GenVec, Inc. announced that they are collaborating with the Naval Medical Research Center (NMRC) in Silver Spring, Maryland, to conduct the first clinical study of an experimental malaria vaccine based on the company's gene delivery and cell culture manufacturing technologies for the production of recombinant adenovirus vaccine vectors.
Under sponsorship from the United States Army Medical Materiel Development Activity (USAMMDA), and with financial support from the US Agency for International Development, the Congressionally Directed Peer Review Medical Program, and the Military Infectious Diseases Research Programme, NMRC will initiate this FDA-approved study at their clinical trials centre, located on the campus of the National Naval Medical Center in Bethesda.
GenVec has been collaborating with the NMRC for the past four years to develop adenovector-based malaria vaccine candidates. The vaccine now undergoing clinical testing consists of two adenovectors, each encoding a different antigen from the protozoal parasite Plasmodium falciparum. The vaccine is designed to stimulate T-cell and antibody immune responses and attack both the liver and blood stages of this complex parasite. This approach of eliciting a broad-spectrum immune response and attacking multiple stages of the malaria parasite's life cycle has shown promise in preclinical studies.
The first (safety) phase of the study will evaluate the safety and immunogenicity of two vaccine doses in healthy volunteers. After safety evaluation and confirmation of the optimal dose, the second (challenge) phase of the study will evaluate the protective effects of the vaccine following exposure to malaria. The ability to safely challenge human volunteers provides a unique opportunity for assessing the efficacy of candidate vaccines prior to the initiation of field trials.
Paul Fischer, Ph.D., president and CEO of GenVec, stated: "This study represents an important step forward in our collaboration with the Naval Medical Research Center that, if successful, will help validate our approach to developing novel vaccines against malaria, which remains one of the world's most prevalent and serious infectious diseases. We look forward to seeing the initial results of this study later this year."