A Study Looking at the Efficacy, Immune Response, and Safety of a COVID-19 Vaccine in Adults at Risk for SARS-CoV-2
- for people ages 18 years and up (full criteria)
- Healthy Volunteers
- healthy people welcome
- at UC Davis
- study startedestimated completion
This is a study to evaluate the effectiveness, immune response, and safety of a coronavirus disease 2019 (COVID-19) vaccine called SARS-CoV-2 rS with Matrix-M1 adjuvant in adults 18 years of age and older in the United States and Mexico. A vaccine causes the body to have an immune response that may help prevent the infection or reduce the severity of symptoms. An adjuvant is something that can make a vaccine work better. This study will look at the protective effect, body's immune response, and safety of SARS-CoV-2 rS with Matrix-M1 adjuvant in the study population. Participants in the study will randomly be assigned to receive SARS-CoV-2 rS with Matrix-M1 adjuvant or placebo. Each participant in the study will receive a total of 2 intramuscular injections over the course of the study. Up to 30,000 participants will take part in the study.
A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M1™ Adjuvant in Adult Participants ≥ 18 Years
SARS-CoV Infection Covid19 Coronavirus Coronavirus Infections Severe Acute Respiratory Syndrome SARS-CoV-2 rS/Matrix-M1 Adjuvant
You can join if…
Open to people ages 18 years and up
- Adults ≥ 18 years of age at screening who, by virtue of age, race, ethnicity or life circumstances, are considered at substantial risk of exposure to and infection with SARS-CoV-2.
- Willing and able to give informed consent prior to study enrollment and to comply with study procedures.
- Participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through 3 months after the last vaccination OR agree to consistently use a medically acceptable method of contraception from at least 28 days prior to enrollment and through 3 months after the last vaccination.
- Is medically stable, as determined by the investigator (based on review of health status, vital signs [to include body temperature], medical history, and targeted physical examination [to include body weight]). Vital signs must be within medically acceptable ranges prior to the first vaccination.
- Agree to not participate in any other SARS-CoV-2 prevention trial during the study follow-up.
You CAN'T join if...
- Unstable acute or chronic illness. Criteria for unstable medical conditions include:
- Substantive changes in chronic prescribed medication (change in class or significant change in dose) in the past 2 months.
- Currently undergoing workup of undiagnosed illness that could lead to diagnosis of a new condition.
- Participation in research involving an investigational product (drug/biologic/device) within 45 days prior to first study vaccination.
- History of a previous laboratory-confirmed diagnosis of SARS-CoV-2 infection or COVID-19.
- Received influenza vaccination or any other adult vaccine within 4 days prior to or within 7 days after either study vaccination.
- Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy.
- Chronic administration (defined as > 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to first study vaccination.
- Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to first study vaccination.
- Active cancer (malignancy) on therapy within 1 year prior to first study vaccination (with the exception of malignancy cured via excision, at the discretion of the investigator).
- Any known allergies to products contained in the investigational product.
- Participants who are breastfeeding, pregnant or who plan to become pregnant within 3 months following last study vaccination.
- Any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the trial vaccine or interpretation of study results.
- Study team member or first-degree relative of any study team member (inclusive of Sponsor, and study site personnel involved in the study).
- Current participation in any other COVID-19 prevention clinical trial.
- University of California Davis Medical Center
Sacramento California 95817-2201 United States
- National Research Institute
Los Angeles California 90057 United States
- Woodland Clinic Medical Group
Woodland California 95695 United States
- not yet accepting patients
- Start Date
- Completion Date
- Phase 3
- Study Type
- Last Updated