The Other Side of Clinical Research: My Experience in the J&J COVID Vaccine Trial (By Julia Chiemi)

In EMRA, we obviously get the amazing privilege of taking part in the clinical side of groundbreaking research in the ED which is one of my favorite things about our program. However, students in lab research know the oft-cited feeling of “a disconnect” from the work they are doing; one of the downsides of research in general is that it’s not an “instant gratification” discipline. The application of the intervention you’re studying may be years down the line from the research itself, and it’s sometimes hard to fully appreciate your part in the research process when your goal is so abstract and intangible in the present. Though working on clinical research through EMRA gave me a little bit more involvement in the research process and helped me appreciate it even more, it wasn’t until I became a research participant myself that I gained a full and new perspective on the groundbreaking work we get to be a part of.

Last fall, COVID rates were high, hospitals were overwhelmed, and no vaccines had been rolled out yet. I had started working in a clinical setting at the beginning of summer, and even though we did our fair share of double masking, sanitizing and changing PPE between patients, and regular temperature checks between our small team at the practice, I couldn’t help but feel nervous going into work knowing that I went home each day to my entire family (including my grandma who lived with us at the time). In late October, I decided to enroll in a Phase 3 vaccine trial run by Janssen pharmaceuticals; the product of which would later be released as the Johnson & Johnson adenovirus COVID vaccine.

My study appointment was in early November; it was a four-hour visit to their clinic, but I was actually super interested the whole time in observing the workflow and its similarities (and differences) from the EMRA clinical research process in the Reagan ED. The entire visit was highly organized, with the first two hours dedicated to going through a massive consent/Bill of Rights packet that had at least 25 signatures peppered throughout it. I could tell that J&J was extremely thorough in designing their protocol. And thankfully, the clinical research staff at the clinic was amazingly professional and well-trained in their workflow, and took the time to explain everything about the experimental vaccine and study process to me as a prospective patient. Not that I had reservations about receiving the vaccine in the first place; to me, the potential risks of an experimental shot were vastly outweighed by the chance of getting an active agent and protecting my family. But it was still reassuring to get to hear directly from the study staff exactly what went into the vaccine they developed, what I could expect in terms of symptoms and efficacy, and how the study was being conducted (double-blind, placebo-controlled, international). I signed everything, got a copy of my signed consent packet and Bill of Rights to take home, and finally the clinical portion of the visit could begin.

The most unpleasant part was first: a nasal swab in the open-air parking lot tent. After a negative test was confirmed, I was allowed back inside the clinic and brought to the phlebotomy lab, where they took about 5 ccs of blood to do a baseline antibody test. I also had a brief physical exam. All of those steps would later be repeated at my subsequent study visits, with the most important being the blood draw. As part of the study, we were actually barred from receiving external antibody tests (as this would interfere with the blinding if we tested positive for antibodies and then believed we’d received the vaccine). I thought this was interesting given that many workplaces were requiring antibody tests for employees at the time, but it made sense given the study goals and design. Also important to note: this was not a paid study. We were compensated via gift cards for our time spent completing the visits (which was a nice perk of being stuck there for hours during my visits), but participation itself was not paid.

Finally, after sitting in a waiting room for a good thirty minutes while they anonymized me and randomized me for the injection, I was brought back in to a patient room and watched them take my syringe out of the freezer to thaw. More waiting ensued. Even though I knew how important the blind aspect of the study was, I couldn’t help but be curious and stare at the thawing syringe on the counter to try and ascertain whether it was filled with saline or vaccine (unshockingly, they look the same and I couldn’t tell). Then before I knew it, the nurse’s timer went off, the needle went into my delt, I got a bandaid slapped on, and was shuttled off to another waiting room to sit for 15 minutes to ensure no adverse side effects. I’m convinced that clinic was actually just an endless tunnel of waiting rooms. When my time was up, I was given a bag with a study-approved thermometer and pulse-ox for at-home vital checks (which would be filled out on the study app every week), and went home with a very sore arm. I felt totally normal until about 6 PM that night, when a fever hit me like a ton of bricks. I don’t get sick often, but when I do it is absolutely brutal. The symptoms were typical of a severe cold/generalized immune response: chills, fever, vomiting, shakes. They lasted through the night, unfortunately. In short, I was miserable for about 12 hours, slept it off, and in the morning I was fine except for a sore arm that lasted another 2 days. The fact that I’d had such strong symptoms (although no blood clots!!) was enough to cast pretty strong doubt on the idea that I’d gotten the placebo, but I wouldn’t find that out for sure until a few months later.

My study visits continued monthly as normal until January of 2021. At that point, the Pfizer and Moderna vaccines had been approved and rolled out to frontline workers by then, and my facility (Hoag) was giving Pfizer vaccines to clinical staff. In late January, J&J released their clinical trial results and submitted their one-shot vaccine for approval. Literally days after the J&J vaccine got approved, I got a call from the trial clinic asking me to come in for unblinding and to sign a new consent form. At this visit, they were going to tell us what injection we had received and then administer the J&J vaccine (if desired) to patients who had gotten the placebo. I thought this was super interesting; very rarely do we hear of clinical trials unblinding so soon after the start of the trial, but these were obviously insane circumstances. I went in for my visit later that week where they told me that I had in fact received the active vaccine. I signed the new consent form and was given the opportunity to ask the study physician questions. I had one: Am I now allowed to receive another COVID vaccine?

I felt weird asking this to the J&J doc, but I did so for a few reasons. Reason 1) the efficacy rate of the J&J vaccine was good (especially for a one-dose shot!) but it was lower than the other two available vaccines. I would have felt comfortable with this if it wasn’t for Reason 2) the Hoag building I worked at was not at all short on Pfizer vaccines. In fact, they told us that they were throwing perfectly good doses away, which concerned me. I decided that, given the fact that there was no reason NOT to, the possibility of added protection from getting another vaccine would help me feel even safer. Why not add some extra antibodies into the mix? The study doctor said yes, if I wanted to, I could go ahead and do as I wished since the trial had concluded its Phase III and they had gotten the data they needed from me. So I went and got two doses of the Pfizer vaccine through work. It did make me feel even safer in the end, but that doesn’t erase how grateful I am to have felt protected and comfortable going into work from November to January because of the study vaccine I’d gotten from J&J.

In the end, I gained a few things from this experience. #1: antibodies. #2: the opportunity to experience clinical research from a different lens. I took away a better understanding of the patient’s side of the research process, and left with a huge appreciation for the care and thought that goes into informed consent, transparency, and communication between the researcher and patient. It’s easy to say “We should be compassionate, thorough, and understanding when we interact with patients in the ED for our research!”, but being the anxious patient on the other side of the interaction helped me truly understand the difference that our actions as research associates can make. And finally, #3: I had the incredible opportunity to participate in something bigger than myself. When the study results were announced in the press, I think I had a crazy moment where I realized “I was a part of that.” Even if I had gotten the placebo (which, thankfully, I did not), I would still get to say that I was a part of bringing a lifesaving vaccine to completion in a time when it was needed, and that is something I would absolutely do again even with that one hellacious night of vomiting. All in all, this was an experience I am so grateful to have had, and I will absolutely be participating in more clinical research in the future when given the chance.