Student Perspectives on Participating in a COVID-19 Vaccine Trial
We asked UMB students to share about their experiences about participating in a COVID-19 vaccine trial. We hope that sharing these stories will highlight the role that clinical trial participants played in the rapid development of safe, effective vaccines against COVID-19 and make the vaccine trial process more transparent for those who may wish to one day participate themselves.
Participants in COVID-19 Clinical Trials:
- David Rach, PhD Student, Microbiology and Immunology
- Michael Sikorski, MD-PhD Candidate
- Karndeep Singh, 2nd Year PhD Student, GPILS Biochemistry and Molecular Biology
What was your motivation for participating in a COVID-19 vaccine trial?:
David - Campus had been shut down for over a month, and every morning the news was about increasing cases, hospitals overwhelmed, and more deaths worldwide. As a Microbiology & Immunology PhD student, it was frustrating not being able to do anything about it beyond explaining Viruses 101 to family/friends on social media. So, I signed up as soon as I heard about the CVD trial.
Michael - As a young, healthy person as well as an MD-PhD candidate studying microbiology, epidemiology, and vaccinology, I felt that I could not only contribute to vaccine research but also help to communicate my experience to family and friends using my knowledge of vaccines and immunology.
Karndeep – I graduated from UMBC for my undergraduate degree and one of the leading scientists who developed the mRNA-based vaccine for COVID-19 – Dr. Kizzmekia Corbett – is also a fellow UMBC graduate. While I was working on my research during the quarantine period, I was inspired by Dr. Corbett’s call for participants from minority populations to participate in the clinical trial. I was terrified at the number of increasing cases and knew that if I had the opportunity to participate in the trial, it would be one step closer to developing an effective vaccine to help the world move forward from this pandemic.
How did you hear about the trial?
David – Near simultaneous list-serve emails sent to the Malaria Research Division and the Microbiology & Immunology Department.
Michael – I heard about the CVD’s Phase 1 Pfizer trial through our Departmental listserv. I called the CVD’s phone number, they screened my eligibility, and I was scheduled for an appointment the following week. I think I was the 4th or 5th person to join this trial.
Karndeep – Originally, I heard about the trial through my fellowship program. I am a part of the Meyerhoff Graduate Fellowship and our advisor shared that the Moderna COVID-19 clinical trial was looking for minority participants. I was one of the last participants offered a spot in Moderna’s clinical trial before UMB started their Novavax COVID-19 clinical trial.
What was the process like for your first appointment? Did anything surprise you?
David - After an initial phone eligibility screening, the in-person screenings in late April 2020 felt surreal. There were no cars on MLK boulevard; the grass was unmowed and a foot tall; and campus felt like a ghost town. But as soon as you stepped into HSF-I, the CVD clinical floor was a wall-to-wall of activity, with doctors, nurses and staff all in PPE making sure to get through the health screening, that all touched objects were sanitized, and that everything was ready to go the instant the go ahead was given. It was a very different dynamic compared to when I would walk by the floor a couple months before, and spoke to the importance and urgency of what the CVD was doing in getting the first Pfizer COVID-19 vaccine trial in the US up and running.
Michael - At our first appointment, the study doctors had to be sure we did not have any past exposures to COVID-19. Using a plastic cartridge lateral flow immunoassay similar in design to over-the-counter pregnancy tests, our blood was tested for antibodies against COVID-19. Mine showed a line next to the "negative" sign. This was especially interesting to observe because these tests had been manufactured only weeks prior and were truly at the forefront of point-of-care COVID-19 testing. I took a photograph of my April 2020 negative result and sighed with relief to know that I had not been exposed to COVID-19 previously.
Karndeep – To start the process, I filled out two screening application and then I received an initial phone call to determine my eligibility. My first in-person appointment was scheduled at 7 AM on a brisk October morning. This was my first time being at back at the UMB campus in six months. The beginning of my appointment involved watching an introductory video that covered all of the details of the trial followed by an in-person screening. After spending about an hour of handling paperwork, I had my blood withdrawn and I received a nasopharyngeal COVID-19 test. The test was very quick but very uncomfortable as the COVID-19 test I have taken were nasal swabs. Then I was given my vaccine and asked to wait for 30 minutes to ensure that I did not experience any adverse side effects upon immediately receiving the first dose, whether I received the real vaccine or the placebo.
If you have previously participated in a clinical trial before, what were some similarities and differences between your prior experience(s) and that of the COVID-19 vaccine trial?
David, Michael, and Karndeep – This was their first time participating in a clinical trial.
If this was your first clinical trial, did it go as you expected? Was anything surprising?
David – Yes.
Michael - Clinical trials and their participants usually do not garner much media attention unless the intervention is a wild success. When I volunteered for the trial in April 2020, I did not fully realize the magnitude of my participation in this Phase 1 clinical trial of a new mRNA-based COVID-19 vaccine candidate. When I accepted an invitation to share my experience with Fox45News Baltimore, I quickly was contacted for about a dozen interviews with a multitude of news agencies: The Baltimore Sun, The Washington Post, Voice of America, the Danish Broadcasting Corporation, and VEJA Brazil. It was a great opportunity for me to practice my science communication skills, and I was especially proud of the video interview with Voice of America because it was translated into languages around the world and I could share it with friends and family abroad.
Karndeep – I did not know what to expect as this was my first clinical trial, but it went very smoothly. The nurses, doctors, and administrators working on the clinical trials at UMB were all fantastic – the entire staff was willing to help out and ensure that I felt comfortable with moving forward in the clinical trial. One aspect of the trial that caught me by surprise was the side effects that I experienced after both of my doses. After receiving my first dose, I had arm pain and later on, I experienced chills where I was covered with a weighted blanket and still felt chilly. My second dose symptoms were worse, but I felt prepared – one aspect of my second dose symptoms that surprised me was I developed a fever and there was one point when I was unable to walk because of my body’s fatigue. Overall, the clinical trial was and still a smooth experience; however, the symptoms I experienced caught me by surprise.
If you have been unblinded from your trial, what was that process like? How did you feel about having the chance to be unblinded from the study and still be able to continue in the trial?
David - Uneventful. Based on my reaction to the second dose, I was fairly confident that I was in the vaccine group so receiving the email wasn't too shocking. I am glad to go forward knowing what I got and that the trial followups over two years will still go forward to get the data about antibody duration/response to booster dose. I was happy after the unblinding to be given the CDC vaccination card though, not traveling anywhere yet, but figure I will need it.
Michael - After the Pfizer vaccine received Emergency Use Authorization from the FDA in December 2020, our Phase 1 study was unblinded because it would not have been ethical to maintain a placebo group when the benefits of vaccination were sufficient for EUA. All placebo recipients received the Pfizer vaccine at that time. However, I actually thought I knew my study group about two months earlier! As a PhD student, I dutifully reviewed the interim data from our Phase 1 study published two months prior to EUA. I deduced that I was in the low-dose (10mcg) vaccine group of Pfizer's BNT162b1 based on my reported side effects and the lack of those side effects reported in the placebo group. In December, I found out that my conclusion was correct. I was asked to stay in the trial for continued safety measurements until 2 years post-vaccination, and I was eligible in February to receive a booster shot to measure the effects of booster shots on immune protection. Of course, that knowledge did not change my behavior then and it has not changed my behavior now- I continue to wear masks, socially distant, avoid large gatherings, and follow all CDC guidelines.
Karndeep – After the Moderna mRNA vaccine received emergency use authorization, the physicians leading the clinical trial informed us that we would have the opportunity to be unblinded from the study. If we were placed in the placebo group, we would have the opportunity to receive the vaccine. If we were placed in the treatment group, we would receive our official vaccination card and have the opportunity to continue to participate in the trial to further collect data about the long-term protection provided from the vaccine. I was excited to see my official results, but I had a hunch that I was placed in the treatment group as I experienced a fever after my second dose. This turned out to be correct, so I received my vaccination card and I continue to complete my electronic diaries, my phone check-ins, and my in-person meetings to ultimately help determine the long-term protection of the vaccine.
Anything else you would like to share regarding your experience participating in a COVID-19 vaccine trial? We would love to hear it!
David - In hindsight, the day of the first vaccinations one moment in particular stands out more than the vaccine itself. All the volunteers had naso-pharyngeal swabs taken early that morning, being rushed to the lab for PCR testing to make sure all the volunteers were still negative for SARS-COV-2 before the vaccines were given. As we waited for the lab and the mid-morning passed by there was suspense in the air for all involved. When the results came back negative, everyone (volunteers, CVD clinical staff) let out a collective sigh of relief, we were now clear to go get our randomized dose of vaccine or placebo.
Michael - I am affiliated with the Center for Vaccine Development (CVD) and the Institute for Genome Sciences (IGS) here at the University of Maryland School of Medicine. One year after the World Health Organization declared COVID-19 a global pandemic, I am still chipping way at my PhD from my rowhome in South Baltimore. Meanwhile, the CVD has rolled out Phase 1/2 and Phase 3 trials of three different vaccine candidates - Pfizer/BioNTech, Moderna, and Novavax. CVD faculty who taught me virology, immunology, and microbial pathogenesis also sit on state, federal, and international committees and working groups to advise on the safety, efficacy, and equitable distribution of COVID-19 vaccines. The IGS has sustained massive uninterrupted PCR testing operations for the State of Maryland and University System of Maryland since the start of the pandemic and has recently been tasked with sequencing at least 10% of SARS-CoV-2 strains isolated in Maryland to monitor for variants of concern. As I join what sometimes feels like endless Zoom meetings to learn from my faculty mentors and colleagues, I frequently take a moment to beam with pride at the contributions of this institution to our global pandemic response.
Karndeep – I feel surprised and shocked that it has been an entire year since the start of the COVID-19 pandemic. I started working in my PhD thesis research laboratory for two weeks where I was able to purify one protein before my PI informed me that I would need to start working from home for the next few months as most of the country was informed to quarantine and work from home. However, while most individuals could not have predicted that the pandemic would have this outcome, I am glad I had the opportunity to participate in the Moderna mRNA COVID-19 and I hope that the data that is collected from the participants can continue to guide our country’s response to the pandemic and ultimately help develop other mRNA-based vaccines.
Thanks David, Michael and Karndeep for sharing your stories!