Case study: Dorset resident supports COVID-19 vaccine research
A Dorset resident describes his experience of taking part in COVID-19 vaccine research.
A Dorset resident is supporting efforts to find multiple safe and effective vaccines for COVID-19, by taking part in a research.
Mel, a retired project manager, decided to volunteer for the trial of a COVID-19 vaccine developed by US-based biotechnology firm Novavax in October 2020.
Mel, who is married and has lived in Dorset for the last 30 years, first heard about the trial when a call for volunteers was made through a local exercise club.
“What surprised me was that they wanted 25 percent of volunteers to be between 65 and 85 years old,” Mel explained. “I fell into that category so I decided to put myself forward. Friends have asked me why and it’s quite simple really. If you don’t, there won’t be any medical advances. There are altruistic reasons as well, of course, because you’re helping.”
For Mel, taking part in the trial involved completing an online questionnaire and attending a screening appointment at the Dorset Research Hub, a new vaccine research facility within the Royal Bournemouth Hospital, which has been setup in response to the pandemic.
“When I arrived at the hospital, doctors and nurses carried out various checks, measuring things like my blood pressure, weight and BMI. It was like a mini MOT! The staff talked through what the trial involved and were keen to stress that I could drop out at any point during the trial if I wanted to. I was given the contact details for a 24 hour helpline which I could call if I needed support. It was all very reassuring and extremely efficient.”
As a double blind, placebo-controlled trial, participants were selected at random to either receive two doses of the Novavax vaccine or a placebo, which in this case was a saline injection. A process called blinding meant that neither the participants nor the research team knew what each participant had received, helping to ensure the results of the trial were not influenced by existing expectations.
Mel added: “My first appointment included the vaccination, but of course, you don't know whether you're getting the placebo or the Novavax vaccine. Three weeks later, I went back to have a second vaccination. I did get a few side effects which made me and my doctor think that I’d probably received the real vaccine rather than the placebo, and this was confirmed when I was later unblinded during the trial.”
When Mel was contacted by the NHS to receive the approved COVID-19 vaccine, an unblinding process was used to let him know whether he had received a placebo or the active trial vaccine. This process, available on every COVID-19 vaccine trial, ensures that all participants are protected through either approved or trial vaccines.
Mel explains: “In January, I got an invitation to have the approved vaccine through the NHS so I called the 24 hour research number to find out what I’d had. The doctor at the end of the phone confirmed that I’d received the Novavax vaccine and that I didn’t need to have an approved vaccine through the NHS. I was impressed with how efficient the process was.”
After vaccination, Novavax participants like Mel are monitored regularly to understand the longevity of the immune response and the degree of protection given.
Mel describes his experience of taking part in research as positive and is keen to promote the benefits of research to others.
“My experience of research has been very good. All the staff have been so considerate and kind, smiley and welcoming. I feel proud of everyone who has put effort into developing the vaccines. You can see how hard everybody has been working, it’s not just the doctors and nurses, it’s everyone behind the scenes too.”
Mel continues: “I would definitely recommend taking part in research. We all benefit from the knowledge gained through research.
“For example, as a result of my previous medical history, I take four different tablets a day, one of which is an ACE inhibitor. ACE inhibitors have been trialled by volunteers before me in the same way that the vaccines are now. In fact, the ACE inhibitor trial was cut short because the effects were so beneficial. I’m really grateful to everyone who took part in that trial.”
The NIHR-supported Novavax trial is the largest ever double blind, placebo-controlled trial to be undertaken in the UK. It recruited over 15,000 participants from 35 UK research sites in just over two months.
Alongside Mel, almost 600 other volunteers from Dorset took part in the trial, helping researchers in their search for multiple safe and effective vaccines that can tackle the pandemic.
In February 2021, interim analysis of the Novavax Phase 3 trial data showed that the vaccine is 89.3% effective at preventing COVID-19 and effective against the new variants of concern.
The interim efficacy and safety data was submitted to regulators across the world - including the Medicines & Healthcare products Regulatory Agency (MHRA) in the UK - for independent scrutiny and product approval.
The UK public can continue to support the national effort to speed up vaccine research and receive more information about volunteering for future COVID-19 vaccine studies by visiting the NHS COVID-19 Vaccine Research Registry and the Be Part of Research website.