COVID-19 Vaccine Study FAQs
Visit: COVID 19 Vaccine Study
No. We are only enrolling people who have never tested positive for COVID-19 to assess the effectiveness of the vaccine to prevent COVID-19 infection.
The information collected about you is for research purposes only. This information will not be used to guide your medical care.
The research study cannot provide medical care if you become sick. The questionnaires and at-home testing are for research purposes only.
If this research study involves the diagnosis or treatment of a medical condition, then Protected Health Information (PHI) collected from you during this study will be placed in your medical record, and may be used to help treat you, arrange payment for your care, or assist with Medical Center operations.
What happens if I test positive? Will I have to stay home for 2 weeks? What financial support do I have? If I’m antibody positive, does that mean I can’t be in the community?
We are working with the Maya Angelou Center for Health Equity and the Integrating Special Populations program at Wake Forest School of Medicine to engage with our diverse Winston-Salem community.
In addition, listed below are just a few of the amazing organizations we have partnered with to spread the word about the study:
- YMCA of NW North Carolina
- Love Out Loud
- Hispanic League
- The Twenty
- HUSTLE Winston-Salem
- Forsyth Tech Small Business Program
- Alpha Phi Alpha Fraternity, Inc.
- St. Peter’s World Outreach Center
- Second Harvest Food Bank NC
- Iglesia Sin Fronteras
- Alianza Cristiana y Misionera
- Forsyth County Department of Public Health
Why are you targeting certain populations to participate in this study and get the investigational COVID-19 vaccine?
As you are aware, the COVID-19 pandemic is a global public health emergency.
By studying who has been exposed and possibly infected, better identifying the timing and circumstances of exposure, and where infection patterns of the COVID-19 are advancing, researchers can help the medical community better understand the pandemic and develop strategies and treatments to contain and possibly eliminate it.
- Most phase 3 clinical trials have a large number of patients, at least several hundred.
- These studies are often done in many places across the country (or even around the world) at the same time.
- These studies tend to last longer than phase 1 and 2 studies.
- Placebos may be used in some phase III studies, but they’re never used alone if there’s a treatment available that works.
As with other studies, patients in phase III clinical trials are watched closely for side effects, and vaccination is stopped if they are too bad.
The Phase 2 study was designed to understand what dosage of the mRNA-1273 vaccine provides the best immune response with the least amount of harmful side effects. Phase 2 study also includes a group of people who receive a placebo (salt + water solution) to compare as a baseline to the groups that get different doses of the vaccines. Group 1 gets the placebo, Group 2 gets the vaccine at a 100mg dose and Group 3 gets a 250mg dose, 28 days apart. Participants are randomly selected to be in each group.
This Phase 3 study is expected to include approximately 30,000 participants at the 100 microgram (µg) dose level in the U.S. because it was found to be safe, produced an immune response, and had minimal severe side effects in humans.
Based on findings from Phase 1 and 2 studies of the mRNA-1273 vaccine, participants have reported experiencing fatigue (80%), chills (80%), headache (60%) and muscle pain (53%), all of which were transient and mild or moderate in severity. The most common solicited local adverse event at the 100 microgram (µg) dose was pain at the injection site (100%), which was also short-lived and mild or moderate in severity.
Like all medicines and vaccines, the study vaccine and the other ingredients in the formulation may cause side effects, although not everyone gets them. The most likely side effect you may have from the study vaccine are pain, redness, and swelling where the shot is given, headache, muscle pain, joint pain, fever, feeling tired, nausea/vomiting, underarm gland swelling on the side of the vaccination, and shivering. In addition to side effects from the study vaccine, you may feel faint or have mild pain, bruising, irritation, or redness where the blood samples are taken.