in HIV prevention strategies involving preexposure
prophylaxis approaches. Some may now wonder whether an HIV vaccine is still needed, and whether
developing one is even possible. The partial efficacy reported in the RV144 trial and the encouraging results of the
accompanying immune correlates analysis suggest that an effective HIV vaccine is achievable. These successes have
provided a large impetus and guidance for conducting more HIV vaccine trials. A key lesson learned from RV144 is that
assessment of HIV acquisition is now a feasible and valuable primary objective for HIV preventive vaccine trials. In this
article we review how RV144 and other HIV vaccine efficacy trials have instructed the field and highlight some of the
HIV vaccine concepts in clinical development. After a long and significant investment, HIV vaccine clinical research is
paying off in the form of valuable lessons that, if applied effectively, will accelerate the path toward a safe and effective
vaccine. Together with other HIV prevention approaches, preventive and therapeutic HIV vaccines will be invaluable
tools in bringing the epidemic to an end.
Keywords: Efficacy trial, HIV, HIV vaccine trials network, HVTN, HVTN 505, RV144, step study, vaccine.
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