PI Action alerts & updates ... 2003

AIDSVax Fails to Protect

VaxGen’s Claims of Efficacy in Black & Asian Participants are Misleading & Premature

The undersigned Community-Based HIV/AIDS organizations are deeply concerned by today’s presentation of data from the phase III clinical trial of VaxGen’s HIV vaccine candidate, AIDSVAX. While the overall result demonstrates a clear and disappointing lack of efficacy, VaxGen has chosen to spotlight several subgroup analyses that were not part of the statistical evaluation described in the original trial protocol. Specifically, the company claims that the vaccine showed an efficacy rate of 67% in people categorized demographically as Black, Asian or “Other” and an even greater efficacy rate of 78% when results in Black participants were analyzed separately.

These results should be treated with extreme skepticism until subjected to a detailed, independent scientific evaluation.

We fear that VaxGen has deliberately emphasized these putatively positive findings (on the CNN Financial News Network, VaxGen CEO Lance Gordon described them as a “marvelous result”), while failing to emphasize that they are based on very small numbers of infections in a limited sample of participants. This may serve the commercial interests of the company, but it does a great and profound disservice to the HIV-affected communities who must now struggle to make sense of the press stories that the VaxGen release has generated.

The Numbers Game: Reasons to Emphasize Uncertainty
The smaller the sample size, the less certain the results. Among Black trial participants, there were 9 infections out of 111 placebo recipients compared to 4 infections out of 203 vaccine recipients. A small difference in these rates would erase the statistical significance of this finding. VaxGen strongly implies this result is meaningful by stating that there is a less than 2% possibility that it occurred by chance; however, that does not prove that the explanation lies with receipt of the vaccine.
When considered separately, differences in the infection rates between placebo and vaccine recipients among Asian participants and those categorized demographically as “Other” were not statistically significant. Only the arbitrary grouping together of these demographic categories with Black participants allowed VaxGen to claim a 67% reduction in infection rate “among ethnic minorities, other than Hispanic individuals” (VaxGen Press Release, 2/24/03).
Women in the trial experienced a lower infection rate than men, and women were overrepresented among the non-White, non-Hispanic populations in the trial. A breakout of the trial results for women in the different demographic groups has not yet been presented.
While the desperate need for an HIV vaccine is clear, especially among the underserved communities that bear the brunt of the pandemic, hope cannot take flight on the gossamer wings of dubious subgroup analyses. It is critical that the scientific leads that may be contained in the VaxGen data are vigorously pursued, but the uncertainty associated with the results presented today must be clearly articulated.

We call on VaxGen to submit the findings to a panel of outside experts assembled by the National Institutes of Health for a full examination of the data and report to the public within 30 days.

Organizations
AIDS Treatment Data Network
AIDS Vaccine Advocacy Coalition (AVAC)
AIDS Action Baltimore
AIDS Community Research Initiative of America (ACRIA)
Being Alive: The People With HIV/AIDS Action Coalition of Los Angeles
Center for AIDS: Hope & Remembrance Project, Houston, Texas
Community HIV/AIDS Mobilization for Power (CHAMP)
Deutsche AIDS-Hilfe e.V., Germany
Foundation for Integrative AIDS Research (FIAR)
Gay Men’s Health Crisis (GMHC)
HIV/Hepatitis C in Prison Committee of California Prison Focus
IFARA (International Foundation for Alternative Research in AIDS)
Latino Commission on AIDS
National AIDS Treatment Advocacy Project (NATAP)
Project Inform
Projekt Information e.V., Germany
Test Positive Aware Network
Treatment Action Group (TAG)
Wyoming: Positives For Postives

Individuals
Mauro Guarinieri: European AIDS Treatment Group
Michael Marco, Washington, DC
Walt Senterfitt, Board Member and Advocacy Chair, Being Alive, Los Angeles
Matt Sharp, Chicago, AIDS Treatment Activist Coalition
Tracy Swan, New York, NY
Emmanuel Trenado, Paris, France
Ulrich Wuerdemann, HIVlife.de, Germany

Contacts:
AVAC
Huntly Collins
212-367-1051 or 215-248-3452
Cell: 267-226-8480
huntly@avac.org; huntlycollins@att.net

GMHC
Gregg Gonsalves
212-367-1169
greggg@gmhc.org

Project Inform
Brenda Lein
415-558-8669
blein@projectinform.org
TAG

Richard Jefferys
212-253-7922
Cell: 646-554-3963
richard.jefferys@verizon.net