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Novavax COVID-19-Influenza Combination Vaccine Candidate Induced Antibody and T-Cell Responses Against SARS-CoV-2 and Homologous and Heterologous Influenza Strains
Trial is the first of its kind to evaluate a combined COVID-19 and influenza vaccineDose insights from Phase 1/2 trial will inform Phase 2 confirmation trial
About this update from Novavax, Inc.
[{"type":"text","content":"Trial is the first of its kind to evaluate a combined COVID-19 and influenza vaccineDose insights from Phase 1/2 trial will inform Phase 2 confirmation trial to begin in late 2022GAITHERSBURG, Md., Oct. 13, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced positive results from the Phase 1/2 clinical trial of its COVID-19-Influenza Combination (CIC) vaccine candidate. Data demonstrated the CIC vaccine's ability to generate immune responses, including both antibody and polyfunctional CD4+ T-cell (lymphocytes that help coordinate the immune response) responses against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and homologous and heterologous influenza strains. The CIC combines Novavax' COVID-19 vaccine (NVX-CoV2373) and its quadrivalent influenza vaccine candidate.\nThe CIC vaccine formulations demonstrated induction of polyfunctional CD4+ T-cell responses against both SARS-CoV-2 and homologous and heterologous influenza strains at levels comparable to stand-alone NVX-CoV2373 and quadrivalent influenza vaccine candidate reference formulations. NVX-CoV2373 has previously been shown to induce functional SARS-CoV-2–specific CD4+ and CD8+ T-cell responses, and Novavax' quadrivalent influenza vaccine candidate has previously been shown to induce cross-reactive polyfunctional CD4+ T-cell responses. T-cell responses are thought to play an important role in the immune system's control of SARS-CoV-2 and influenza virus infections (e.g., by limiting disease severity and clearing infection), and in increasing the breadth of immunity.\nThe CIC vaccine formulations generated robust antibody responses against both SARS-CoV-2 and influenza antigens, and antibody responses were modelled using a Design of Experiments (DoE) approach to help optimize future dose selection.\nThe safety and tolerability profile of the CIC vaccine was consistent with the stand-alone NVX-CoV2373 prototype vaccine and quadrivalent influenza vaccine candidate reference formulations in the trial. The CIC vaccine was found to be generally well tolerated. Serious adverse events were rare, and none were assessed as being related to the vaccine.\n\"Today's results demonstrate that our COVID-19-Influenza Combination vac...