Clinical Trials / Research Studies
COVID-19 Investigational Vaccine Study for Adults 18 to 64 years old
Why are we doing this research?
Cincinnati Children's is conducting a research study, also known as a clinical study or trial, to learn if a new investigational COVID-19 vaccine is safe, and may prevent serious illness or keep the virus from spreading to others.
Who can participate?
Adults 18 to 64 years of age who are generally healthy or with stable chronic medical conditions and:
- Interested in participating in a COVID-19 vaccine study.
- Has been at least 4 months or longer since receiving last COVID-19 vaccine.
- Received a complete primary FDA-authorized or approved COVID-19 vaccine series and at least 1 booster.
- No positive COVID test in the past 4 months.
Conditions
- Healthy Adults
- Vaccines
What will happen in the study?
The study includes at least 8 planned study visits and one phone contact over 6 - 7 months. You may be requested to come into our study center for visits outside of your scheduled visits if you have any symptoms of COVID-19. Here are some of the things that will happen in this study:
- You will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.
- You will sign a consent form to show that you agree to be part of the study.
- You will be asked about your health and any medications you take.
- You will have a physical exam including blood pressure, temperature, heart rate, height, and weight.
- You will have blood and nasal samples collected.
- If female and can become pregnant, have a urine pregnancy test.
- Receive an intradermal injection (injection given just under the skin) in your upper arm.
- You will receive either a low dose, medium dose, or high dose of the study vaccine. It will be chosen randomly (like flipping a coin) and you will not know which dose you received until your final study visit.
- Complete a symptom diary for 8 days to record any symptoms that may occur after receiving the study vaccine.
What are the good things that can happen from this research?
You may or may not personally benefit from your participation in this trial. However, by taking part, you will help to provide new scientific information that will contribute to the development of COVID-19 vaccines.
What are the bad things that can happen from this research?
As with any vaccine, you may have side effects. Possible risks and discomforts will be discussed with you prior to the start of the study.
Will you/your child be paid to be in this research study?
Participants will receive up to $1,000 for time and effort to complete the study.
Contact
The Vaccine Research Center at Cincinnati Children’s
https://redcap.link/GyldenCovid
513-636-7699
VaccineResearch@cchmc.org
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229-3039
Study Doctor
Rebecca Brady MD
Infectious Diseases
Find More
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include any information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time. NCT07183709.
3333 Burnet Avenue, Cincinnati, Ohio 45229-3026
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