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news.AlphaVax has announced an initial analysis of data from a placebo-controlled, randomized, double-blind, single center Phase I clinical trial of a cytomegalovirus vaccine that is based on its platform alphavirus replicon vector technology.
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AlphaVax’s cytomegalovirus (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 the company’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.
Robert Olmsted, vice president of research of AlphaVax, said: “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.”