Study of Recombinant Protein Vaccine Formulations Against COVID-19 in Healthy Adults 18 Years of Age and Older

COVID-19 (Healthy Volunteers) Clinical Trial

Official title:
Immunogenicity and Safety of SARS-CoV-2 Recombinant Protein Vaccine Formulations (With or Without Adjuvant) in Healthy Adults 18 Years of Age and Older

Status Completed

Clinical Trial Summary

The primary objectives of the study were: - To describe the neutralizing antibody profile at Day 1, Day 22, and Day 36 of each study intervention group. - To describe the safety profile of all participants in each age group and each study intervention group up to 12 months post-last injection. The secondary objectives of the study are: - To describe binding antibody profile at Day 1, Day 22, Day 36, Day 181 (Cohort 1) or Day 202 (Cohort 2), and Day 366 (Cohort 1) or Day 387 (Cohort 2) of each study intervention group. - To describe the neutralizing antibody profile at Day 181 (Cohort 1) or Day 202 (Cohort 2) and at Day 366 (Cohort 1) and Day 387 (Cohort 2) of each study intervention group. - To describe the occurrence of virologically-confirmed coronavirus disease (COVID-19)-like illness and serologically-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. - To evaluate the correlation / association between antibody responses to SARS-CoV-2 Recombinant Protein and the risk of virologically-confirmed COVID-19-like illness and/or serologically-confirmed SARS-CoV-2 infection.

Clinical Trial Description

The duration of each participant's participation in the study was approximately 365 days (Cohort 1) and 386 days (Cohort 2) post last injection. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04537208
Study type	Interventional
Source	Sanofi
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	September 3, 2020
Completion date	November 19, 2021

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT04742738` - Safety and Immunogenicity Study of SARS-CoV-2 Nanoparticle Vaccine (GBP510) Adjuvanted With Aluminum Hydroxide (COVID-19)	Phase 1/Phase 2
Active, not recruiting	`NCT04750343` - Safety and Immunogenicity Study of SARS-CoV-2 Nanoparticle Vaccine (GBP510) Adjuvanted With or Without AS03 (COVID-19)	Phase 1/Phase 2
Completed	`NCT04760743` - Safety and Immunogenicity of a SARS-CoV-2 Vaccine (NBP2001) in Healthy Adults (COVID-19)	Phase 1