Novavax to Participate in OCTAVE-DUO Study to Evaluate Third Dose of Vaccine 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.
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