Monday, February 8, 2021

My Journey as a Clinical Trial Participant

    The COVID 19 pandemic has been trying for the entire planet and especially so for those working on the front line caring for those in the hospital. They worry that their patients may not live until the end of their shift. They talk to family members, sometimes with reports of their loved ones improving, too often to deliver the worst news. They’ve watched colleagues succumb to this disease, and sometimes have mourned the loss of their own. I have watched this with the luxury of being slightly off-sides. I work in a private practice, only having to occasionally round in the hospital. I see the stress and anxiety of my colleagues, worrying about their patients, their colleagues, whether there is enough PPE to keep them safe. My heart aches for them and I longed for a way to help make a difference for them, for those who survived this disease but will live with long term complications and those we have lost to it. Then, the opportunity to make a difference presented itself to me. I had the opportunity to enroll in a clinical trial for one of the COVID Vaccine candidates.

I live in New Jersey. I got my masters degree from Rutgers University. I used to do infections disease rounds in Robert Wood Johnson University Hospital, attached to Rutgers. And once again, I am a Rutgers student in their Doctor of Nursing Practice Program. When the university announced that they were seeking volunteers to participate in a clinical trial for the Janssen (Johnson & Johnson) vaccine, I jumped at the chance. All I needed to do was to fit it into my work/school schedule.

    I responded to an email sent out by the university and answered preliminary questions that the study team wound evaluate to determine if I were an appropriate candidate to participate in the trial at the end of October. On November 12, I was informed that I was approved for inclusion in the trial and I made my first appointment with the study team for December 3.

    The study team emailed me a copy of the informed consent form ahead of time to review. It was 35 pages long and very detailed. The email did state that a member of the trial team would be reviewing the whole form with me at my appointment. The trial participants would be followed for two years after receiving their injection. As with any randomized double blind placebo controlled study, neither I, nor the people at the trial site would know if I were getting a real vaccine or a placebo. With other vaccines on the verge of receiving emergency use authorization, I was well aware that by enrolling in the trial there was a very real chance that I wound not be eligible to receive another vaccine while participating in this trial, and again there was a 50/50 chance that I would get a placebo. Still, I was very excited to be a part of this process.

    On December 3rd, I pulled into the Robert Wood Johnson Hospital parking lot and made my way into the atrium. I was quite familiar with the building having done infectious disease rounds there for a couple of years. It was almost like coming home. I made my way to the research center and met a lovely nurse named Fey. We bonded over Star Trek (I as wearing my Starfleet medical insignia mask). She went over all the details of the consent form with me. She paid special attention to the part that talked about the one serious adverse event that had been documented with the vaccine in trail arm in Europe and made sure I was ok with continuing to proceed. I was, of course, still on board. We went over my complete medical history and current medications.

    Then I went into another room and my vital signs were checked, a Covid nasal swab was done and blood drawn. Next a nice young man came in and helped me download register on the trial participant app that I would use to track any symptoms I may have while participating in the trial.

Finally, I went to another room, sat in a recliner and another nurse gave me my shot. I barely felt a thing. I was told to wait there for the next 15 minutes for observation before I went on my way.

    A week later the Pfizer vaccine was approved for Emergency Use Authorization. Front line health care providers were first on the list. Since I occasionally do hospital rounds for vascular patients, I was on that list. BUUUUTTTT, I’m in a trial. What a conundrum! Well, I had decided to wait. I joined a Facebook group for people participating in various clinical trials. The question had come up and some frontline health care workers participating in trials for other vaccines reported that they had been unblinded so that they could get a vaccine and be protected, since they had the received a placebo in their trial. At my follow up visit I will ask what the study coordinators for my trial have in mind for us. I could of course drop out of the trial, but I’m hoping to avoid that as I entered the trial not to get a vaccine, but to contribute to the science. We’ll see what happens in a couple of weeks….

Lori Boyle, MSN, APN, CWS, WCC
Lori has been in nursing for more than 20 years. While in graduate school, she became aware of how many people were misunderstanding the science of vaccination and falling for misinformation. Since that time she has made it her mission to help people understand that the value and safety of vaccination as recommended, far outweighs the risks. In addition to Nurses Who Vaccinate she is also a member of Voices for Vaccines and the NJ Immunization Network.