AIDSVax: Fails to prevent HIV infection

February 2003     View PDF

Preliminary results from VaxGen’s study of the preventive HIV vaccine, AIDSVax were announced last night, 23 February 2003. The study showed that the AIDSVax vaccine was not effective in preventing HIV infection, not even to a small degree as had been previously speculated.

After finding an overall negative conclusion, the company looked at vaccine responses in subgroups composed of racial/ethnic minorities. Based on this subgroup exploration, the company claims the vaccine might prove beneficial in some racial subgroups, including Asians and Black people, but only if Hispanics were specifically excluded from the analysis. The study, however, was not designed or powered statistically to evaluate such differences between racial groups, rendering any claims of statistically significant results questionable. The company insisted that the subgroup analyses were planned in advance with the FDA. However this is not the same thing as saying that the subgroups were sized and powered sufficiently to reach any conclusions. The preliminary report leaves it impossible to assess whether or not the data actually supports the claim, no matter what the company says. Given the level of expertise and experience of the scientists at VaxGen, it can only be assumed that the holes left in understanding these data are deliberate. These results are discussed in greater detail below.