I’m just on my way home after a visit to a UCLH research lab, having been injected earlier today with two doses of lab-grown COVID antibodies (two – one for each buttock). It’s been an extended visit: first, almost an hour with a doctor, explaining the study and asking screennin questions. Then followed a lateral flow test. When that came back negative, but not before, they were able to order the antibodies from the hospital pharmacy. With an expected hour delay waiting for it to arrive, I had time to get out for some lunch. After the injections, I was still not allowed to leave. I’m now being kept here a further hour under observation, to check for any adverse reaction.
This is for a sub-study of the PROVENT clinical trial I joined in January last year. The point of both studies, is to test the effectiveness of laboratory grown antibodies as a possible alternative to vaccines for people with compromised immune systems, or for whom vaccination may for any other reason not be suitable. Early in the vaccine development process, it was felt that it was not known to what extent COVID vaccines would be effective, so Astra Zeneca (and other companies) developed this alternative approach. To be clear, this was not because the vaccine would not be effective, but just that it was not known how effective it would be. Also, it was not clear if GIST patients really are more at risk than other groups (some GIST specialists believed it to be so, other disagreed). Either way, the combination of imatinib use and loss of spleen together with my stomach when I had my GIST taken out, qualified me in terms of government guidelines, so I was very happy to join the original trial last January.
That involved an initial visit and injections at the first visit, followed by several more physical monitoring visits to UCLH during the next twelve months, ad weekly telephone or email monitoring checks, culminating in what should have been the last one last month. However, at that visit they told me that the trial has been extended a further three months, so they want me back again in April. I thought that was that – but no. Two weeks ago, they wrote to me to say that AZ are now doing a sub-study, to check the value of a second dose on antibodies, and would I be happy to participate? Of course I said yes, and so here I am. (For the record, I know that in the initial trial I was given the antibodies, not the placebo. They told me that when I was unblinded, after being offered the standard vaccine. The terms of the sub-study are such that everybody who was on the antibodies first time, gets antibodies again).
That leaves me excessively well protected. I’ve now had two lots of antibodies, as well as three standard COVID vaccinations. In addition, the NHS wrote to me in December to warn that because I’m classed as extremely vulnerable, I should do a PCR test at the first sign of any symptoms – no matter how mild. To make that possible, they sent me in the post a PCR test kit (marked “priority” test kit) to keep always on hand. (After I did in fact use that test last month – which gave a negative result- they sent me a replacement). Finally – if all these protections fail and I somehow get COVID after all, as an extremely vulnerable person, I am guaranteed fast track access to new COVID treatments still in trial but not yet approved for general use. So, on paper I may be vulnerable – but I have abundant compensating protections. Looking ahead, iI will need to return for a further six monitoring visits over the next year, and will answere weekly email questions to check progress, If I do show or report any suspicious symptoms, they wiill send a nurse out to my home, for a thorough examination. (They did that last March, all the way from central London to the south of Surrey when there was something of concern in a blood test. AT 8:30 on a Saturday morning, I had a nurse at my door).
So, I’m fine. What does it mean for everyone else. especially for other GIST patients? Well, I think it’s extremely good news. While it’s still not entirely clear to me whether all GIST patients are necessarily more vulnerable to GIST, there will certainly be some who are – and there will be some people who for one reason or another are not suitable for vaccinations. For such people, the antibody approach could be a useful alternative strategy. Also, in parallel with the PROVENT trial I was one, there was a second trial with the same product, for use in cases where people who had not been vaccinated, believed they had been in contact with someone with COVID. In such cases, where it is too late for vaccination, direct injection of the antibodies could produce rapid protection. We still wait for the final results of both trials, but preliminary analysis done at the half way stage was extremely encouraging: for PROVENT (the arm I was on), there was found to be 83% risk reduction compared to the placebo group, no serious disease and no deaths.
It’s also worth noting that Astra Zeneca are not the only company testing this approach. On the BBC News at 10 last night, there was an item taken inside a hospital of a patient being treated with what was described as “monoclocal COVID antibodies” – exactly analagous to the product I’ve been given. It’s not the same though – that was being delivered by infusion, mine was done by injection. When I discussed this witht the doctor administering the trial this morning, he confirmed that other companies are indeed developing similar products.
Overall, this has to be considered a good news story – yet more weaponry in the fight against COVID, for all those who for any reason may be, or feel themselves to be, especially vulnerable.