Study of Recombinant Protein Vaccine Formulations Against COVID-19 in Healthy Adults 18 Years of Age and Older
NCT ID: NCT04537208
Last Updated: 2025-09-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
441 participants
INTERVENTIONAL
2020-09-03
2021-11-19
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
PREVENTION
QUADRUPLE
Study Groups
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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.
CoV2 preS dTM-AF03 (low-dose)
Pharmaceutical form: liquid; route of administration: intramuscular injection
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.
CoV2 preS dTM-AS03 (low-dose)
Pharmaceutical form: liquid; route of administration: intramuscular injection
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.
CoV2 preS dTM-AF03 (high-dose)
Pharmaceutical form: liquid; route of administration: intramuscular injection
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.
CoV2 preS dTM-AS03 (high-dose)
Pharmaceutical form: liquid; route of administration: intramuscular injection
Cohort 1: Group 5: Placebo
Participants received an IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
Placebo (0.9% normal saline)
Pharmaceutical form: liquid; route of administration: intramuscular injection
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.
CoV2 preS dTM-AF03 (low-dose)
Pharmaceutical form: liquid; route of administration: intramuscular injection
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.
CoV2 preS dTM-AS03 (low-dose)
Pharmaceutical form: liquid; route of administration: intramuscular injection
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.
CoV2 preS dTM-AF03 (high-dose)
Pharmaceutical form: liquid; route of administration: intramuscular injection
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.
CoV2 preS dTM-AS03 (high-dose)
Pharmaceutical form: liquid; route of administration: intramuscular injection
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.
CoV2 preS dTM (high-dose) without adjuvant
Pharmaceutical form: liquid; route of administration: intramuscular injection
Cohort 2: Group 11: Placebo
Participants received an IM injection of placebo matching to SARS-CoV2 on Day 1 and Day 22, respectively.
Placebo (0.9% normal saline)
Pharmaceutical form: liquid; route of administration: intramuscular injection
Interventions
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CoV2 preS dTM-AF03 (low-dose)
Pharmaceutical form: liquid; route of administration: intramuscular injection
CoV2 preS dTM-AF03 (high-dose)
Pharmaceutical form: liquid; route of administration: intramuscular injection
CoV2 preS dTM-AS03 (low-dose)
Pharmaceutical form: liquid; route of administration: intramuscular injection
CoV2 preS dTM-AS03 (high-dose)
Pharmaceutical form: liquid; route of administration: intramuscular injection
CoV2 preS dTM (high-dose) without adjuvant
Pharmaceutical form: liquid; route of administration: intramuscular injection
Placebo (0.9% normal saline)
Pharmaceutical form: liquid; route of administration: intramuscular injection
Eligibility Criteria
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Inclusion Criteria
* Informed consent form had been signed and dated.
* Able to attend all scheduled visits and complied with all study procedures.
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi Pasteur, a Sanofi Company
Locations
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Investigational Site Number 8400004
Birmingham, Alabama, United States
Investigational Site Number 8400012
Rolling Hills Estates, California, United States
Investigational Site Number 8400011
Hollywood, Florida, United States
Investigational Site Number 8400019
Melbourne, Florida, United States
Investigational Site Number 8400016
Boston, Massachusetts, United States
Investigational Site Number 8400002
Omaha, Nebraska, United States
Investigational Site Number 8400001
Rochester, New York, United States
Investigational Site Number 8400007
Rochester, New York, United States
Investigational Site Number 8400008
Cleveland, Ohio, United States
Investigational Site Number 8400003
Philadelphia, Pennsylvania, United States
Investigational Site Number 8400014
Mt. Pleasant, South Carolina, United States
Countries
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References
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De Rosa SC, Cohen KW, Bonaparte M, Fu B, Garg S, Gerard C, Goepfert PA, Huang Y, Larocque D, McElrath MJ, Morris D, Van der Most R, de Bruyn G, Pagnon A. Whole-blood cytokine secretion assay as a high-throughput alternative for assessing the cell-mediated immunity profile after two doses of an adjuvanted SARS-CoV-2 recombinant protein vaccine candidate. Clin Transl Immunology. 2022 Jan 11;11(1):e1360. doi: 10.1002/cti2.1360. eCollection 2022.
Goepfert PA, Fu B, Chabanon AL, Bonaparte MI, Davis MG, Essink BJ, Frank I, Haney O, Janosczyk H, Keefer MC, Koutsoukos M, Kimmel MA, Masotti R, Savarino SJ, Schuerman L, Schwartz H, Sher LD, Smith J, Tavares-Da-Silva F, Gurunathan S, DiazGranados CA, de Bruyn G. Safety and immunogenicity of SARS-CoV-2 recombinant protein vaccine formulations in healthy adults: interim results of a randomised, placebo-controlled, phase 1-2, dose-ranging study. Lancet Infect Dis. 2021 Sep;21(9):1257-1270. doi: 10.1016/S1473-3099(21)00147-X. Epub 2021 Apr 19.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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VAT00001 Plain Language Results Summary
Other Identifiers
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U1111-1250-4757
Identifier Type: OTHER
Identifier Source: secondary_id
VAT00001
Identifier Type: -
Identifier Source: org_study_id
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