Study of mRNA Vaccine Formulation Against COVID-19 in Healthy Adults 18 Years of Age and Older
The primary objectives of the study are: - To describe the safety profile of all participants in each age group and each study intervention group up to 12 months post-last dose. - To describe the neutralizing antibody profile at Day 1, Day 22, and Day 36 of each study intervention group. The secondary objectives of the study are: - To describe binding antibody profile from Day 1 to Day 387 of each study intervention group. - To describe the neutralizing antibody profile from Day 90 to Day 387 of each study intervention group. - To describe the occurrence of virologically-confirmed COVID-19-like illness and serologically-confirmed SARS-CoV-2 infection. - To evaluate the correlation/association between antibody responses to SARS-CoV-2 mRNA vaccine and the risk of virologically-confirmed COVID-19-like illness and/or serologically-confirmed SARS-CoV-2 infection.
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
: - Aged ≥ 18 years on the day of inclusion. - A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: - Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, or surgically sterile. OR - Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first vaccination until at least 12 weeks after the last vaccination. A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 8 hours before the study intervention. - Informed Consent Form has been signed and dated. - Participant not eligible to receive, based on local guidance, or if eligible does not intend to receive an authorized/approved COVID-19 vaccine from first vaccination until completion of the key timepoint of Day 43 of follow-up of this study.
- History of COVID-19 disease or prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed serologically. - 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). - 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. - Known liver disease or fatty liver. - Positive test for chronic active Hepatitis B surface antigen, Hepatitis B core antibody, Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody from blood work collected at screening visit. - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination based on Investigator's judgment. - Receipt of immuneglobulins, blood or blood-derived products in the past 3 months. - Prior administration of a coronavirus vaccine (SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome coronavirus [MERS-CoV]). - 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. - Receipt of any therapy known to have in-vitro antiviral activity against SARS-CoV-2 within 72 hours prior to the first blood draw or planned use of such therapy 72 hours prior to study immunogenicity blood draws at Day 22 and Day 36. - Residence in a nursing home or long-term care facility. - 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.
- Phase 1/Phase 2
- Study Type
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- This is a sequential group prevention study consisting of a sentinel cohort followed by the Full Enrollment Cohort. There will be 3 dose levels (up to 25 participants 18-49 years of age for each dose level) in the Sentinel Cohort, which will be done in an open-label fashion with stepwise safety evaluation for each dose level and each vaccination. All sentinel participants will receive 2 vaccinations, 21 days apart. For the Full Enrollment Cohort, participants will be stratified into 2 age groups based on age at enrollment: the younger adult age group (140 participants 18-49 years of age) and the older adult age group (168 participants ≥ 50 years of age). The Full Enrollment Cohort 1 (Groups 1 to 4) will receive a single injection of study intervention while participants in Cohort 2 (Groups 5 to 8) will receive 2 vaccinations (to be given 21 days apart).
- Primary Purpose
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- In the Full Enrollment Cohort: blinding for vaccine group assignment (formulation) of participants, outcome assessors, Investigators, laboratory personnel, and Sponsor study staff. Only study site staff who prepare and administer the vaccine and are not involved with the safety evaluations will be unblinded to vaccine group assignment. There will be no blinding for injection schedule. The Sentinel Cohort is open-label (no blinding).
|1 injection of SARS-CoV-2 mRNA vaccine formulation 1 at Day 1||
|1 injection of SARS-CoV-2 mRNA vaccine formulation 2 at Day 1||
|1 injection of SARS-CoV-2 mRNA vaccine formulation 3 at Day 1||
|1 injection of placebo at Day 1||
|2 injections of SARS-CoV-2 mRNA vaccine formulation 1 at Day 1 and Day 22||
|2 injections of SARS-CoV-2 mRNA vaccine formulation 2 at Day 1 and Day 22||
|2 injections of SARS-CoV-2 mRNA vaccine formulation 3 at Day 1 and Day 22||
|2 injections of placebo at Day 1 and Day 22||
Rolling Hills Estates, California 90274
Hollywood, Florida 33024
Miami, Florida 33122
Iowa City, Iowa 52242
Kansas City, Missouri 64114
Rochester, New York 14609
Philadelphia, Pennsylvania 19104
North Charleston, South Carolina 29405
Houston, Texas 77081
Salt Lake City, Utah 84107
- NCT ID
- Sanofi Pasteur, a Sanofi Company
Study ContactTrial Transparency email recommended (Toll free number for US & Canada)
The duration of each participant's participation in the study will be approximately 365 days post-last injection: approximately 386 days duration for participants receiving 2 injections and approximately 365 days duration total for participants receiving a single injection.