Why I Enrolled into the Moderna COVID-19 Vaccine Trial

By C. Andrew Martin, DNP, MS, RN, CNE, ACRN, CHPN

I turned 66 years old on Thursday, March 12, 2020. Because of my age, I was considered to be one of the initial, at-risk populations for complications from COVID-19. Consequently, the next day, I decided to voluntarily stay at home. Eleven days later, Travis County Judge Sarah Eckhardt issued an order for residents to stay at home to help reduce the spread of coronavirus by reducing social interactions. I like to believe I was ahead of the curve with implementing COVID-19 preventative measures.

While spending more time at home during those late winter months, the burning question became: What will I do, and not do, under this self-imposed stay-at-home order with reduced social interactions, in addition to being considered an at-risk population? My work life would be relatively unchanged as an online graduate nursing professor who has been working from home for the past four years; however, my one clinical day per week working at a community-based organization interacting with HIV-infected individuals would now be modified to working remotely from home for an undetermined length of time.

With less social interaction opportunities outside the home, I began to ponder what more I could do, both as an individual and as a nurse, regarding the pandemic.

A Sense of Purpose

The answer unexpectedly arrived one morning in May; a Facebook post came across my desk from Benchmark Research, located within two miles from our Austin home, posting a call for COVID-19 vaccine trial volunteers. They were actively seeking senior volunteers as part of a 30,000-participant study that was being conducted in up to 100 study sites throughout the United States.

As a practicing AIDS Certified Registered Nurse, I have referred numerous HIV-infected clients to local HIV medication clinical trials over the past eight years. When discussing the risks and benefits of entering a trial, my clients’ deciding factor of the benefits was oftentimes both financial and altruistic: complimentary medications prescribed during the trial period and being in a study that gave them a sense of purpose.

This Facebook post now presented me with my COVID-19 stay-at-home sense of purpose: being an agent of change more so than participating in a study for financial or medication access reasons. A phone call to Benchmark Research resulted in a screening appointment on June 19th for the Moderna Phase 2a, Randomized, Observer-Blind, Placebo-Controlled, Dose Confirmation Study.

During the initial four-hour appointment, there was the signing of consents, a physical assessment, and blood draws. Their decision of my eligibility to participate would be shared within the week. When the call came, I was notified that I did not qualify for Phase 2a secondary to one lab result reporting not within normal limits. However, I was assured that I would qualify for Phase 3 and would be contacted at the time that phase opened later in the summer. I was devastated with this news.

The Study

The timeframe that I was awaiting a callback for Phase 3 allowed me an opportunity to delve more into the study parameters. Its goal was to learn about how the body would react to the study vaccine. I was able to research the mRNA component of the vaccine and understand how it is a genetic code that instructs cells to produce a spike protein, which is found on the surface of the virus that causes COVID-19, causing an immune response and the production of antibodies.

Because, one, the study vaccine did not contain weakened or killed SARS-CoV-2 virus, two, participants have been enrolled in Phase 1 since March and Phase 2 since May without reported serious side effects, and three, it was unknown if the mRNA study vaccine technology would be effective, I felt positive reinforcement for my commitment to participate in the Phase 3 trial.

The study was anticipated to take place over 25 months with minimal commitments: six scheduled in-person visits and periodic safety telephone calls, and these study requirements could easily be scheduled into my life for two years. There was also financial reimbursement for the in-person visits and safety phone calls. Financial motivation was not my reason for joining the study; however, if I were chosen to participate, I planned to spend the reimbursements on small self-indulgences as a personal recognition of trial participation.

The Injection

It was not until August that I received the phone call to be assessed for the Moderna Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study. During my second four-hour appointment at the research site, I once again signed new consents and had a physical assessment and blood draws; however, at this appointment I received the first of two injections, which would be spaced 28 days apart. A month later I returned for the follow-up injection. I was not informed if I received the vaccine or placebo.

During this latter stage of the ongoing clinical trials in Austin, I knew of others who were currently in either the ongoing Pfizer or Moderna trials and they had shared some of their minor side effects following the two injections: fever, muscle aches and fatigue, pain at the injection site, or no noticeable side effects. Because I experienced no reportable side effects following the first and second injections, I assumed, whether correctly or not, that I may have received the placebo and not the vaccine. This was one time that I actually wanted to experience minor side effects as a possible affirmation of receiving the vaccine and not the placebo.

Regardless of not knowing whether I received the vaccine or the saline placebo, I continued to selectively be out in the public during the past nine months; however, these outings have been limited compared to my pre-COVID world, and I have always been conscious of wearing face coverings and maintaining physical distancing. As of this writing, over the past nine months I have not contracted the coronavirus.

Just over three months following the second injection and following the recent filings for FDA Emergency Use Authorizations, Moderna notified study participants that it is their intention to ensure that all participants ultimately have the option of receiving the vaccine. Whether I received the coronavirus vaccine or the placebo, I believe that I made the right choice to enroll into this vaccine study; and I am proud to share that my participation in a clinical study contributes to providing scientific data that may benefit not only myself, but also millions of people in the near future.

The Update

My clinical employer announced on Dec. 28, 2020, that vaccines could be scheduled locally for designated health care providers. I immediately called Benchmark Research to notify them of this community vaccine opportunity. However, as of that date, they were not yet prepared to offer the vaccine to the study participants. My choice would be to either wait until offered by them and remain in the study or to be unblinded from the study and access the vaccine in the community.

I decided not to wait. I found out that I received the placebo last summer and was released from their study. I received my first Pfizer COVID-19 vaccine later that day and the second vaccine on Jan. 15, 2021. It was encouraging to think that I did not contract the virus during the study and, by receiving the vaccine in late December, I may have a longer immunity time.

If you are curious as to how I have spent study reimbursements received to date, you may find me with new Native sunglasses and various Keith Haring designer face coverings! Following my experience, I encourage study participation and vaccination!