SARS-CoV-2 study: MRNA-1273 vs MRNA-1283
Official title A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Formulations
ClinicalTrials.gov ID: NCT07863635
What this study is testing
What is mRNA-1273?
An investigational injectable vaccine being studied for protection against SARS‑CoV‑2. It is designed to stimulate the immune system to recognize the virus’s spike protein.
Also referred to as Spikevax.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how well the new mRNA‑1283 and mRNA‑1273 variant vaccines trigger an immune response and how safe they are in the current COVID‑19 environment.
- What's involved
- Participants will receive the mRNA‑1283 and mRNA‑1273 variant vaccines and may have blood tests and follow‑up visits to monitor safety and immune response.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older. Healthy volunteers may be eligible.
You may be able to join if
- ≥65 years of age at the time of signing the informed consent OR ≥12 to \<65 years of age at the time of signing the informed consent with at least 1...
- Female participants of childbearing potential may be enrolled in the study if not pregnant or breastfeeding, subject to other criteria specified in...
You likely can't join if
- History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 3 months prior to enrollment.
- Acutely ill or febrile within 72 hours prior to or at Day 1.
- History of a diagnosis or conditions that in the Investigator's opinion could affect participant's safety, assessment of endpoints, assessment of...
- Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections.
- History of coagulopathy or bleeding disorder that is considered a contraindication to IM injection or phlebotomy.
- COVID-19 vaccine within 3 months prior to enrollment,
See the full eligibility criteria
- ≥65 years of age at the time of signing the informed consent OR ≥12 to \<65 years of age at the time of signing the informed consent with at least 1 risk factor for severe outcomes from COVID-19.
- Female participants of childbearing potential may be enrolled in the study if not pregnant or breastfeeding, subject to other criteria specified in the study protocol.
- History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 3 months prior to enrollment.
- Acutely ill or febrile within 72 hours prior to or at Day 1.
- History of a diagnosis or conditions that in the Investigator's opinion could affect participant's safety, assessment of endpoints, assessment of immune response, or adherence to study procedures.
- Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections.
- History of coagulopathy or bleeding disorder that is considered a contraindication to IM injection or phlebotomy.
- COVID-19 vaccine within 3 months prior to enrollment,
- Any licensed non COVID-19 vaccine within 28 days before or planned receipt within 28 days after the study intervention, except an influenza vaccine, which may be given 14 days before or after receipt of the study...
- Systemic immunosuppressive treatment within 180 days prior to the Screening or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study,
- Systemic immunoglobulins, long-acting biological therapies that affect immune responses, or blood products within 90 days prior to the Day 1 Visit or plans for receipt during the study.
The study team makes the final eligibility decision.
Where it is enrolling
- Overland Park, Kansas, United States
- Louisville, Kentucky, United States
- Charlotte, North Carolina, United States
- Hendersonville, Tennessee, United States
- Prosper, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Overland Park, Kansas, United States; Louisville, Kentucky, United States; Charlotte, North Carolina, United States; Hendersonville, Tennessee, United States; Prosper, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.