May 15, 2006

The FDA has issued a guidance for organizers of studies to develop a preventive pediatric HIV vaccine that could be licensed for use on children. The document includes recommendations for investigators and institutional review boards (IRBs) that are involved with these pediatric studies.

The guidance directs sponsors and investigators to examine the other regulations, statutes and guidances that outline the special considerations for conducting clinical studies on children.

More specifically, the document addresses issues about developing a preventive HIV vaccine for use in healthy U.S. pediatric populations. "Because the prevalence of HIV infection in these populations is low, the risks presented by studies on these pediatric subjects would need to be commensurately low," the guidance states. It will be hard, it says, for researchers to study vertical transmission of HIV and transmission via breastfeeding in newborn babies and infants, since HIV doesn't often spread in these ways in the United States although it does in other countries. Studies may have to be conducted in other countries, which "should be conducted according to good clinical practice."

The guidance says that a safe and effective HIV vaccine in the U.S. would likely be developed and used to prevent HIV transmission by sexual or blood exposure - for which adolescents are the pediatric age group most at risk and most likely to be the subject of any clinical studies.