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AIDSVAX. VaxGen.

¹Norvartis Research Institute, PO Box 80, Brunner Strasse 59, 1235 Vienna, Austria. andreas.billich@pharma.novartis.com

Current Opinion in Investigational Drugs (London, England : 2000)

|November 23, 2001

Summary

AIDSVAX, an investigational bivalent HIV vaccine, is in Phase III trials to prevent HIV infection. The vaccine has shown safety, with efficacy results pending further review.

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Area of Science:

Immunology
Vaccinology
Infectious Diseases

Background:

AIDSVAX is a bivalent vaccine comprising recombinant gp120 from two HIV types, developed for HIV infection prevention.
It is based on the earlier monovalent vaccine MNrgp120.
Two versions, AIDSVAX B/E and AIDSVAX B/B, are in Phase III trials targeting different HIV subtypes.

Purpose of the Study:

To evaluate the safety and efficacy of AIDSVAX for the potential prevention of HIV infection.

Main Methods:

Phase III clinical trials of AIDSVAX B/E in Thailand and AIDSVAX B/B in the US and Europe.
Safety and ongoing participation of volunteers are monitored by an independent data and safety monitoring board (DSMB).
Interim analysis of efficacy data is planned to determine early trial termination if the vaccine proves effective.

Main Results:

The DSMB reviewed data in April 2001 and found the vaccine to be safe, with appropriate trial conduct.
An average of 95% of volunteers continued participation in the Phase III trials.
Awaiting efficacy review scheduled for November 2001.

Conclusions:

AIDSVAX has demonstrated safety in ongoing Phase III trials.
Efficacy results are pending and will determine the future regulatory approval pathway.
Collaborative research with NIAID is exploring vaccine combinations and formulations for developing nations.

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