Letters to participants

Letters to participants of the Novavax COVID-19 vaccine trial.

Letter to participants Mar 2021

For participants enrolled into the Novavax COVID-19 vaccine trial at our Trust:
(2019nCov-302_Letter to participants_PCR Kit Relabelling, 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

  1. Each subject will get one sealed envelope containing three new return labels and three purple kit stickers
  2. Wash your hands with soap and warm water for 20 seconds.
  3. Each time you do a test, apply 1 white Royal Mail return label and 1 purple sticker on the return box
  4. Stick 1 white Royal Mail return label on the return box. You must cover the old return label, if there’s already one there.
  5. Stick 1 purple sticker onto any free space on the return box.
  6. Once these new return labels are received confirm the acknowledgement back to sites
  7. 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

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,

The Study team
Chelsea and Westminster Hospital
Clinical Research Facility

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