Wyeth Pharmaceuticals has signed a five-year, $32 million contract with the division of AIDS of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), for the development of therapeutic HIV vaccines in conjunction with researchers at the University of Pennsylvania, Duke University, and Beth Israel/Deaconess Hospital in Boston.
Through the HIV Vaccine Design and Development Teams (HVDDT) programme, Wyeth will develop and clinically evaluate novel adjuvant-enhanced plasmid DNA (pDNA) and peptide based vaccines for use in a prime-boost therapeutic regimen to help treat HIV infection, states a company release.
Previously, the NIH had awarded Wyeth two five-year contracts to evaluate two separate preventative HIV vaccine strategies.
NIH will provide the funding for direct costs associated with the design, manufacture and release of the clinical trial materials. Wyeth will contribute a minimum of $23 million of in-kind services.
"The Wyeth HIV vaccine programme is focused on the identification and clinical evaluation of vaccine approaches capable of eliciting robust and sustained anti-HIV immunological responses. We look forward to continuing our work with the NIH on a programme that has been a very gratifying scientific partnership," said Emilio A. Emini, executive vice president, Wyeth Vaccines Research and Development.
The previous two five-year contracts through the HVDDT programme totalled more than $37 million. The first contract, awarded in April 2000, focused on adjuvant-enhanced plasmid DNA (pDNA) and peptide-based vaccines. The second contract, signed in May 2002, supported the study of vesicular stomatitis virus (VSV) as a potential immunisation vehicle for the delivery of HIV immunogens. Extensive preclinical evaluations of the VSV vector system are ongoing.
Wyeth successfully completed the first contract by developing and manufacturing novel adjuvant-enhanced plasmid DNA (pDNA) and peptide-based vaccines. These prototype vaccines, which contain only a limited number of HIV antigens, are currently being evaluated in phase I clinical studies. The HIV Vaccines Trial Network (HVTN), supported by NIAID, is conducting studies in HIV-negative subjects as a first step towards determining the potential of this vaccine approach to prevent HIV infection.
In parallel, Wyeth will evaluate the vaccine approach in phase 1 clinical trials for their potential therapeutic benefit in HIV-infected individuals.