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

NCT04537208 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 441

Last updated 2025-09-17

Study results available
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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.

Conditions

  • COVID-19 (Healthy Volunteers)

Interventions

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

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-03
Primary Completion
2021-11-19
Completion
2021-11-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04537208 on ClinicalTrials.gov