Development/Production-Alternative Serotype HIV Recombinant Adenoviral Vaccine

National Institute Of Allergy And Infectious Diseases

Investigators

Linked publications & trials

Abstract

This project is designed to prepare a GMP quality investigational alternative serotypes (other than Ad5) HIV vaccine and complete the preclinical and laboratory studies needed to begin a clinical trial. The first clinical trial is a Phase I study to examine tolerability, dose, and immune response of the HIV vaccine. The hypothesis is that this vaccine will be safe for human administration and elicit immune responses to HIV. Clinical materials have been manufactured in compliance with current Good Manufacturing Practices (cGMP) and released for use in Phase I clinical trials