Novavax announced the initiation of a Phase 2 trial for its COVID-19-Influenza Combination (CIC) and influenza stand-alone vaccine candidates.
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The dose-confirming trial will evaluate the safety and effectiveness (immunogenicity) of different formulations of the CIC and influenza vaccine candidates in adults aged 50 through 80.
The randomized, observer-blinded trial will assess a combination of Novavax' recombinant protein-based COVID-19 vaccine (NVX-CoV2373), quadrivalent influenza vaccine candidate, and patented saponin-based Matrix-M adjuvant.
Primary and secondary objectives of the study are to assess the safety, tolerability, and immune responses to various formulations of the CIC and influenza vaccine candidates.
The Phase 2 dose-confirmation trial will be conducted in two parts and seek to enroll a total of approximately 2,300 participants across multiple sites located in Australia and New Zealand.
Initial results of the trial are expected mid-year 2023. These data will inform the Phase 3 trials for both influenza stand-alone and COVID-19-influenza combination candidates.
NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.
The vaccine was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein and is formulated with Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.
The vaccine is packaged as a ready-to-use liquid formulation and 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 NVX-CoV2373 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.
Novavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response. ■