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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Aged 18 years of age or older on the day of inclusion. - Informed consent form had been signed and dated. - Able to attend all scheduled visits and complied with all study procedures.

Exclusion Criteria

  • Participant was pregnant, or lactating, or of childbearing potential and not used an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 12 weeks after the last vaccination. To be considered of non-childbearing potential, a female was post-menopausal for at least 1 year or surgically sterile. - Receipt of any vaccine in the 30 days preceding the first study vaccination or planned receipt of any vaccine in the 30 days following the last study vaccination except for influenza vaccination, which might be received at least 2 weeks before and a minimum of 2 weeks after study vaccines. - Prior administration of a coronavirus vaccine SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome). - Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). - History of SARS-CoV-2 infection, confirmed either clinically, serologically, or microbiologically - Chronic illness or condition considered to potentially increase the risk for severe COVID illness or that, in the opinion of the Investigator, was at a stage where it might interfere with study conduct or completion. - Receipt of any therapy known to had in-vitro antiviral activity against SARS-CoV-2 within 72 hours prior to the first blood drew. - Health care workers provided direct participant care for COVID-19 participants. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This was a parallel group prevention study. Participants from 2 age groups (adults 18 through 49 years of age and adults 50 years of age and older) received either 1 injection (Cohort 1) or 2 injections (Cohort 2) of study vaccine or placebo control. As a precautionary step, a sentinel safety cohort of 6 participants (younger adults only) within each dosing group from Cohort 1 was enrolled. An early safety data review was performed, including evaluation of safety data and laboratory measures to Day 9. Upon acceptable safety demonstrated from unblinded data review by limited members of the Sponsor Study Team, the remaining participants were enrolled simultaneously.
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Participants, outcome assessors, Investigators, laboratory personnel, and the majority of Sponsor study staff will be blinded to vaccine group assignment; injection schedule will be unblinded and those preparing/administering the study interventions will be unblinded.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1: Group 1: SARS-CoV-2 vaccine LD + AF03 		Participants received a single intramuscular (IM) injection of SARS-CoV2 vaccine low-dose (LD) formulation along with adjuvant AF03 on Day 1.
  • Biological: CoV2 preS dTM-AF03 (low-dose)
    Pharmaceutical form: liquid; route of administration: intramuscular injection
Experimental
Cohort 1: Group 2: SARS-CoV-2 vaccine LD + AS03 		Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
  • Biological: CoV2 preS dTM-AS03 (low-dose)
    Pharmaceutical form: liquid; route of administration: intramuscular injection
Experimental
Cohort 1: Group 3: SARS-CoV-2 vaccine HD + AF03 		Participants received a single IM injection of SARS-CoV2 vaccine high-dose (HD) formulation along with adjuvant AF03 on Day 1.
  • Biological: CoV2 preS dTM-AF03 (high-dose)
    Pharmaceutical form: liquid; route of administration: intramuscular injection
Experimental
Cohort 1: Group 4: SARS-CoV-2 vaccine HD + AS03 		Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
  • Biological: CoV2 preS dTM-AS03 (high-dose)
    Pharmaceutical form: liquid; route of administration: intramuscular injection
Placebo Comparator
Cohort 1: Group 5: Placebo 		Participants received an IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
  • Biological: Placebo (0.9% normal saline)
    Pharmaceutical form: liquid; route of administration: intramuscular injection
Experimental
Cohort 2: Group 6: SARS-CoV-2 vaccine LD + AF03 		Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
  • Biological: CoV2 preS dTM-AF03 (low-dose)
    Pharmaceutical form: liquid; route of administration: intramuscular injection
Experimental
Cohort 2: Group 7: SARS-CoV-2 vaccine LD + AS03 		Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
  • Biological: CoV2 preS dTM-AS03 (low-dose)
    Pharmaceutical form: liquid; route of administration: intramuscular injection
Experimental
Cohort 2: Group 8: SARS-CoV-2 vaccine HD + AF03 		Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
  • Biological: CoV2 preS dTM-AF03 (high-dose)
    Pharmaceutical form: liquid; route of administration: intramuscular injection
Experimental
Cohort 2: Group 9: SARS-CoV-2 vaccine HD + AS03 		Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
  • Biological: CoV2 preS dTM-AS03 (high-dose)
    Pharmaceutical form: liquid; route of administration: intramuscular injection
Experimental
Cohort 2: Group 10: SARS-CoV-2 vaccine HD 		Participants received a single IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
  • Biological: CoV2 preS dTM (high-dose) without adjuvant
    Pharmaceutical form: liquid; route of administration: intramuscular injection
Placebo Comparator
Cohort 2: Group 11: Placebo 		Participants received an IM injection of placebo matching to SARS-CoV2 on Day 1 and Day 22, respectively.
  • Biological: Placebo (0.9% normal saline)
    Pharmaceutical form: liquid; route of administration: intramuscular injection

Recruiting Locations

More Details

NCT ID
NCT04537208
Status
Completed
Sponsor
Sanofi Pasteur, a Sanofi Company

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.