So it’s come to my attention that there are some folks very interested in the current Crohn’s vaccine trial happening in Oxford and, being a trial participant, I might be able to shed some light what is going on. I’ll do my best to give you what information that I can and not compromise anything without knowing it. So let’s start with some basic info about me-
I’m a white American (now also British!) male, 41 years old. 100kg and 187cm – okay you probably didn’t need to know all that, but hey I feel I’m on display so why not give that info for those wondering.
As for my background, I am a PhD researcher currently working at the University of Oxford with the very group [Clinical Biomanufacturing Facility] who has physically made this vaccine that I recently got injected with [though when I signed up to do this trial, I didn’t know they had made the vaccine]. Prior to working with these folks, my research focus was on vaccines and rare diseases with focus on gene therapy of a few different types. But none of my research has been with Crohn’s or those associated with Crohn’s.
I do not have the disease (obviously) but my brother does. I have always kept him informed of the latest research and tried my best to translate it for him at a non-scientist level. And I made promise to him if I could ever help with the research in the disease in some way or another I would. So as soon as I found out about this study I got myself signed up and purposely requested to be one of the folks at the highest dosage level. I figured if I could tolerate it, he’d have a great chance too.
So what goes on as a volunteer for the vaccine? This is a lot simpler than most people think. You initially go through a quick screening process that does a quick health check [blood pressure, temperature, weight, height] and a blood draw. They also contacted my GP to make sure I had no medical history [i.e. bleeding disorders, etc] that would exclude me. They also had to check on my previous vaccines and any other trials I had participated in, in the past. I have participated in multiple vaccine trials in the past [if you work in vaccines, you have to support other folks however you can] so we had to make sure that I had not been vaccinated with the same type of adenovirus in the past, or at least not within the last 6 months. They felt that if at least 6 months had passed, it should not affect the vaccine even if the same base adenovirus was being used. Now there was one extra step I had to go through because I work within the Jenner institute, I had to go through and extra interview to prove no conflicts of interest. And before I fully enrolled I was also given a document explaining everything that was going to happen during this trial, the virus used, why the trial was taking place and how my info & biological materials were to be used.
Because this is a phase I trial for safety/tolerance the wait between this initial check and when I was finally vaccinated was much longer than normal, almost 3 months. I asked about this and they said it was because of the trial design.
No special prep was need to be vaccinated. On the day of vaccination I had my blood pressure and temperature checked, along with a new blood draw. I then went out to the waiting room while they prepped the vaccine. I was then called back and injected intramuscularly [they were also kind enough to ask which arm I preferred- I chose my non-dominant arm]. I then went back to the waiting room for a 1 hour waiting period to make sure I had no sudden immune response to the vaccine. They did two checks during that time. One check at 30 minutes, looked at the vaccine site and checked my temperature. Then at the 1 hour mark they checked my blood pressure along with the temp and injection site. I was given a card that had emergency info on it if I felt extremely ill and told what to do in case of serious side effects (i.e. how to deal with hospitals and when to call them). I was also given an electronic diary that I had write in each night. I had to return 24 hours later, then at 72 hours, 7 days, and 14 days. I still have to return at 28 days, 56 days, then 365 days. I find these time points interesting as I’m used to having a 3 month and/or 6 month check, not a 2 month check. But every trial is different and there are reasons behind this.
As for the scheduled visits, it is a simple process. With the exception of day 14, blood was drawn at each visit, along with a temperature check, and blood pressure. The injection site was inspected and measured for redness during the first 7 days. And we went over my diary entries. Most visits take less than 15 minutes.
I have been informed that I will have blood drawn again at day 28 and day 56 and I suspect at 1 year.
As for me, I’m not your everyday volunteer. I have been through 5 previous vaccine trials over the last 16 years [Small Pox, Anthrax, Bird Flu, Malaria, & RSV]. Plus my passion is vaccines, hence why I work with them. That said though, I’m still cautious. I make sure I understand the type of study I’m going into. I’m not normally willing to go into a study where there is a true risk to myself or my family [the exception was of small pox back in 2001; technically I could have infected others, including my wife, due to the nature of that vaccine]. And any study I do, I always ask would I be fine with my wife or friends participating in it. If not, then I wouldn’t participate. This was the first time I was willing to take a risk with a truly unknown vaccine as it was for my brother and a potential cure/relief for his Crohn’s. And then I also discovered my co-workers made the vaccine, so I knew who I could pick on if I got really sick.
I hope this, umm, ‘short’ bit of info has helped some folks, but I should state that I only know what any volunteer would know. Meaning I’m not privy to any info about how the vaccine is going in anyone else or what they are specifically looking for in the blood [obviously antibodies, but what levels and types, no clue].