Juvaris BioTherapeutics Announces Positive Data from Clinical Trial of JVRS-100 Adjuvanted Flu Vaccine
News Jan 09, 2009
Juvaris BioTherapeutics, Inc. has announced positive results from a Phase 1 clinical trial of its lead compound, JVRS-100, as an adjuvant for influenza vaccines.
Results from the randomized, double blind, controlled trial demonstrated positive effects of the JVRS-100 adjuvant co-administered with a commercial influenza vaccine compared to vaccine alone. Increased antibody responses measured by serum hemagglutination inhibition (HAI) and neutralizing antibody titers were observed in subjects receiving JVRS-100 and vaccine versus vaccine alone in study participants 28 days post-vaccination.
HAI and neutralization titers are the accepted correlates of increased protection against illness after exposure to influenza. JVRS-100 administered at the most efficacious dose was well tolerated, with no additional side effects over those associated with influenza vaccine alone. The trial enrolled 128 healthy adult subjects 18 to 49 years of age.
“It is very encouraging to see proof-of-concept in the clinic with this novel adjuvant, and the wide margin of safety indicates that JVRS-100 may be effective as a means to not only improve existing vaccines, but also to develop novel preventative and therapeutic vaccines against diseases for which vaccination has not been possible,” said Grant E. Pickering, President and CEO of Juvaris.
“The promising results from this clinical trial indicate that JVRS-100 can increase the immune response generated by existing vaccines without additional toxicity,” said Thomas P. Monath, MD, acting chief medical officer at Juvaris.
“We look forward to advancing JVRS-100 into Phase 2 clinical development in the elderly patient population and into trials with a pandemic (avian) influenza vaccine. There are profound needs for adjuvants to improve vaccine efficacy, and these study results will accelerate development of other novel vaccines incorporating the JVRS-100 adjuvant to address previously untreatable infectious diseases,” Monath said.