Study of Recombinant Protein Vaccine Formulations Against COVID-19 in Healthy Adults 18 Years of Age and Older
COVID-19 (Healthy Volunteers)
About this trial
This is an interventional prevention trial for COVID-19 (Healthy Volunteers)
Eligibility Criteria
Inclusion Criteria:
- Aged 18 years of age or older on the day of inclusion
- Informed consent form has been signed and dated
- Able to attend all scheduled visits and to comply with all study procedures
Exclusion Criteria:
- Participant is pregnant, or lactating, or of childbearing potential and not using 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 must be 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 may be received at least 2 weeks before and a minimum of 2 weeks after study vaccines
- Prior administration of a coronavirus vaccine (severe acute respiratory syndrome coronavirus 2 [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, is at a stage where it might interfere with study conduct or completion
- Receipt of any therapy known to have in-vitro antiviral activity against SARS-CoV-2 within 72 hours prior to the first blood draw
- Health care workers providing direct patient care for COVID-19 patients
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- Investigational Site Number 8400004
- Investigational Site Number 8400012
- Investigational Site Number 8400011
- Investigational Site Number 8400019
- Investigational Site Number 8400016
- Investigational Site Number 8400002
- Investigational Site Number 8400001
- Investigational Site Number 8400007
- Investigational Site Number 8400008
- Investigational Site Number 8400003
- Investigational Site Number 8400014
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Cohort 1: Group 1: SARS-CoV-2 vaccine LD + AF03
Cohort 1: Group 2: SARS-CoV-2 vaccine LD + AS03
Cohort 1: Group 3: SARS-CoV-2 vaccine HD + AF03
Cohort 1: Group 4: SARS-CoV-2 vaccine HD + AS03
Cohort 1: Group 5: Placebo
Cohort 2: Group 6: SARS-CoV-2 vaccine LD + AF03
Cohort 2: Group 7: SARS-CoV-2 vaccine LD + AS03
Cohort 2: Group 8: SARS-CoV-2 vaccine HD + AF03
Cohort 2: Group 9: SARS-CoV-2 vaccine HD + AS03
Cohort 2: Group 10: SARS-CoV-2 vaccine HD
Cohort 2: Group 11: Placebo
Participants received a single intramuscular (IM) injection of SARS-CoV2 vaccine low-dose (LD) formulation along with adjuvant AF03 on Day 1.
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
Participants received a single IM injection of SARS-CoV2 vaccine high-dose (HD) formulation along with adjuvant AF03 on Day 1.
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
Participants received an IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
Participants received an IM injection of placebo matching to SARS-CoV2 on Day 1 and Day 22, respectively.