Juvaris BioTherapeutics, Inc., a biotechnology company developing adjuvanted vaccines for infectious diseases, today announced that it has begun enrolling patients in a Phase 2 clinical trial of its lead compound, JVRS-100, as an adjuvant for seasonal influenza vaccines in the elderly population.
“There is a significant need to improve the efficacy of seasonal influenza vaccines for elderly individuals given that current vaccines are effective in only a fraction of this population,” said Tom Monath, M.D., acting Chief Medical Officer of Juvaris. “Results from our first clinical trial demonstrated that JVRS-100 enhances both antibody and T-cell mediated immune responses and thus holds potential for the development of improved influenza protection, especially in a population more susceptible to complications from influenza infection. Moreover, this was the first time an adjuvant has shown the ability to induce CD8+ cytotoxic T-cells in humans. This finding has broad implications for development of new vaccines against infectious diseases and cancer.”
The randomized, double-blind, controlled trial will enroll approximately 472 subjects 65 years and older and compare antibody and T-cell responses to trivalent inactivated influenza vaccine administered with and without the JVRS-100 adjuvant. Primary objectives of the study are to assess its safety, tolerability and ability to enhance immune responses (both antibody and cellular immunity) to the influenza vaccine. The study is also intended to define the most effective dose of the JVRS-100 adjuvant and will evaluate three different doses. Enrollment will take place at six centers across the United States.