AIDSVAX. VaxGen

AIDSVAX, a bivalent vaccine consisting of a preparation of recombinant gp120 from two types of HIV, is being developed by VaxGen for the potential prevention of HIV infection [274573]. Two versions of the vaccine are in phase III trials: AIDSVAX B/E, in phase III trials in Thailand, stimulates production of antibodies to HIV subtypes common to South and Southeast Asia, and countries of the Pacific Rim; and AIDSVAX B/B, in phase III trials in the US and Europe, stimulates production of antibodies to HIV subtypes that are found in the Americas, Europe, the Caribbean and Australia [314365], [397186]. The bivalent vaccine is based on an earlier monovalent vaccine, MNrgp120 (Genetech Inc/VaxGen Inc) [274573], [356845]. In April 2001, the independent data and safety monitoring board (DSMB) reviewed data from the trials and indicated that the vaccine appeared safe and that the trials were being conducted appropriately. VaxGen has disclosed that an average of 95% of volunteers continue to participate in the phase III trials. The DSMB was scheduled to conduct its review in November 2001, to examine the efficacy of AIDSVAX in the prevention of HIV infection. VaxGen would halt the trial early if the interim analysis shows the vaccine to be effective. The company would then begin the process of applying for regulatory approval. If the interim analysis proves inconclusive, the trial would proceed to its scheduled conclusion in the fourth quarter of 2002 [386730], [405696]. In August 1998, a collaborative research agreement was signed with the National Institute of Allergy and Infectious Diseases (NIAID). This includes research on combinations of AIDSVAX and other NIAID vaccines and research for new formulations suitable for developing nations [295166].