Taking part in a Covid-19 vaccine trial

As part of our community response, we’ve been collecting stories of personal experiences from the pandemic. So far, these have covered what it’s like to have the virus, and some commentary on different responses to the pandemic in other countries from Stroud residents who were abroad or have connections to other countries. We’re delighted to host below a different type of personal story from Gill Dickinson – about participating in a Covid-19 vaccine trial. At the end of this piece there is some information and links to updates on the trial, and how you can get involved in similar trials if you wish.

“The other day, I bumped into a friend I’d not seen for a while in the supermarket.

We chatted briefly and she asked if I’d had my first vaccination yet. When I told her I didn’t know, because I was participating in a vaccine trial and hadn’t yet learned whether I was receiving the live dose or the placebo, she told me how grateful she was for people like me.

Now, my friend is a nurse, and to be honest, I thought the boot was on the other foot, and that I should be thanking her. But she reminded me that it was people like me, who were willing to take part in trials, who made it possible for people like her to receive the fully licensed versions. Her comments made me reflect on my journey.

It was only back in January when I spotted a plea on one of my Facebook groups for new people to sign up to the latest Janssen trial, Ensemble 2, and decided that I’d apply. Why? I suppose I just felt it was the right thing to do. I was already signed up to the Nailsworth town council register of volunteers, and had been a ‘Good Sam’ responder for the Royal Voluntary Service since early on in the pandemic. Volunteering for a vaccine trial seemed just one more way of helping tackle Covid-19 in a practical way.

So it was that that a few weeks later, I found myself at Bristol’s Southmead Hospital for my first appointment. Before I could receive my first injection, the trial team took a detailed medical history, ran various tests, took blood samples and weighed me. They checked my blood pressure and
temperature, listened to my heart, prodded my ankles, and used one of those new-fangled pulse oximeters on me. They are small but clever!
Everything was very thorough, and the various trial team members I met were all cheerful, friendly and reassuring as they went about their tasks.
Once the medical tests were completed, each participant was given a ‘swag bag’ of items including an explanatory guide to the trial and what was expected of us, a thermometer, a pulse oximeter, a couple of Covid-19 swab test kits and some paperwork to be completed.

Almost 90 minutes after first being welcomed to the centre, I was seated in front a large projector screen with a checklist setting out how to access and complete the weekly diary entries we’d need to complete. I thought this would require us to answer lots of questions each week, but it turned out
we’d only have to answer one question, twice a week, and as long as the answer was ‘no, I’m not experiencing any Covid-like symptoms’, that’s all that would be required.

It was only then that I was ushered into a side room for the first of my two injections. I truly didn’t feel a thing. After a period of observation, and a check to make sure I wasn’t experiencing any adverse reactions, I was sent on my way. And I’m pleased to say that I didn’t experience any side-effects over the days that followed. In the meantime, I became eligible for one of the NHS vaccinations. If I’d had the real thing as part of the trial, then I wouldn’t need to take up this offer. But what if I was only receiving the placebo? I didn’t want to miss out! After a conversation with the medic overseeing my involvement, we decided that as my second trial jab was only a couple of weeks away, I’d wait. Once I’d attended that
second appointment, the team could then request that I be unblinded – and if it turned out I was ‘team placebo’, I could immediately book an appointment to receive one of the NHS ‘varieties’.

At the end of March, I attended my second appointment. This time, I did feel the injection and had an arm ache that lasted a couple of days. A small price to pay, I thought. Within 48 hours, I received the news from my trial doctor to say that the unblinding I’d requested had taken place and –
fantastic news! – I had indeed been receiving the live vaccine! I was delighted to learn that not only had I received a live dose that would help protect me, but also, I would not need two more injections, and that the NHS would be able to use my dose for someone else instead.

Now we’re into April, and it’s looking as though we will be able to slowly ease our way out of lockdown. Millions of people here in the UK have been vaccinated in an astonishing programme, which will help us protect ourselves and each another. With other vaccines also in the pipeline, we’re heading towards a world that will be better equipped to deal with the pandemic; a good reason for hope.

There are thousands of people like me who have taken part in trial around the world for several different vaccines. This gives me sense of pride – it’s because of these combined efforts that we already have brilliant vaccines that are effective and are protecting people against Covid-19.

My role isn’t over: there will be other visits, this time to Cheltenham Hospital for blood tests and so on, which will all be added to the bank of knowledge and data that will help the trial team track how each of us is doing for the months and years to come. It’s good to know my usefulness will continue for some time yet!”

Information on the Janssen trial – and other Covid-19 vaccine trials

Gill was one of more than 6,000 volunteers in the UK who took part in Phase 3 trials for the company’s 2-dose system. These are ongoing worldwide, including in the UK at 16 National Institute for Health Research (NIHR) sites across the country. Janssen Pharmaceutical Companies have a page on their website outlining the steps in the process around this vaccine so far.

The Janssen/Johnson & Johnson vaccine has been approved in the US in February and the EU in March, but – along with 4 other vaccines that the UK has provisionally ordered doses of, has not yet been approved here. Approved vaccines in the UK are the Pfizer/Biontech, Astra Zeneca/Oxford, and Moderna – this Sky News piece covers where clinical trials and approvals are for UK vaccines, and how many doses of each brand have been ordered.

30 million doses of Janssen’s vaccine have been pre-ordered by the government in summer 2020, with deliveries expected to arrive in the second half of 2021 – if the vaccine is approved for use by the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA reviews and analyses data to see if vaccines meets strict standards of safety and effectiveness.

Earlier this year, on 29th January 2021, the UK government reported that Janssen had “published positive data from the phase 3 studies of its single-dose COVID-19 vaccine candidate, showing it to be 66% effective overall in preventing coronavirus in participants. The data did not report any significant safety concerns relating to the vaccine, with no serious adverse events in vaccine recipients.”

The Gloucestershire Hospitals NHS Foundation Trust site is recruiting adults in Gloucestershire who have received their first dose of an approved COVID-19 vaccine to a study, ComFluCOV, which is looking at the safety andimmune response ofgiving the COVID-19 vaccines at the same time as the recommended seasonal influenza (flu) vaccines.

You can learn more about COVID-19 vaccine trials and “sign up to be contacted about taking part in approved UK coronavirus vaccine studies and other research” via the NHS wesbite – this means you’ll be joining the COVID-19 vaccine registry.