CLEVELAND (WJW) — After releasing promising results from their Phase I clinical trial for a COVID-19 vaccine (as seen in the video above), biotech company Moderna is ready to begin Phase III on July 27 and is looking for some 30,000 volunteers for the trial.
Cleveland is one of the many cities where researchers are looking for volunteers. Moderna says they have finished manufacturing the vaccine required for the next trial. This phase will help prove if the shots really are strong enough to protect against the coronavirus.
The company is looking for people who are at high risk of contracting the virus due to their location or circumstances. Participants must be 18 years of age or older.
Speaking of the demographics in Phase I with a group of 45 people, Dr. Dan Culver, a pulmonologist at the Cleveland Clinic and Chair of the Therapeutics Assessment Committee, says he hopes more populations are represented in the study.
“It’s important to remember that this trial was conducted in a younger, healthier population,” he said. “Fifty-five was the maximum age, there were very few African American patients in this trial and they didn’t have chronic health conditions and, of course, we know that those are the sorts of populations that are likely to have more serious complications from COVID.”
Below is a list of the full 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.
More information can be found here.
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