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A Phase 2A/B, Randomized, Observer-blinded, Placebo-controlled Study to Evaluate the Efficacy, Immunogenicity, and Safety of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M1 Adjuvant in South African Adult Subjects Living Without HIV; and Safety and Immunogenicity in Adults Living With HIV

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Trial Profile

A Phase 2A/B, Randomized, Observer-blinded, Placebo-controlled Study to Evaluate the Efficacy, Immunogenicity, and Safety of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M1 Adjuvant in South African Adult Subjects Living Without HIV; and Safety and Immunogenicity in Adults Living With HIV

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 01 Dec 2022

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At a glance

  • Drugs NVX CoV 2373 (Primary) ; Matrix M
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational; Therapeutic Use
  • Sponsors Novavax

    • Most Recent Events

    • 29 Nov 2022 According to a Novavax media release, based on supportive data from this trial, the WHO has issued an updated Emergency Use Listing (EUL) for Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a primary series of two doses in adolescents aged 12 through 17 and as a booster in adults aged 18 and older.
    • 09 Nov 2022 According to an Novavax media release, MHRA decision was based on data from Novavax' Phase 2 trial conducted in the U.S. and Australia (1,283 participants), from a separate Phase 2 trial conducted in South Africa (4,404 participants), and from the U.K.-sponsored COV-BOOST trial (2,878 participants).
    • 09 Nov 2022 According to an Novavax media release, the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (U.K.) has expanded the conditional marketing authorization (CMA)i for Nuvaxovid (NVX-CoV2373) COVID-19 vaccine as a homologous and heterologous booster dose after the primary series of Nuvaxovid (six months) or of an mRNA or adenoviral vector vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in adults aged 18 and older.
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