CLEVELAND — Cleveland is among dozens of cities where researchers need volunteers to participate in a Phase III clinical trial to evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent COVID-19, according to ClinicalTrials.gov.
The lead sponsor of the study, ModernaTX, Inc. announced it needs 30,000 participants from various cities, including Cleveland and Cincinnati.
A Phase III trial is the final phase in a vaccine's development before it is approved and licensed, during which the vaccine is given to thousands of people and tested for efficacy and safety, according to the CDC.
The study is scheduled to begin on July 27, with an estimated completion date on October 27, 2022.
Anyone 18 and up is eligible to participate in the study. Other criteria includes:
Inclusion Criteria:
- Participants who are at high risk of SARS-CoV-2 infection, defined as adults whose locations or circumstances put them at appreciable risk of exposure to SARS-CoV-2 and COVID-19.
- Understands and agrees to comply with the study procedures and provides written informed consent.
- Able to comply with study procedures based on the assessment of the Investigator.
- Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥12 consecutive months prior to Screening without an alternative medical cause). A follicle-stimulating hormone (FSH) level may be measured at the discretion of the Investigator to confirm postmenopausal status.
- Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria:
- Has a negative pregnancy test at Screening and on the day of the first dose (Day 1).
- Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose (Day 1).
- Has agreed to continue adequate contraception through 3 months following the second dose on Day 29.
- Is not currently breastfeeding.
- Male participants engaging in activity that could result in pregnancy of sexual partners must agree to practice adequate contraception and refrain from sperm donation from the time of the first dose and through 3 months after the second dose.
- Healthy adults or adults with pre-existing medical conditions who are in stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.
Rapid Medical Research is the only local place participating in the Moderna study. It says it will be actively recruiting 300 people from Northeast Ohio.
"You could really be part of a life-saving, world saving vaccination,” said Jade Svoboda, the recruitment manager at Rapid Medical Research.
Each participant will meet with a team of doctors seven times over 25 months, according to Svoboda. The Beachwood based company does compensate its clients.
To get in touch with Rapid Medical Research call 216-508-4400 or head to their website.
To find more information about this study, including exclusion criteria, click here.
If you are interested in participating in the study, contact Moderna Clinical Trials at 855-663-6762 or at clinicaltrials@modernatx.com.
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