Alan Lodge's Blog

I am registered for the mixed vaccine trials, to try and find out with other enrolling participants who have received the first dose of either the Oxford-AstraZeneca, or Pfizer vaccine, to then be randomly allocated to receive either the same vaccine for their second dose, or a dose of the COVID-19 vaccines produced by Moderna or Novavax. The aim of this study is to determine whether combinations of safe and effective vaccine doses can be used flexibly and support the current vaccine rollout.

COVID-19 Vaccine Research Registry Newsletter April 2021

Dear Alan Lodge

Welcome to the NHS COVID-19 Vaccine Research Registry April newsletter from the Vaccine Taskforce. In this month’s issue, you will discover news of the latest vaccine studies to launch in the UK and how studies are offering crossover appointments to ensure all study participants now receive an active vaccine dose. We hope you find it helpful and interesting. Professor Andrew Ustianowski, National Clinical Lead for the UK NIHR COVID Vaccine Research ProgrammeSince you read our last COVID-19 Vaccine Research Registry newsletter, there have been a number of new vaccine study launches and key updates to studies currently running across the UK. As we have seen through the national vaccine rollout, it is clear that we need a number of different approved vaccine options to ensure we can carry on protecting the country against coronavirus.Earlier this month, Moderna became the third coronavirus vaccine to be rolled out in the UK, following the Pfizer-BioNTech and Oxford-AstraZeneca jabs. While the number of those vaccinated continues to grow and more COVID-19 deaths are prevented, and as lockdown restrictions begin to ease, clinical research into several more vaccine candidates remains a key focus at the National Institute for Health Research (NIHR) and the local Clinical Research Networks which deliver these important studies.For those who have received both doses of their COVID-19 vaccines, there will still be opportunities to join studies in the near future. Vaccine studies investigating booster vaccines and third doses are currently in set-up stages within the NIHR, and will help us gain a better understanding of possible future COVID-19 vaccine schedules. We will update on the progress of these studies through this newsletter. Your interest and engagement in these studies when they are ready to recruit will play a key role.If you are one of those who have received their first dose of your COVID-19 vaccine, and are awaiting your second dose, you can still help play an important part in vaccine research. One of the most recent COVID-19 vaccine studies to launch, Com-Cov2, is enrolling participants who have received the first dose of either the Oxford-AstraZeneca, or Pfizer vaccine, to then be randomly allocated to receive either the same vaccine for their second dose, or a dose of the COVID-19 vaccines produced by Moderna or Novavax. The aim of this study is to determine whether combinations of safe and effective vaccine doses can be used flexibly and support the current vaccine rollout. Please respond to your study email invitation if it arrives in your inbox.Below you can find out more about the latest vaccine studies to be launched within the UK and what makes these trials unique and key to our defence against the virus. As more people receive their vaccinations, some studies have needed to tweak their protocols to ensure research participants aren’t disadvantaged and are offered the same level of protection as to those receiving approved vaccines. This “crossover” process allows study volunteers to receive a licensed vaccine through the study they are enrolled on, without being unblinded. This allows researchers to gain the best possible data from each study to help identify more effective vaccines. More information on crossover appointments and unblinding can be found at the bottom of this newsletter and on the Latest vaccine news page on the Be Part of Research website. As ever, both your involvement and interest in COVID-19 research is greatly appreciated, and paramount to helping researchers discover further effective vaccines and treatments. Valneva Phase 1/2 Study Shows Early Positive Results The Valneva Phase 1/2 clinical trial has reported positive data for their COVID-19 vaccine candidate, VLA2001, with no safety concerns identified. It is the only study examining a whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe.Supported by NIHR, 153 healthy adults were recruited across four sites in Birmingham, Bristol, Newcastle and Southampton. Subject to Medicines and Healthcare products Regulatory Agency (MHRA) regulatory approval, Valneva plans to progress expeditiously into Phase 3 clinical development. Further details of volunteer enrolment will follow soon, so if you receive an invitation for the Phase 3 clinical trials, please do participate. Medicago Launches COVID-19 Vaccine Study in the UK Last week, the Medicago COVID-19 vaccine study launched at several sites across the UK.Medicago, a biopharmaceutical company based in Canada, and GlaxoSmithKline (GSK) are launching the Phase 3 randomised, observer blinded, placebo-controlled study. The NIHR-supported study is the first to test a plant-derived COVID-19 vaccine candidate, and will evaluate the efficacy and safety of the Coronavirus-Like Particle COVID-19 Vaccine (CoVLP).1,500 volunteers will be recruited to the study within the UK, and each will receive an active study vaccine dose as part of the trial’s blinded crossover design. Healthy adults between the age of 18 to 39-year-old will be asked to take part in the study, which will look to recruit over the course of the next four to six weeks.Email invitations are being sent via the COVID-19 Vaccine Research Registry, to those who meet the eligibility and area catchment criteria. Alternating vaccines study expands to include two additional vaccines Researchers running the Com-Cov study, launched in February to investigate alternating doses of the Oxford-AstraZeneca vaccine and the Pfizer vaccine, have announced the programme will be extended to include the Moderna and Novavax vaccines in a new study, Com-Cov2.Led by the University of Oxford, run across nine NIHR supported sites by the National Immunisation Schedule Evaluation Consortium, and backed through funding from the Vaccines Taskforce and the Coalition for Epidemic Preparedness Innovations, the additional study will seek to recruit adults aged over 50 who have received their first, or ‘prime’ vaccination in the past 8-12 weeks.There are expected to be 1050 volunteers across nine different sites in the trial, including: St George’s University Hospitals NHS Foundation Trust University Hospitals Birmingham NHS Foundation Trust The University of Nottingham Health Service Liverpool School of Tropical Medicine University College London Hospitals NHS Foundation Trust Hull University Teaching Hospitals NHS Trust The Newcastle Upon Tyne Hospitals NHS Foundation Trust Guy’s and St Thomas’ NHS Foundation Trust Sheffield Teaching Hospitals NHS Foundation Trust Find out more about the study by reading the full University of Oxford press release. Volunteers needed for study looking into whether COVID-19 and flu vaccines can be administered at the same time Researchers at the Bristol Trials Centre (CTEU) at the University of Bristol and University Hospitals Bristol and Weston NHS Foundation Trust (UHBW) are leading a new study which could set the foundations for how booster COVID-19 vaccinations are delivered in the future. The study, supported by the NIHR, will determine whether booster COVID-19 vaccines should be given at the same time as flu vaccines.While there are vaccines that have been approved to protect against COVID-19 in the UK, it is not yet known whether further booster doses may be required to give continued protection, and how giving boosters might fit in with the seasonal flu jab programme.From 29 March 2021, a study will look at the side effects and immune response given when people receive their COVID-19 booster and flu vaccine at the same appointment.To find out more, read the full news story. GenOMICC COVID-19 Study Volunteers Needed If you have had COVID-19, you can join the GenOMICC COVID-19 Study, which analyses the genes of people who have had the virus to discover why some experienced no symptoms while others became extremely ill is appealing for more volunteers.“We’re issuing an urgent appeal for more volunteers from all walks of life – and in particular for people from ethnic minority communities – to come forward and register as soon as possible,” explains Dr Kenneth Baillie, the study’s Chief Investigator. “We need to find people who tested positive for COVID but experienced either mild or no symptoms and didn’t require hospital treatment.”Scientists urgently need to recruit more people from all backgrounds – since many of the people who became really unwell were older, male or came from an ethnic minority we especially need to find people like them who had milder symptoms to join the study. Find out more by watching a short study animation. Volunteers can register online here. NHS COVID-19 vaccine research registry in numbers Up to date data can be found on the public dashboard including geographical breakdown of registrants. Be Part of Research Vaccine FAQs Check out the COVID-19 vaccines frequently asked questions page on our Be Part of Research website. Here you will find a number of FAQs that we are asked by members of the public. Some of the information might help answer your own questions too. The areas we are most commonly asked about are around:What is the advice for participants on trials who are offered a deployed vaccine?Participants on some vaccine trials may have been offered an active vaccine or a placebo (that offers no protection against COVID-19). Now approved vaccines are available from the NHS, we want to make sure participants are not put at a disadvantage, and are able to have protection as quickly as possible, while still gathering important data on the effectiveness of the trial vaccines. Arrangements are being put in place so that all participants can receive an active vaccine, together with extra monitoring in the trial environment. The trial team will be able to collect further data that will help demonstrate effectiveness. This is being done through a crossover trial appointment. The crossover trial will offer you the active vaccine being tested on your trial, and will be provided through the trial team rather than the normal NHS vaccine deployment.How does the crossover phase of a trial work?If you are already enrolled in a study, at your next trial visit (or sooner if you have already been offered the deployed vaccine), you will be offered an active vaccine if you received the placebo (dummy vaccine) initially. The trial team will contact you to offer you an appointment. If you are not called before you are offered a deployed vaccine, you can contact the trial team.Will supply of vaccines for the crossover trial be affected by any shortages affecting the national deployment?No, there are dedicated vaccine supplies for the crossover trial. You would not be affected by any shortages of supply affecting the national scheme. Welsh Version You can find this newsletter in Welsh. Withdraw your permissionIf you change your mind and would like to withdraw your permission to be contacted by researchers and NHS Digital about approved coronavirus vaccine studies, you can withdraw your permission on the Service website at any time. The sign-up service is delivered in partnership between the National Institute for Health Research and NHS Digital. The NIHR is working with equivalent NHS research partners in Northern Ireland, Scotland and Wales.