Scientists propose adaptive clinical trials to find HIV vaccine

Scientists working at and funded by the National Institute of Allergy and Infectious Diseases have proposed using adaptive clinical trial designs to accelerate development of an HIV vaccine after a decade of large-scale efficacy trials.  

The NIAID, part of the National Institutes of Health, has proposed this type of trial because it would allow trials to be modified in response to data acquired during the study. This would help scientists to quickly screen out poor vaccine candidates, enable an extended evaluation of promising candidates and provide them with key information on the immunological basis for HIV prevention.

Four large-scale efficacy trials of the HIV vaccines have been conducted in various populations over the last 12 years. The most recent trial, the RV144 trial in Thailand, found that there was a 31 percent reduction in the rate of HIV acquisition among vaccinated heterosexual men and women. While the results gave scientists reason for cautious optimism, the length of traditional HIV vaccine clinical trials would take scientists years to build on these results.

In addition, scientists are still unsure as to what immune system responses an HIV vaccine needs to protect an individual from infection.

In a paper appearing in this week’s Science Translational Medicine, the scientists review the four major HIV vaccine trials undertaken so far and the challenges and scientific questions that remain. The paper describes what is needed to advance HIV vaccines through clinical trials and how adaptive clinical trial designs may lead to acceleration in the identification of an effective HIV vaccine.

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