COVID-19 Vaccine Study FAQs
Visit: COVID 19 Vaccine Study
Call: 336-713-7888
Email: covid19vaccinestudy@wakehealth.edu
The purpose of this study is to test an experimental study vaccine that may protect people from a viral infection called the coronavirus disease (also called, “COVID-19”) caused by the 2019 novel coronavirus (the virus is also called, “SARS-CoV-2”). There is currently no vaccine to protect people from SARS- CoV-2 infection. The mRNA-1273 study vaccine is intended to boost the immune system to produce enough antibodies against SARS-CoV-2; so, in case of an exposure, the virus does not cause illness.
The study length is 25 months and includes 6 visits to the clinic and 25 phone calls. In addition, if you are diagnosed with COVID-19, you will have 2 additional clinic or home visits and daily telemedicine visits by videoconference or telephone for 14 days after illness visit or until your symptoms have resolved, whichever is longer. If you choose to participate in this study, you will receive 2 injections of study vaccine or placebo given about 1 month apart.
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.
COVID-19 is a highly contagious virus that is spread by respiratory droplets. Being in the study does not increase your chances of getting the virus. During study visits or if you become sick, you will be asked to provide nasopharyngeal swabs. Nasopharyngeal swab is a method for collecting a test sample of nasal secretions from the back of the nose and throat to test for COVID-19.
Anyone who is aged 18 years and older can participate in the study.
For your participation in this study, you will receive compensation for your time per completed in-office visit and for each completed safety call and diary submission.
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.
There is still a lot we do not know about COVID-19. We certainly understand your concerns about a positive antibody test. We encourage you to talk to your primary care physician about the test results and/or call our study call center: 336-713-7888
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
We are working with the Maya Angelou Center for Health Equity at Wake Forest Baptist Health and other community-based organizations to engage African Americans about COVID-19, vaccines, and this study. We cannot guarantee a certain percentage of representation from Hispanic and/or Black/African American participants; however, we are making concerted efforts to ensure they have access to the study and are encouraged to participate.
Given the increased morbidity and mortality of COVID-19 in older and elderly adults, additional evidence for the potential of a vaccine to protect this population is an urgent priority. It is important for racial/ethnic minorities and members of vulnerable populations to participate to understand how it affects African Americans and better develop prevention options that are appropriate for underserved communities.
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.
Call 336-713-7888 to arrange transportation to and from the study site.
No. You do not need to be a patient of Wake Forest Baptist Health to participate in the study.
- 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.
There are multiple vaccine trials happening right now. We are examining multiple vaccines because one could work better than the other or could get to market faster, depending on its response in humans and the number of people participating in the study. As scientists learn more from the vaccine trials, they will share lessons learned in publications that will be available for the public.
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.