Novavax to Participate in OCTAVE-DUO Study to Evaluate Third Dose of Vaccine in Participants with Impaired Immune Systems


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OCTAVE-DUO

 

GAITHERSBURG, Md., Aug. 25, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that Novavax' recombinant nanoparticle protein vaccine candidate is being studied in OCTAVE-DUO, now underway in the UK to evaluate the safety and immunogenicity of a third COVID-19 vaccine dose in participants with impaired immune systems.  

Funded by the UK government's Vaccines Taskforce and the UK Research and Innovation (UKRI), the study is being led by the University of Glasgow and University of Birmingham. It is a follow-on to OCTAVE (Observational Cohort Trial -T-cells Antibodies and Vaccine Efficacy in SARS-CoV-2), which evaluated the immune response to COVID-19 vaccines in participants with impaired immune systems due to cancer, inflammatory arthritis, kidney or liver diseases, or a stem cell transplant.

As part of OCTAVE-DUO, 320 participants with lymphoid malignancies from OCTAVE and similar studies who demonstrated low or no response to two doses of a primary COVID-19 vaccine regimen will be randomly assigned to receive a third vaccine dose from one of three manufacturers at least 14 days after completing the initial 2-dose regime. The individuals may receive the same vaccine as the first two doses or one from another manufacturer. Of these participants, one third will be administered Novavax' recombinant nanoparticle protein-based COVID-19 vaccine, NVX-CoV2373.

"We expect the results of this study to be particularly helpful to better understanding how our vaccine might work as a heterologous third dose in immunocompromised individuals," said Gregory M. Glenn, M.D., President of Research and Development, Novavax. "As the pandemic continues to surge, the ability to have a flexible approach to vaccine regimens will be important for both medically vulnerable individuals as well as to achieving population-wide coverage."

Participants will be evaluated for changes in vaccine-specific immune responses and any adverse events, with findings expected later in 2021. The Medicines and Healthcare products Regulatory Agency (MHRA) and Joint Committee on Vaccination and Immunization (JCVI) will review the results to further inform the use of vaccination in immunocompromised populations.

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) 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. In preclinical studies, NVX-CoV2373 induced antibodies that blocked the binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response in Phase 1/2 clinical testing.

NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall; and the PREVENT-19 trial in the U.S. and Mexico that demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall. It is also being tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b trial in South Africa that demonstrated 55% efficacy overall in HIV-negative participants and 48.6% efficacy against a newly emerging escape variant first described in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.

NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.

About Matrix-M™ Adjuvant

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.

About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

SOURCE Novavax, Inc.

Posted: August 2021

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