From the Laboratory to Clinical Trials and Back Again: Lessons Learned from HIV Prevention Trials
Article first published online: 13 DEC 2012
© 2012 John Wiley & Sons A/S
American Journal of Reproductive Immunology
Special Issue: Sexual Violence and HIV Transmission
Volume 69, Issue Supplement s1, pages 106–115, February 2013
How to Cite
From the laboratory to clinical trials and back again: lessons learned from HIV prevention trialsAm J Reprod Immunol 2012, .
- Issue published online: 6 FEB 2013
- Article first published online: 13 DEC 2012
- Manuscript Accepted: 22 OCT 2012
- Manuscript Received: 31 JUL 2012
- HIV ;
Inadequate, irrelevant, or inappropriate timing of biological specimen collection during clinical trials is a cause for delay in understanding and explaining correlates of protection and/or effectiveness, particularly at the portal of entry in the context of sexual HIV transmission and its prevention.
We present examples of HIV prevention trials to illustrate the impact of preplanned versus unplanned laboratory science program on the interpretation of trial results and advancement of the field.
Of the five completed pre-exposure prophylaxis trials, only two announced main outcome results simultaneously with data on correlates of drug-related effectiveness. In four of the vaccine trials completed, the only one that showed a protective effect presented data on protection correlates significantly later.
Clinical trials must preplan collaborative immunophysiological research and prioritize biological specimen collection and storage for enhancement of research on correlates of protection. Similarly appropriate specimens should be prioritized for pathogenesis research.