NCT04537208

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

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 441 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• COVID-19 (Healthy Volunteers)

Interventions

Type	Name	Description
BIOLOGICAL	CoV2 preS dTM-AF03 (low-dose)	Pharmaceutical form: liquid; route of administration: intramuscular injection
BIOLOGICAL	CoV2 preS dTM-AF03 (high-dose)	Pharmaceutical form: liquid; route of administration: intramuscular injection
BIOLOGICAL	CoV2 preS dTM-AS03 (low-dose)	Pharmaceutical form: liquid; route of administration: intramuscular injection
BIOLOGICAL	CoV2 preS dTM-AS03 (high-dose)	Pharmaceutical form: liquid; route of administration: intramuscular injection
BIOLOGICAL	CoV2 preS dTM (high-dose) without adjuvant	Pharmaceutical form: liquid; route of administration: intramuscular injection
BIOLOGICAL	Placebo (0.9% normal saline)	Pharmaceutical form: liquid; route of administration: intramuscular injection

Timeline

• Start date: 2020-09-03
• Primary completion: 2021-11-19
• Completion: 2021-11-19
• First posted: 2020-09-03
• Last updated: 2025-09-17
• Results posted: 2023-06-22

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study