Phase 2
N=441
Study of Recombinant Protein Vaccine Formulations Against COVID-19 in Healthy Adults 18 Years of Age and Older
COVID-19 (Healthy Volunteers)
Bottom Line
View on ClinicalTrials.gov: NCT04537208 ↗Enrolled (actual)
441
Serious AEs
1.8%
Results posted
Jun 2023
Primary outcome: Primary: Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 1 — 5.00; 5.00; 5.00; 5.00 titers
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CoV2 preS dTM-AF03 (low-dose) (Biological); CoV2 preS dTM-AF03 (high-dose) (Biological); CoV2 preS dTM-AS03 (low-dose) (Biological); CoV2 preS dTM-AS03 (high-dose) (Biological); CoV2 preS dTM (high-dose) without adjuvant (Biological); Placebo (0.9% normal saline) (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 1 |
5.00; 5.00; 5.00; 5.00; 5.00; 5.00 | — |
| PRIMARY Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 22 |
5.00; 5.00; 5.00; 5.27; 5.00; 5.00 | — |
| PRIMARY Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 36 |
5.00; 5.00; 5.00; 5.31; 5.17; 11.5 | — |
| PRIMARY Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22 |
1.00; 1.00; 1.00; 1.05; 1.00; 1.00 | — |
| PRIMARY Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36 |
1.00; 1.00; 1.00; 1.06; 1.03; 2.42 | — |
| PRIMARY Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22 |
0; 0; 0; 1; 0; 0 | — |
| PRIMARY Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36 |
0; 0; 0; 1; 1; 7 | — |
| PRIMARY Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22 |
0; 0; 0; 4.2; 0; 0 | — |
| PRIMARY Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36 |
0; 0; 0; 4.2; 4.2; 43.8 | — |
| PRIMARY Number of Participants With Immediate Unsolicited Adverse Events (AEs) |
0; 0; 1; 0; 0; 0 | — |
| PRIMARY Number of Participants With Solicited Injection Site Reactions |
18; 30; 21; 28; 5; 19 | — |
| PRIMARY Number of Participants With Solicited Systemic Reactions |
0; 0; 0; 0; 0; 4 | — |
| PRIMARY Number of Participants With Unsolicited Adverse Events |
10; 9; 9; 10; 8; 13 | — |
| PRIMARY Number of Participants With Medically Attended Adverse Events (MAAE) |
5; 3; 4; 5; 4; 8 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAE) |
2; 1; 1; 0; 0; 1 | — |
| PRIMARY Number of Participants With Adverse Events of Special Interest (AESIs) |
0; 1; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance |
0; 0; 0; 1; 2; 1 | — |
| SECONDARY Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387 |
9.45; 9.80; 9.45; 10.1; 9.45; 11.7 | — |
| SECONDARY Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387 |
3.67; 6.30; 4.88; 15.8; 1.00; 3.67 | — |
| SECONDARY Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387 |
14; 17; 15; 21; 0; 10 | — |
| SECONDARY Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387 |
6.89; 8.81; 5.00; 9.99; 10.9; 31.7 | — |
| SECONDARY Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387 |
1.38; 1.76; 1.00; 2.00; 2.19; 6.34 | — |
| SECONDARY Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387 |
2; 2; 0; 2; 4; 1 | — |
| SECONDARY Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387 |
13.3; 14.3; 0; 13.3; 25.0; 25.0 | — |
| SECONDARY Number of Participants With Virologically-confirmed Coronavirus Disease (COVID-19)-Like Illness |
— | — |
| SECONDARY Number of Participants With Serologically-confirmed SARS-CoV-2 Infection |
— | — |
| SECONDARY Correlates of Risk / Protection Based on Antibody Responses to SARS-CoV-2 |
— | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04537208). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.