Research Roundup: Gates Foundation open access policy, Ebola vaccine market, World AIDS Day, and more

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. According to a recent study out of Oxford University, rapid evolution of the HIV virus is slowing the virus’s ability to cause AIDS. In this study of 2,000 women in South Africa and Botswana, researchers found that the HIV virus had evolved to adapt to a specific gene known as HLA-B*57, which provides some protective effect against HIV, slowing the progress to AIDS. As the virus has adapted to reduce this protective effect in individuals, the virus has also reduced its ability to replicate, making it less virulent over all. Last Thursday, the UN Secretary-General launched his synthesis report for the sustainable development goals. In this report, Secretary General Ban Ki-moon reaffirmed his support for the 17 goals and 160 targets proposed by the United Nations Open Working Group, despite concerns from some member states that the current list is too long. Of the 17 proposed goals, two contain targets related to the research and development of new technologies. Researchers are developing a powdered form of the measles vaccine which could make it easier and safer to deliver the vaccine to people in developing nations. The current FDA-approved measles vaccine is a live virus that has been freeze-dried into a powder, which requires reconstitution with water before being administered via syringe. The new vaccine under development is a powder that can be inhaled. This new formulation would eliminate the need for sterile water and needles, as well as cold-chain storage. A modified regimen of the HIV vaccine candidate RV144 was shown to be safe and capable of inducing a robust immune response in safety trials in South Africa. RV144—which was developed by the US and Thai military—showed early promise in clinical trials, but it was found to lose efficacy over time. This new regime is the same earlier RV144 vaccine regime with an added booster shot one year later. Further clinical trials of this new regime are set to begin in South Africa in early 2015.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Last week we learned just how much pharmaceutical companies think a fast track review by the Food and Drug Administration (FDA) could be worth. Gilead Sciences paid US$125 million via auction to purchase a priority review voucher from Knight Therapeutics. This voucher will allow Gilead to shave four months off of the FDA review time for a drug of its choice. The priority review voucher system was created in 2007 to incentivize development of drugs for neglected diseases. Bloomberg reports on a recent study out of the Tufts Center for the Study of Drug Development which found it costs pharmaceutical companies on average $2.56 billion to bring a new drug to market. This is more than twice the cost it took 11 years ago. According to the study’s author, this higher cost results from larger and more complex clinical trials, as well as the number of drugs that fail in development. The Bill & Melinda Gates Foundation last week pledged $5.7 million to test potential treatments for Ebola. The research being funded will examine the effectiveness of using blood plasma taken from Ebola survivors to treat those infected, as well the effectiveness of an experimental antiviral drug called brincidofovir. While it has been common practice for decades for doctors to use blood donations from Ebola survivors as a form of treatment, there has not yet been rigorous studies conducted to examine the effectiveness of this practice until now. The US Department of Health and Human Services last Wednesday unveiled new proposed reporting requirements or clinical researchers registering and submitting results to ClinicalTrials.gov. The most significant proposed change is that companies will be required to submit summary results from trials even if the product has not been approved or licensed for use in the United States.