Answering a Question about Safety and HIV Research for Children

Posted by Robert Yule
Washington, D.C.
May 19, 2011

This week for HIV Vaccine Awareness Day, the Foundation’s Vice President of Research Dr. Laura Guay issued a statement about the importance of including children in future AIDS vaccine clinical trials.

On our Facebook page, one of our readers expressed concern about the potential risks, and asked whether it was safe for infants and children to be a part of these types of trials.

We thought this would be a good opportunity to discuss the issue further on our blog.

Here Dr. Guay explains the safety protocols that are a requirement for any studies which involve children, and why we feel it’s so important that this critical research takes into account the needs of children:

“Thanks so much for your comment. HIV vaccines absolutely need to be tested in adults for safety prior to testing in children. Once safety in adults is verified, testing should begin in children with small studies that include extensive safety monitoring before proceeding to larger studies that test whether the vaccine works to protect children from HIV.

Otherwise, when an effective vaccine is found, children will be left behind without access to this life-saving protection until all these studies are completed much later.

All current vaccine research, as well as research involving children, is conducted according to strict ethical guidelines that are carefully reviewed for regulatory and ethical issues prior to approval. This includes review by relevant authorities in the country where the study is taking place, to ensure that adults and children who participate in research in resource-limited settings are protected.

Unfortunately, these are the populations that are most at risk of acquiring HIV, and therefore they are most in need of the prevention methods that are being tested.”

We appreciate all of your comments and questions on Facebook, Twitter, and our blog – it gives us a chance to engage in a dialogue about our shared goal: the elimination of pediatric AIDS.

To read more about how an HIV vaccine would particularly benefit children, read Dr. Jeffrey Safrit’s blog on this topic from earlier in the week.

Robert Yule is the Foundation’s Senior Media Relations Manager in Washington, D.C.

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Comments

Ellen at 5/22/2011 9:54:38 PM

hanks for this response. I am a researcher, so I am familiar with the process of obtaining ethical approval for research. As I said previously, I have attended a workshop on the research being conducted on new prevention technologies. A...t that workshop, we learned of a study that is currently going on with IV drug users - and as we learned of the details of the study, most of the people in attendance were very concerned about the ethical questions of this study. People are not being provided with what is known as the "gold standard" for prevention in IV drug use - clean needles. It appeared to us (but was not stated explicitly as such by the instructors) that the study is being conducted in Thailand specifically because the researchers could get around providing clean needles because it is illegal to be in possession of drug paraphernalia in that country. Because it was funded under PEPFAR when Bush was president, so federal funds could not be used to provide clean needles. This all seems very convenient - and a bit shocking that it has been allowed to continue after so many people have expressed concerns about the ethics of it all. They will see more HIV infections, which means that their study will need a smaller sample size, be less expensive to conduct, and have more "robust" findings. But should it be going on?? I don't think so. That is only one example of a study that somehow was approved through the ethics process - it is not an infallible process. So while I appreciate Dr. Guay's comments, I still have concerns. I just hope that only the most ethical researchers will include children in their research!

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