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news.Immunovaccine, a clinical stage vaccine and immunotherapy company, announced that it has enrolled the first healthy adult volunteer in a Phase I clinical study of its respiratory syncytial virus (RSV) vaccine.
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The Phase 1 study will evaluate the safety and immune response profile of the DPX-RSV vaccine candidate in healthy adults. The study, conducted at the Canadian Center for Vaccinology (CCfV) in Halifax and led by Joanne Langley, M.D., will enroll 40 healthy adults who are 50 to 64 years of age.
The vaccine will be tested at two different vaccine dose levels and study investigators will assess the vaccine’s safety and immune response profile following one or two immunizations of each dose level. Immunovaccine and the Canadian Institutes of Health Research (CIHR) are co-funding the trial.
"We are pleased to initiate this clinical trial in older adults, a largely underserved population for RSV," said Dr. Langley. "By using a vaccine candidate formulated in DepoVax, we are hoping to generate strong immune responses in older individuals."
RSV is a respiratory virus that infects the lungs and breathing passages and most commonly affects the elderly, infants and patients with compromised immune systems.
It can be severe in some patients and is the second most commonly identified cause of viral pneumonia in older persons, next to influenza. Globally, it is estimated that 64 million cases of RSV infection occur annually in all age groups, with 160,000 deaths.
The Immunovaccine RSV vaccine candidate contains a unique target, a viral protein expressed on the surface of infected cells. Professor emeritus Walter Fiers and Xavier Saelens, Ph.D. at Ghent University discovered the target, which was exclusively in-licensed to Immunovaccine for use in DPX-RSV from VIB, a non-profit life science research institute based in Flanders, Belgium. It is believed that an immune response to this target will limit the severity of RSV infection in susceptible patient populations.
"We developed this novel human RSV vaccine candidate in our laboratory at Ghent University and VIB, and published those findings in an international scientific journal in 2014," said Dr. Saelens. "We are very excited to see Immunovaccine engage in this clinical trial to further advance the vaccine."
"Currently, there is no vaccine available for the prevention of RSV, creating both a significant unmet medical need and a large vaccine market," stated Marc Mansour, Ph.D., Immunovaccine Chief Executive Officer. "A novel and effective vaccine formulated in a strongly immunogenic platform like DepoVax offers great potential for success, and we look forward to the data that will be generated in this clinical trial."
DepoVax is a patented formulation that provides controlled and prolonged exposure of antigens plus adjuvant to the immune system, resulting in a strong, specific and sustained immune response with the potential for single-dose effectiveness.
The DepoVax platform is flexible and can be used with a broad range of target antigens for preventative or therapeutic applications. The technology is designed to be commercially scalable, with the potential for years of shelf life stability.