Letters to participants
Letters to participants of the Novavax COVID-19 vaccine trial
Letter to UK trial participants 21 Oct 2021 (Novavax)
For participants in the NVX-CoV2373 UK Phase 3 clinical trial at the Trust
Dear Novavax Participant,
In line with Government and the JCVI guidance we are able to assist our Novavax participants who wish to receive an approved NHS vaccination (read more).
If you wish to receive the approved NHS vaccine to enable travel:
- You will be asked to attend a final study visit where we will take the final blood sample, you will be unblinded (if applicable), you will have a discussion with the doctor, and we will direct you to the nearest vaccination hub to access your NHS vaccine.
- Please note that this has to be a personal decision made by you in discussion with a doctor who is part of the team supporting your trial.
- Please let us know via phone or email if you wish to receive an NHS approved vaccination.
Regarding NHS boosters:
- We are not offering a booster as part of the trial.
- In line with government guidance, you may accept the booster jab from your GP/local vaccine site when offered in line with your priority group.
- Please let us know via phone or email if you are offered an NHS approved booster and we are happy to discuss the process further with you.
If you do not require an NHS approved vaccine at this time or have already been in contact with the study team regarding this, then there is no action required at this point. You can attend your final appointment as originally planned and you will receive a reminder email closer to the time.
Kind Regards,
Clinical Research Facility
Chelsea and Westminster Hospital
Letter to UK trial participants 17 Sep 2021 (Novavax)
For participants in the UK Phase 3 clinical trial at the Trust
Dear participant,
Please see the letter from Novavax, the sponsor of the NVX-CoV2373 clinical trial, on the UK COVID-19 vaccine Phase 3 clinical trial.
With kind regards,
CW Research Team
Letter to UK trial participants 9 Aug 2021 (received by site on 16 Sep 2021) (Novavax)
For participants in the UK Phase 3 clinical trial at the Trust
Dear participant,
Thank you for participating in our NVX-CoV2373 clinical trial. We understand that if you wish to travel abroad, there might be additional costs for PCR testing as part of international country entry requirements. Novavax has agreed to reimburse you for the cost associated with required PCR testing.
The reimbursement will cover foreign travel related PCR tests performed from 17 May 2021 onwards up to a maximum of two tests up to the value of £100 per test (£200 total) upon provision of receipt of payment. Please contact your study site if you would like to be reimbursed. For regulatory reasons an updated informed consent will be required, your study site will arrange this with you.
Thank you again for your participation and your patience.
Sincerely,
Novavax
Letter to UK trial participants Aug 2021 (Novavax)
For participants enrolled into the Novavax vaccine trial at our Trust
Dear participant
Please see the letter from Novavax, the sponsor of the NVX-CoV2373 clinical trial on proof of vaccine status and international recognition.
With kind regards
CW Research Team
Letter to participants July 2021 (VALNEVA)—information about test offer required for international travel
For participants enrolled into the VALNEVA COVID-19 vaccine trial at our Trust
Dear participant
Please see the letter from Valneva, the sponsor of the Valneva Trial VLA2001-301. If you want to take up this offer, please contact the Trial Team for more information.
With kind regards
Valneva Study Team
Letter to participants July 2021 (Novavax)—phase 3 results lay summary
For participants enrolled into the Novavax COVID-19 vaccine trial at our Trust (revised 1 Jul 2021)
Dear participant
Thank you for your participation in the UK Novavax COVID-19 vaccine trial. We are pleased to report that the first results from this trial will be published in the New England Journal of Medicine.
Summary of results
Background
The earlier Novavax (NVX) Phase 1/2 trials had indicated that the NVX vaccine was safe and showed a good immune response against the Covid-19 virus. The UK Phase 3 trial was designed to show if the vaccine was also safe when given to large numbers of people and could actually protect them (provide “efficacy”) against Covid-19.
Trial results
In total 15,187 participants were recruited. 27% were older than 65 years. Half of the participants (7,569) were randomised to receive the NVX vaccine, and the other half (7,570) to receive the placebo (normal saline water). 400 participants were also recruited into an “Influenza Sub-study” to look at the results when the NVX vaccine was given at the same time as an influenza vaccine. The results of this will be published separately.
Safety
2,310 participants were asked to complete an electronic diary for 7 days after each vaccine and to record any symptoms. Overall, those who received the NVX vaccine reported more injection site symptoms than those who received the placebo: around 58% vs. 18% after the first dose and 80% vs. 16% after the 2nd dose. These were mainly tenderness and pain, lasting around 2-3 days after each dose. Headache, muscle pain and fatigue were also reported (more commonly after the 2nd dose: each at around 40%) and again were short-lived (average of 2 days). Across the whole study “serious” adverse events were very rare and were equal in both the vaccine and the saline placebo groups (0.6%). There were no serious allergic reactions.
Efficacy
There were 10 cases of symptomatic Covid-19 from 7 or more days after the 2nd dose of the Novavax vaccine (none required hospitalisation), as compared with 96 cases after the placebo (89.7% efficacy). Most of the cases (66) were caused by the Kent variant (B.1.1.7, now called the alpha variant), and the efficacy was 86.3% against this variant. The vaccine was equally effective in all age groups, including those ³65 years old, and in those with a range of other health problems.
Summary
In summary, two doses of the NVX vaccine provides around 90% protection against symptomatic Covid-19 and appears to be safe. We look forward to reporting more results to you after a longer period of followup. We are highly appreciative of the ongoing contributions of all our participants in this trial.
More information for all those participating in vaccine trials can be found on the Be Part of Research website.
Letter to participants July 2021 (Novavax)—vaccine certification
For participants enrolled into the Novavax COVID-19 vaccine trial at our Trust (1 Jul 2021)
Dear participant
You'll be aware from reports in the media that there could be plans for COVID-status certification (sometimes referred to as ‘vaccine passports’). These would allow an individual to demonstrate that they have been vaccinated, tested or have natural immunity. This could be used to give them access to certain places or events like concerts or football matches, or with the agreement of other countries, to travel internationally. The review is ongoing and no final decision on whether domestic certification will go ahead has been confirmed at the time of writing (13 May).
NIHR (National Institute for Health Research) are in discussions with the Government about the inclusion of all trial participants who have received an active vaccine to be included in this. This would mean if you were on the Novavax trial, and had received a cross-over vaccine, or been unblinded and had had an active vaccine, you would be included. There is no need for you to take any action at this stage or to request unblinding. We are working on a system so that all the information from the trial team about whether you had received a cross-over vaccine, or been unblinded and had an active vaccine, will flow through automatically. We are very keen to make sure trial participants are not disadvantaged and to reduce the need for participants to request unblinding. We will issue further information as soon as there are further developments.
Letter to participants March 2021 (Novavax)
For participants enrolled into the Novavax COVID-19 vaccine trial at our Trust (12 Mar 2021)
Dear Novavax Vaccine Trial Participant
Thank you for continuing to send your swabs when you develop possible COVID-19 symptoms.
In order to make sure your swabs are processed at the correct laboratories for the Novavax trial there is a minor change to the way you send your swabs. You will shortly be receiving an envelope from your trial site containing white Royal Mail stickers and instructions about how to apply these to your swab kits. Please start using these as soon as you receive them.
By doing this it will allow the continued processing of swabs by the same laboratories, ensuring testing consistency throughout the trial and also allows viral samples to be sequenced to look for mutant strains.
These envelopes have been packed by Royal Mail, but your name and address are applied by your trial site. Your personal details have not been shared.
Please also contact your trial site if your postal address requires updating.
Please see further instructions below.
Subject instructions to relabel the existing PCR kits
- Each subject will get one sealed envelope containing three new return labels and three purple kit stickers
- Wash your hands with soap and warm water for 20 seconds.
- Each time you do a test, apply 1 white Royal Mail return label and 1 purple sticker on the return box
- Stick 1 white Royal Mail return label on the return box. You must cover the old return label, if there’s already one there.
- Stick 1 purple sticker onto any free space on the return box.
- Once these new return labels are received confirm the acknowledgement back to sites
- For more questions/concerns in this regard please reach out to your site staff and they should be able to help you in this regard.
Many thanks for your continued participation in the trial.
Clinical Research Team
St Stephen’s Centre
Chelsea and Westminster Hospital
07825 681 110
Letter to participants Feb 2021 (Novavax)
For participants enrolled into the Novavax COVID-19 vaccine trial at our Trust
(2019nCov-302_Letter to participants_Cross-over vaccinations_V1.0, 1 Feb 2021]
Dear participant
We are very pleased to inform you that a recent press release from Novavax has reported that the Novavax COVID-19 vaccine demonstrates 89.3% efficacy in the UK trial. It is important to note that these results are based on an interim analysis and your continued study participation is crucial for our end of study final analysis. Even with these results it is important to continue the study for its full duration to collect information on special groups, like those older than 65 years of age, as well as long-term safety data in all participants. We are extremely grateful for your contribution to this important trial.
We are aware that many of you are being offered appointments for the nationally deployed licensed COVID-19 vaccines and we will continue to unblind you in this situation if you wish to receive a licensed vaccine.
However, we would like to inform you that there are now plans to modify this current trial to offer participants the opportunity to take part in ‘cross-over’ vaccinations.
In the proposed cross-over visits you will be offered either two doses of the Novavax COVID-19 vaccine (if you haven’t received them already) or the placebo (if you have received the Novavax COVID-19 vaccine already). You would remain ‘blinded’—meaning that you will not know whether you received the Novavax COVID-19 vaccine in the first ‘part’ of the study or in the ‘second’ part of the study, but this ensures that you will receive 2 doses of the Novavax COVID-19 vaccine which we now know to be effective.
Your continued participation in this study in this way will not only ensure you receive a Novavax vaccine but will also assist in maintaining the integrity of this important study. Details of this process will be sent to you in the coming weeks. Please note this would require that you voluntarily decline the licensed vaccine if it is offered to you.
We thank you again for your contribution.
With kind regards
Study Team
Chelsea and Westminster Hospital
Clinical Research Facility
caw-tr.crf@nhs.net