Important information for participants in light of COVID-19 vaccine deployment

Important information for patients and the public

Thank you for your interest in COVID-19 vaccine research.

The Pfizer/BioNTech, Oxford/AstraZeneca and Moderna vaccines are now being rolled out across the UK.

These developments are a tribute to the global efforts of the life sciences industry, researchers and volunteers, underlining the importance of this vaccine research. It is thanks to you and all those involved, that we have this encouraging news about vaccines.

It is important that clinical trials into a number of other COVID-19 vaccines continue. Different vaccines work in different ways and we still need to collect important information about which vaccines work best, and are best for different groups of people, and on exactly how effective they are at, for example, preventing severe infection, preventing infection as a whole, preventing transmission etc. We also need information on matters such as the best way to use vaccines, the number of doses, and to check long term that there are no safety concerns.

Keep taking part

It is really important that people keep taking part in all the COVID-19 studies, attending their follow-up appointments and submitting data on their health and COVID infections. We need volunteers to join new studies and existing studies are not yet complete, and we need the long term data to help us understand how best to use the vaccines, which are most effective and to give information on the levels of effectiveness, as well as reassurance on long term safety of them.

Here are some answers to questions you might have about what these developments mean for the clinical study you are taking part in.

Approved COVID-19 Vaccines

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.

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, who will make you an appointment. Older participants or those who are eligible for the deployed vaccine now are being prioritised. You still have the choice to unblind (find out whether you have had the active trial vaccine or a placebo) and if you had the placebo, you can choose to book an appointment with the NHS for an approved vaccine.

I’m in a special sub-group, an earlier phase trial or the monoclonal antibody studies. Does this advice apply to me?

There may be different advice for people on some of the special or earlier phase trials. In particular, people on earlier phase trials where there isn’t the same amount of information available about the likely effectiveness of the trial vaccine may be advised to have the approved vaccine on top of the trial vaccine. If you have had the monoclonal antibodies (Provent or Stormchaser trials), it is important that you speak to the trial team for further advice.

Do we still need people to take part in COVID vaccine trials?

Yes, the trials will continue because we need data about a number of different vaccines and their safety and effectiveness, in order to protect the population.

We need several vaccines to ensure an adequate supply and because some vaccines may be easier to transport and store than others. We need further data on whether one or other vaccine is better suited to specific groups of people, such as older people or people with other medical conditions, and all the trials are giving information on safety, which is so important to gather.

Thank you for your participation - it is thanks to people taking part in trials that we now have approved vaccines.

What will the roll out of the approved vaccines mean for the trials?

The NHS are contacting people in an agreed priority order in the coming weeks and months to be vaccinated. We would want everyone taking part in the trials to be protected, alongside the rest of the population. Your safety is our highest priority. Processes are being put in place within studies to make sure trial participants are protected either through the approved vaccine or the trial vaccine.

Is it worth me joining a clinical trial now that we have approved vaccines?

It’s a personal choice but we believe it is. There is a process in place so people on the study are not disadvantaged. All the studies now recruiting will give you an active vaccine during the trial. Taking part in a study is the best way to help effective vaccines to be identified and made available to everyone earlier, and may even give you early access to a vaccine later found to be effective.

I'm on a clinical trial and in a priority group for vaccination, how will I be offered early protection?

Now that approved vaccines are available, people in priority groups will be contacted by the NHS and offered an appointment to receive it.

From February 2021, this includes people over 70, health and care workers and people who are extremely clinically vulnerable, and is being rolled out by age to younger people. When you are invited to a vaccine, please contact the research team, who will follow an agreed process to advise you. This is likely to include finding out whether you received an active trial vaccine or a placebo (that would offer you no protection against COVID-19), called ‘unblinding’.

If you had an active vaccine, the research team will advise you if you still need to have the approved vaccine, taking into account the latest data on the trial vaccine’s effectiveness. If you had a placebo, you will be advised to have the approved vaccine.

Please continue to attend follow-up appointments and the advice of the research team, so that we can gather important safety information about the trial vaccine. It will be important that we gather information about the safety and effectiveness of all the trial vaccines underway. This is so that we can gather information to allow use of all the effective vaccines, to maximise supply and ensure that we gain a full picture of the effectiveness and use of all the vaccines available.

I’m on a clinical trial and not in a priority group for vaccination, what does this mean for me?

Please continue to take part in the clinical trials, attend for your follow-up booster (if applicable), and all your follow-up appointments. We are asking people to continue to take part in clinical research for as long as possible.

I've been called up for my COVID-19 vaccine by the NHS but I am on a trial. What should I do?

Please contact the research team, who will advise. If you have been on a placebo controlled trial (meaning some participants will have no protection), there are two options. One is an ‘unblinding’ process, which means finding out whether you received an active trial vaccine or a placebo. The other is to wait for the crossover trial, which means offering the participants who were on the placebo arm, the active trial vaccine.

Important: Whether you are on the placebo or active vaccine trial arm, and whether you have an approved vaccine or not, please continue to attend follow-up appointments and take the advice of the research team, so that we can gather important safety information about the trial vaccine. This is so that we can gather information to allow use of all the effective vaccines, to maximise supply and ensure that we gain a full picture of the effectiveness and use of all the vaccines available.

I’d prefer to have an approved vaccine, on top of a full course of the active trial vaccine. Is this advisable?

If you have received the full trial dose or doses, you will be advised NOT to have an approved vaccine (which is the current national guidance from the independent expert group). This is because the risks of receiving the approved vaccine after a full dose of trial vaccine are unknown and also because there is a good expectation that the active trial vaccine could protect you. It is very important to speak to the research team as only they can help you with the key information on the risks and benefits of your options.

The current vaccine trials have studied the benefits and safety of individual vaccines. We do not have evidence for the benefit and safety or risks of having an additional vaccine over and above the trial doses, so the risks are unknown. There may be a risk of increased side-effects, such as pain at the injection site and flu-like symptoms. If you choose to have an additional course of vaccines, it is advisable to ensure there is an adequate gap between vaccines and the trial team could advise on the appropriate time.

What will happen to people on the trials when they become eligible for an approved vaccine?

There are two types of trials, those testing against a placebo (that offers no protection against COVID-19), and those testing against an active vaccine (that is hoped will be effective or may have already been approved as effective). All trials now recruiting in the UK will be looking at active vaccines, meaning all participants will be offered an active vaccine during the trial. Some of the active vaccines in some of these trials have not yet been approved, and their effectiveness has not been fully evaluated.

Participants who were recruited into the Novavax and Janssen studies have a choice as to how they receive an active vaccine. They can go through an unblinding process, and if they received a placebo, they can choose to receive an approved vaccine through the NHS. Alternatively, they can stay on the trial and be offered an active trial vaccine through the crossover trial.

What if I want to leave the clinical trial as a result of the vaccine roll out?

Participants are free to leave at any time, and this is a personal choice. If you are anxious about staying in the trial, do speak to the research team who can probably help you with any concerns and help you with information about leaving. We would encourage people to stay in the trials until they are called up for an approved vaccine, and to continue with the follow up appointments after that. The longer people are in trials, the more data can be gathered, and the earlier the trials can complete, and hopefully produce more data on effectiveness of the vaccines.

Unblinding

I’ve been unblinded and told I’ve been given the active trial vaccine. What does this mean for me?

When you are unblinded, you will be supported with further advice. If you have received the full trial dose or doses, you will be advised not to have the approved vaccine (which is the current national guidance from the independent expert group).

This is because the risks of receiving the approved vaccine after a full dose of trial vaccine are unknown and also because there is a good expectation that the active trial vaccine could protect you. As more evidence from the trial is developed, further advice may be offered to you if necessary. Please continue with the follow-up appointments.

I had the placebo vaccine, what should I do?

If you are advised that you were given the placebo and are subsequently called up for the approved COVID-19 vaccine, it is recommended that you take this up. The placebo will not give you any protection against COVID-19. Please continue to attend your trial appointments.

Can antibody tests reveal whether I received an active vaccine or placebo?

No. Antibody tests have been developed to give an idea of whether someone has had coronavirus infection (even if they had no symptoms). However many of these tests look at antibodies to parts of the coronavirus that are not contained within the vaccines. Therefore you may have had an excellent response to the vaccine and be protected from infection, but the antibody tests will be negative.

An antibody test should not be used to determine if you have had active vaccine or placebo in a trial, or to see how good a response you have had to a vaccine, as they cannot reliably provide this information.

Crossover Trials

What is a crossover trial?

This type of trial offers participants who were on the placebo arm, the same active vaccine that is being trialled. You will receive the vaccine from the trial team, rather than through the NHS vaccine deployment service. The trial team will contact you to offer you an appointment. At the appointment, if you received the placebo vaccine (the dummy vaccine), you will be offered an effective active vaccine. This will allow the trial team to collect more data without participants going through the unblinding process and receiving an approved vaccine from the NHS.

How does the crossover phase of a trial work?

You do not have to do anything at this stage. 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. This is expected to start from late March. 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.

How will participants on crossover trials be protected from Covid?

At a future time-point, participants will be offered the chance to have the active trial vaccine if they had the placebo initially. This is called a 'crossover' trial. It means that all participants will get the benefit of the active trial vaccine, together with extra monitoring in the trial environment. The trial team will be able to collect further data that will help demonstrate effectiveness. There would not be a need for participants to unblind and come off the trial to receive an active vaccine.

Which vaccine will I be offered on the crossover trial and is it approved?

You will be offered the same active vaccine as on your trial (so the Novavax vaccine for the Novavax trial). The approval process is underway for a number of these vaccines at the moment, but may not have been completed. Your trial team can give you further information on the latest status.

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.

If you have further questions about vaccine studies please visit our frequently asked questions page or visit approved vaccine studies.

You can find more information about how to get involved in other types of COVID-19 research and how it affects people in minority ethnic communities on our site.