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
The purpose of this study is 2-fold: 1) to evaluate the efficacy, safety, and immunogenicity of SARS-CoV-2 rS with Matrix-M1 adjuvant in serologically naïve (to SARS-CoV-2) healthy human immunodeficiency virus (HIV)-negative adult subjects (Cohort 1 – HIV-negative) and 2) to evaluate the safety and immunogenicity of SARS-CoV-2 rS with Matrix-M1 adjuvant in serologically naïve (to SARS-CoV-2) medically stable HIV-positive adult subjects (Cohort 2 – HIV-positive). The study will be conducted at anticipated high COVID-19 transmission areas in South Africa expected to occur from July 2020 and onwards during the Southern Hemisphere winter and beyond. The information provided in this study will inform progression of development efforts to take the vaccine forward in an emergency use authorization setting and/or for Phase 3 efficacy or effectiveness study(ies).
To evaluate the efficacy of SARS-CoV-2 rS with Matrix-M1 adjuvant compared to placebo on the occurrence of symptomatic mild, moderate, or severe confirmed COVID-19 as demonstrated by qualitative polymerase chain reaction (PCR) in serologically naïve (to SARS-CoV-2) healthy HIV-negative adult subjects.
To evaluate the efficacy of SARS-CoV-2 rS with Matrix-M1 adjuvant compared to placebo on the occurrence of symptomatic moderate or severe confirmed COVID-19 as demonstrated by qualitative PCR in serologically naïve (to SARS-CoV-2) healthy HIV-negative adult subjects.
To accumulate and describe the safety experience for SARS-CoV-2 rS with Matrix-M1 adjuvant based on solicited short-term reactogenicity across a broad age spectrum (by toxicity grade) and by adverse event (AE) profile for vaccination through Day 35 in healthy HIV-negative adult subjects regardless of baseline serostatus and stratified by baseline serostatus. .
A minimum of approximately 3,200 to a maximum of approximately 4,404 subjects aged ≥ 18 to < 85 years will be randomized in a blinded fashion at up to 15 sites across South Africa.
Latest Update: 15 February 2021
For more about Novovax 2019nCOV501 please email email@example.com