CLEVELAND (WJW) – After releasing promising results from its Phase I clinical trial for a COVID-19 vaccine (as seen in the video above), the biotechnology company Moderna is ready to begin Phase III on July 27, looking for approximately 30,000 volunteers for the experiment.
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 helps to prove if the shoots are really strong enough to protect against 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 1
Given the demographics in phase I with a group of 45 people, says Dr. Dan Culver, a pulmonologist at the Cleveland Clinic and chairman of the Therapeutics Assessment Committee, said he hopes more populations are represented in the study.
“It is important to remember that this experiment 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 did not have chronic health conditions, and of course we know that these are the types of populations that are likely to have more serious complications. From COVID.”
Below is a list of all the criteria for inclusion:
- Participants at high risk for SARS-CoV-2 infection, defined as adults whose sites or circumstances present a significant risk of exposure to SARS-CoV-2 and COVID-19.
- Understands and agrees to follow the study procedures and gives written informed consent.
- Be able to follow study procedures based on the assessment of the investigator.
- Female participants with non-fertile children can participate in the study. Non-fertile fertility is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥ 12 consecutive months before screening without alternative medical cause). A follicle-stimulating hormone level (FSH) can be measured at the investigator’s discretion to confirm postmenopausal status.
- Female participants of childbearing potential may participate in the study if the participant meets all of the following criteria:
- Have a negative pregnancy test at screening and the day of the first dose (day 1).
- Have practiced adequate contraception or have given up all activities that may lead to pregnancy for at least 28 days before the first dose (day 1).
- Have agreed to continue adequate contraception for 3 months after the second dose on day 29.
- Currently not breastfeeding.
- Male participants participating in activities that may lead to pregnancy in sexual partners must agree to practice adequate contraception and refrain from sperm donation from the time of the first dose until 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 a disease that does not require a significant change in therapy or hospitalization to worsen the disease during the three months prior to enrollment.
More information can be found here.
Interested participants can contact Rapid Medical Research Inc. or Modern Clinical Trials at 855-663-6762 or 216-508-4400. You can also email [email protected]
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