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SARS-CoV-2 rS

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

Ensayo de NOVAVAX INC en COVID-19.

Más ensayos de: COVID-19.

Fase

Fase 2

Estado

Completado

Participantes

4.422

previstos

Centros

14

Fin del objetivo primario

dic 2021

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en ago 2020.

Qué mide

Cohort 1: HIV- Participants with Symptomatic Mild, Moderate, or Severe COVID-19 (del registro, en inglés) (del dia 28 al dia 386)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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.

Más ensayos de NVAX

Todos los de NVAX, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04533399), actualizada en feb 2022.