NCT04533399

A Study Looking at the Effectiveness and Safety of a COVID-19 Vaccine in South African Adults

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: Phase 2
• Study type: Interventional
• Enrollment: 4,422 (actual)
• Sponsor: Novavax · Industry
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Accepted

Summary

This is a study to evaluate the effectiveness and safety of a coronavirus disease 2019 (COVID-19) vaccine called SARS-CoV-2 rS with Matrix-M1 adjuvant in a minimum of approximately 2,960 to a maximum of approximately 4,164 healthy HIV-negative (HIV-) adult participants and in approximately 240 medically stable HIV-positive (HIV+) adult participants in up to 15 sites across South Africa. A vaccine causes the body to have an immune response that may help prevent the infection or reduce the severity of symptoms. An adjuvant is something that can make a vaccine work better. This study will look at the protective effect, body's immune response, and safety of SARS-CoV-2 rS with Matrix-M1 adjuvant in these study populations. Participants in the study will randomly be assigned to receive SARS-CoV-2 rS with Matrix-M1 adjuvant or placebo. Each participant in the study will receive a total of 2 intramuscular injections over the course of the study.

Conditions

• SARS-CoV-2 Infection
• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 rS/Matrix-M1 Adjuvant	Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) on Days 0 and 21.
OTHER	Placebo	Alternating intramuscular (deltoid) injections of placebo (0.5 mL) on Days 0 and 21.

Timeline

• Start date: 2020-08-17
• Primary completion: 2021-12-07
• Completion: 2022-01-19
• First posted: 2020-08-31
• Last updated: 2022-02-17

Locations

14 sites across 1 country: South Africa

Regulatory

• FDA-regulated drug study