GenVec, Inc. announced that the company's scientists and its collaborators have presented encouraging data from malaria vaccine studies using the company's adenovector technologies at the Malaria Vaccines for the World Conference held at the Royal Society of Medicine in London, U.K, recently.
Data from the first cohort of volunteers in a phase I/II clinical trial sponsored by the Naval Medical Research Center (NMRC) and the US Military Malaria Vaccine Program showed this malaria vaccine candidate to be well tolerated and that it induced strong Tcell responses against the target antigens in all volunteers.
The results were presented by scientists from NMRC. This vaccine, produced using GenVec's proprietary 293-ORF6 cell line and associated manufacturing process, is designed to provide protection against both the liver and blood stages of the parasite. NMRC is now enrolling volunteers to assess the safety and immunogenicity of a higher dose of the vaccine. After establishing that the vaccine is safe and well tolerated at the optimal dose, the next phase will evaluate the protective effects of the vaccine after malaria challenge. The ability to safely challenge human volunteers provides a unique opportunity to assess efficacy of candidate vaccines prior to field trials, the company said.
According to a company press release, pre-clinical data under a separate GenVec collaboration with the PATH malaria vaccine initiative (MVI) and the NMRC were also presented by scientists from NMRC at the conference. A new malaria vaccine candidate that includes five antigens from both blood and liver stages of the parasite showed robust T-cell and antibody responses to all antigens in animals following delivery of the multivalent adenovectors. These findings are important because GenVec's adenovectors induced high levels of functional antibodies against the blood-stage forms of the malaria parasite.
As a result of these observations, two multivalent vectors have been selected for clinical development of new malaria vaccines. In addition, GenVec scientists presented results of preclinical studies using new Ad5- based vaccine vectors designed to avoid pre-existing antibodies and may be used in prime-boost settings designed to boost the immune response against pathogens.
"The results from these studies are encouraging and support the use of our adenovector technologies in developing effective malaria vaccines. We are excited by the progress of our collaborations and the potential for these programs to advance into later-stage clinical trials," said, Joseph L. Bruder, Ph.D., director of vector and vaccine, GenVec.
The vaccine used in the clinical trial was developed in collaboration with the NMRC and the clinical trial is being conducted by NMRC at their clinical trials center, located on the campus of the National Naval Medical Centre in Bethesda, MD, 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 Program, the press release said.
The malaria program at the Naval Medical Research Centre (NMRC) as part of the joint U.S. Military Malaria Vaccine Program conducts basic and applied research, development, and clinical evaluations to enhance the health, safety and readiness of soldiers, sailors, airmen and marines in the effective performance of peacetime and contingency missions. NMRC also provides research and development.