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Volunteering for a monoclonal antibody COVID19 clinical trial

Some of us with blood cancer have significantly impaired immune systems. Recently I was given a test vaccine dose to see how well the small numbers of B cells I have in my blood would respond to it. The answer: they didn’t even stir. Not even a hint of antibody formation. This didn’t surprise me and is another step towards me eventually probably going onto IVIG, which is antibody replacement.

It also means that for me at least I will probably not respond well to the COVID Vaccine. Some blood cancer patients will respond just fine. Since there is no clear way of predicting who will do well and who won’t, several doctors seem to be agreeing that it makes sense for someone to have an antibody test a few weeks after their COVID Vaccine to check it really has worked.

It could be dangerous to just assume the vaccine has worked, although is probably worth all of us having since it will work for some.

I am personally exploring another option.

This experimental treatment might provide protection not dependent on your own immune system

On Boxing Day (a peculiar UK invention that happens after Christmas Day) the UK newspapers were full of a story from UCLH about two studies of a monoclonal antibody cocktail aimed at preventing COVID19.

Both studies look at the same mix of two antibodies cloned after being obtained from convalescent plasma. The experimental treatment is injected into muscle and the hope is that the antibodies will gradually be released into the blood over approximately the following year, hopefully offering protection to the patient that is not dependent on their own immune system. This is a form of passive vaccination and is in many way similar to IVIG, although more purified (being man made), longer lasting and specific only to COVID19. The studies were described as follows:

Researchers in the STORM CHASER study led by UCLH virologist Dr Catherine Houlihan recruited the first participant in the world to the study earlier this month and have recruited 10 participants to date.

They believe the antibody or LAAB, known as AZD7442 and developed by AstraZeneca, may offer immediate and long-term protection to people who have been recently exposed to the SARS-CoV-2 virus, to prevent them developing Covid-19.

Dr Houlihan, also of UCL Infection & Immunity, said: “We know that this antibody combination can neutralise the virus, so we hope to find that giving this treatment via injection can lead to immediate protection against the development of Covid-19 in people who have been exposed – when it would be too late to offer a vaccine.”

The other study, PROVENT, is looking at use of AZD7442 in people who may not respond to vaccination (for instance where someone has a compromised immune system) or are at increased risk of Covid-19 infection due to factors such as age and existing conditions. UCLH infectious diseases consultant Dr Nicky Longley is leading the UCLH portion of PROVENT.

Dr Longley said: “We will be recruiting people who are older or in long-term care, and who have conditions such as cancer and HIV which may affect the ability of their immune system to respond to a vaccine. We want to reassure anyone for whom a vaccine may not work that we can offer an alternative which is just as protective.”

Read the rest: https://www.uclh.nhs.uk/news/uclh-doses-first-patient-world-covid-19-antibody-trial

It must be stressed that this is of course still an experimental treatment, although there is clearly a lot of emerging evidence that antibodies are important in fighting COVID19. So there is a reasonable hope that recipients of this treatment like this will most likely experience at least some degree of protection from the COVID19 virus which is not dependent on their own immune system.

There are two other short-acting monoclonal antibody treatments.

  • The Lilly treatment when tested in outpatients who already had COVID19 showed a 99% reduction in viral load.
  • The Regeneron antibody cocktail has also shown efficacy in patients with COVID19 who have not been able to mount an antibody response and has been given an FDA emergency use authorisation. This treatment can be hard to get even in the USA and I am not sure if it is available on a compassionate use basis anywhere else.
  • The Regeneron study enrolled patients who had both made or not made an antibody response of their own. While patients who had not made antibodies (which sadly some blood cancer patients would not be able to do) made up less than half of the trial population, they accounted for approximately two-thirds of the deaths in the group given placebo. This statistic alone makes clear the potential benefit of antibodies for patients who are known not to be able to produce them.
  • The Regeneron antibody cocktail is available in the USA under an emergency use authorisation. Your doctor should be able to apply for usage and funding via your insurance company if you are unlikely to make antibodies to COVID19. The sooner after infection you can get this the better. The doctor to apply would usually your blood cancer specialist if you are an outpatient or your hospital doctor if you have been admitted.
  • For use outside of the terms of the emergency use authorisation there is a compassionate use program which IS also available outside of the USA. Your doctor can email CompassionateUse_Requests@regeneron.com for more information on how to apply to the company This email was available publicly on the Regeneron website. Please do not email this address yourself, it must be your doctor that applies on your behalf. Blood Cancer specialists could contact this address ahead of time to understand how they would go about requesting this medicine for any appropriate patients who get COVID19.

Whilst many of us have been making huge efforts to protect ourselves from this virus, we cannot 100% guarantee that we will never be exposed.

Even if you are living alone or with a fellow “shielder” and not receiving visitors or going out except to walk outside, you cannot guarantee that you won’t need a hospital admission at some point in the next few months or some other emergency which would require you to mix with others. COVID19 will be with us for at least a number of months.

This is a randomised controlled trial and patients have a 1 in 3 chance of being injected with placebo or a 2 in 3 chance of having the active treatment. You will not be told which you receive.

The study that is most likely to be of interest to readers of this website is the second preventative study. A FAQ answered one of my crucial questions:

If someone takes part in the STORM CHASER and PROVENT trials, can they also have an approved vaccine when it is rolled out?
As licensed vaccines become available to qualifying trial participants, a mechanism will be put in place to enable them to safely leave the study if deemed medically beneficial. Being a trial participant in one of the studies will not delay the process of receiving a vaccination and should not prevent patients being involved in other studies if they do develop an illness related to Covid-19.

https://www.uclh.nhs.uk/news/uclh-doses-first-patient-world-covid-19-antibody-trial

There is a from you can register your interest in potentially participating in the passive vaccination study by completing this form. They will put you into contact with the site closest to where you live. The form works in the UK and USA.


UPDATE. A couple of people have had issues wirh the website. If you find it doesn’t work for you (if you get told there’s no site near you for example) please email uclh.provent@nhs.net and ask to be put in touch with a local site.

31 December Today I had a conversation with a friendly doctor from one of the investigational sites. They confirmed that if I entered the study and then offered a vaccine I would leave the study, and a similar process would happen if I do eventually get approved for IVIG.

The study visits are every four weeks and will include blood tests to check the antibodies are persistent in your blood. They are obviously very interested in whether people who are on the antibody ever develop COVID19, and if they do whether the level of severity is less than you might predict given their general health.

The doctor was able to confirm that blood cancer patients during a watch and wait or remission phase are definitely in their target population. Clearly if taking active chemotherapy at the time that would not be suitable, though in principle some patients on long term stable treatments such as Ibrutinib might be considered. Patients taking IVIG currently are also excluded, although if this treatment would be approved in the future one assumes that topping up IVIG with COVID antibodies would be a likely strategy to consider, although one hopes IVIG may eventually include sufficient donated COVID antibodies.

So, I am currently awaiting the full patient information leaflet which will include lists of any side effects experienced so far. The site I spoke to had slots in the first week of the New Year. So with a bit of luck, and assuming I am happy with the patient information, in a few days I may have a chance of receiving some immunity against COVID19. I will not of course know if I received the antibody or placebo, so this will not mean the end of shielding for me!

Update January 8th 2021

The deed is done. My butt cheeks have done their bit for science! No more pain than a blood test. In fact I’ve had blood tests hurt a LOT more than that did. It felt pretty easy really. So now there is a ⅔ chance that I have a years worth of slow release Covid antibodies inside me. Great feeling As whilst I’m not going to stop shielding at least it feels like I’ve done something already.

They are changing the protocol so it will be absolutely fine for me to have the vaccine when offered it but at the moment if you want to volunteer for this study you have to do it before vaccination. I guess what I did today might possible save me from getting very sick if I can’t avoid coming in contact with this disease.

The only thing is it does take quite a long time. Several hours in a clinic. BUT I checked with them before hand and there was no waiting room time needed. So I had a room wirh a window open I was masked and they were wearing full PPE. And I was only really in the same room as one doctor for any lenth of time and I could feel the breeze of lovely fresh air so felt very safe.

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Adrian Warnock
  • Adrian Warnock
  • Dr. Adrian Warnock is a medical doctor and clinical research expert who was himself diagnosed with blood cancer in May 2017. Adrian worked in the pharmaceutical industry for fifteen years helping to run the clinical trials that bring us new medicines and communicate the results. Before this he practised in the UK’s National Health Service (NHS), as a psychiatrist, for eight years.

    Adrian is a published author, the founder of Blood Cancer Uncensored, and has written a Christian blog since 2003 at Patheos. He is passionate about learning how to approach suffering with hope and compassion. Adrian's articles are not medical advice and he is not a haematologist or blood cancer doctor. Always seek individualised advice from your health care professionals. You can e-mail Adrian here.