By: Amelia Gibson, PhD, MBA, Senior Director of Product Licensing at Kerafast and Absolute Antibody
It’s rare that one gets to participate in something as historic and globally impactful as the development of a COVID-19 vaccine. While I know little about vaccine development and no longer do any benchwork, I knew that I could contribute in a small, but meaningful, way by participating in a clinical trial. I had been following along with the rest of the world as well-known pharmaceutical companies and prominent research institutions around the world announced breakthroughs in the development of treatments and vaccine candidates to COVID-19. When I learned there was a need for volunteers to participate in the Phase III clinical trial for the vaccine developed and produced by Oxford University and AstraZeneca, I immediately contacted the local research firm managing the trial. This would be my first time participating in a clinical trial, and I had no idea what to expect.
After completing an online questionnaire, I was contacted by a study coordinator to answer further questions about my medical history and to ensure there was a reasonable chance I could be exposed to COVID-19. It was determined I would be a suitable candidate to participate in the study, and I was informed the study would last for 24 months with multiple in-person and virtual obligations. The first visit took nearly two hours, with form after form requiring signature, health screening, blood collection, and a nasal swab. The nurse working with me was then able to randomize whether I would receive the experimental vaccine or the placebo and provided that information to the pharmacist. The study is double-blinded, so only the pharmacist knows what I received. The injection was quick and painless. I waited 15 minutes to ensure I did not have an allergic reaction and was sent home with instructions on symptoms to report immediately.
My appointment was finished at 9:30am, and by 2pm, I had not experienced any symptoms, not even soreness in my arm. I felt admittedly disappointed that I had possibly received the placebo. As a scientist, I understand the importance of including a placebo in a study and the value in having that data, but I wanted the experimental vaccine for my own curiosity. By 4:30pm, things changed. I started to feel chills, body aches, and I developed a slight fever. I was ecstatic! I decided to go to bed early to sleep through the symptoms but woke in the middle of the night feeling too hot to fall back asleep. My temperature had reached 102.6oF, and I finally decided to take some ibuprofen. By the morning, I felt mostly back to normal, with some soreness in my arm but no other notable side effects.
My second visit was short with some additional forms to sign, blood collection, and the second injection. I was pleasantly surprised to find that I did not experience any side effects this time. I have since returned once for blood collection, and I have been completing an e-diary weekly. I will continue these activities until the end of the study. Though a minor contribution to the overall process of developing, approving, and distributing a vaccine, I’m glad I was able to play a small part.
Amelia has been part of the Kerafast team for more than seven years, working with scientists and technology transfer offices at research institutions worldwide to facilitate access to unique reagents by licensing the materials for addition to our online catalog. Several reagents in the catalog have also played a role in advancing COVID-19 research, including the Delta-G-VSV pseudotyping system, recombinant coronavirus antibodies, and SARS-CoV-2 expression plasmids. Most recently, Kerafast was recognized by BioNTech for support in developing their COVID-19 vaccine, as we provided antibodies and plasmids used in their vaccine research and development.