Novavax announced positive results from the Phase 1/2 clinical trial of its COVID-19-Influenza Combination (CIC) vaccine candidate.
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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.
The 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.
The 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.
The 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.
The DoE modeling-based approach used to design the trial enabled more powerful fine-tuning of dose selection of both the COVID-19 and influenza antigens for further development compared to traditional approaches. These dose insights will inform the Phase 2 confirmation trial to begin by the end of 2022.
Both protein-based vaccines used in the trial were formulated with Novavax' patented saponin-based Matrix-M adjuvant, which is designed to enhance the immune response and stimulate high levels of neutralizing antibodies.
Trial results were presented on October 13 at the World Vaccine Congress (WVC) Europe 2022. Previous initial trial results were presented at WVC in April 2022.
The Phase 1/2 CIC vaccine trial evaluated a combination of Novavax' recombinant protein-based NVX-CoV2373, influenza vaccine candidate, and patented saponin-based Matrix-M adjuvant in a single formulation. The trial evaluated the safety, tolerability, and immune response to the CIC in 642 healthy adults aged 50 to 70.
Participants were either previously infected with the SARS-CoV-2 virus that causes COVID-19 or vaccinated with an authorized vaccine at least eight weeks prior to enrollment. All participants were randomly assigned to cohorts to evaluate multiple formulations and were dosed on Day 0 and again at Day 56. The trial was conducted in Australia at 10 sites.
The vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart.
The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.
Novavax has established partnerships for the manufacture, commercialization, and distribution of the vaccine worldwide. Existing authorizations leverage Novavax' manufacturing partnership with Serum Institute of India, the world's largest vaccine manufacturer by volume.
They will later be supplemented with data from additional manufacturing sites throughout Novavax' global supply chain. ■