Novavax’s Phase II trial is evaluating various vaccine candidates. Credit: Arek Socha from Pixabay.

Novavax has reported positive Phase II topline results evaluating its Covid-Influenza Combination (CIC), stand-alone influenza and high-dose Covid vaccine candidates.

Designed to evaluate the safety and immunogenicity of different formulations of the vaccines, the dose-confirming, observer-blinded, randomised study enrolled adults aged 50 to 80 years.

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The CIC vaccine consists of a recombinant protein-based Covid vaccine, quadrivalent influenza vaccine along with a patented saponin-based Matrix-M adjuvant.

All three vaccine candidates demonstrated a reassuring preliminary safety profile with reactogenicity compared to authorised comparators.

Haemagglutination inhibition (HAI) responses for the stand-alone influenza vaccine candidate were 31 to 56% higher for all four influenza strains against Fluad, and 44 to 89% higher for A strains compared to Fluzone HD.

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For the CIC vaccine candidate, anti-S IgG and neutralisation responses achieved levels that were found in Phase III trial with the prototype vaccine of Novavax.

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The reactogenicity profile also remained constant as the adjuvant or antigen dose was increased and all the three candidates were well-tolerated.

Novavax Research and Development president Filip Dubovsky said: “The reactogenicity results support our previous observations that this technology is well suited for combination vaccines because large amounts of antigen can be incorporated without impacting tolerability.

 “The immune responses we observed were robust, and the data we have shared today significantly increase the probability of Phase III success.”