AlphaVax Announces Initial Analysis of Data From CMV Phase 1 Clin...( RESEARCH TRIANGLE PARK N.C. April...),Health

RESEARCH TRIANGLE PARK, N.C., April 17 /PRNewswire/ -- AlphaVax, Inc. announced today an initial analysis of data from a Phase I clinical trial of a cytomegalovirus (CMV) vaccine that is based on its platform alphavirus replicon vector technology.

The trial is a placebo-controlled, randomized, double-blind, single center study involving 40 healthy, 18-40 year old, CMV-negative volunteers. The trial is being conducted by David I. Bernstein, M.D., Director of Infectious Diseases at the Cincinnati Children's Hospital Medical Center in Ohio. AlphaVax's CMV vaccine was administered three times over six months at one of two dosage levels, and safety and immunogenicity data were obtained from all volunteers following each dose of the vaccine. Confirming AlphaVax's earlier reported experience in humans with its prototype HIV and influenza vaccine candidates, the CMV vaccine has proven to be safe and very well tolerated. While the study remains blinded, it is clear that a majority of the subjects developed substantial antibody or T cell responses to all three CMV antigens in the vaccine. Preliminary results suggest that both the CD4 and CD8 cells appear to be multifunctional T cells, similar to the type that has recently been associated with protective responses.

"We are very pleased with these results as they clearly demonstrate the vaccine's ability to stimulate readily detectable immune responses to all three vaccine-expressed antigens and at both dosage levels. It is these types of responses, both cellular and humoral, that will be required for an effective vaccine against CMV infection and disease," said Dr. Robert Olmsted, Vice President of Research.

The vaccine used in this trial is bivalent as it contains two replicon vectors which are derived from an attenuated alphavirus. One replicon vector expresses the pp65 and IE1 genes of CMV and the second the CMV gB glycoprotein gene. Virus-like particles containing the replicon vectors were produ
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