NIH Details Plans for Analyzing VaxGen Phase III Data

By Emily Bass

At the 24 June meeting of the National Institutes of Health (NIH) AIDS Vaccine Research Working Group, Peggy Johnston, head of the NIH AIDS vaccine research effort, outlined a three-pronged plan for involvement of NIH and the Centers for Disease Control (CDC) in VaxGen’s completed and ongoing Phase III trials.

The plan emerged after VaxGen released data from its US-European Phase III study and made the controversial claim that the vaccine showed efficacy in non-white minority groups. 

 

In the plan’s ongoing first phase, an independent team will re-analyze existing data, looking at factors such as race, risk category and the viral strains that infected volunteers. A second team is discussing potential additional analyses of blood samples, such as broader characterization of antibody responses, and HLA typing. The goal of the third component is “to ensure completion” of the ongoing Phase III trial in Thailand, Johnston said. To achieve this, NIH, CDC and an as-yet unnamed donor will work on statistical analysis of data with Thai investigators and VaxGen. 

Johnston said that NIH developed this strategy after VaxGen expressed reluctance to invest additional funds in the Thai trial. At the same meeting, VaxGen representative Marc Gurwith said that the company—which already has many samples from the nearly-completed Thai study—was collaborating fully with the independent data analysis. At press time, precise details of the NIH-initiated consortia, and of VaxGen’s role, had not been specified.