As haematologists, we rarely treat patients of the demographic included in these vaccine clinical trials. In addition, there is a reporting bias within the literature favoured towards positive events, e.g. relapse AA. To study the impact of SARS-CoV-2 vaccination, a wider review for AA and/or PNH patients undergoing SARS-CoV-2 vaccination is proposed. You are kindly invited to join this study and contribute your patient data.
In view of the delays in vaccination in Europe, the registration period for this study has been extended to include all adult patients who have been invited for first vaccination by 30/06/2021.
Patient registration will close on 30/07/2021.
Patients are eligible if:
- they have been diagnosed with AA and/or PNH, irrespective of vaccination status;
- they are under active follow-up (to allow CRF completion);
- they have not yet undergone a bone marrow transplant.
Patients who are not eligible:
- Patients who have undergone bone marrow transplant;
- Paediatric patients due to vaccinations not currently being undertaken in this population, this may be revisited at a later date.
Please contact Anne Lippinkhof at saawpebmt@lumc.nl to receive the required study forms to register and submit your patients for this research study. Patient data can be submitted before or after vaccination of the patients has started.
Data will be collected with a follow-up of 3-, 6- and 12-months post first vaccination. For patients invited but not receiving vaccination, the reasons for this are of interest with a limited CRF completion at 3 months.
Because of the long follow-up, we would like to receive the CRF at two different timepoints: at 3 months and at 12 months post first vaccination. Please send your completed CRFs, password-secured, to Anne Lippinkhof at saawpebmt@lumc.nl.
On behalf of the IDWP and the SAAWP, thank you for your kind cooperation!
Morag Griffin – Principal Investigator
Peter Hillmen – International PNH interest Group and PNH registry Chair
Per Ljungman – Study Investigator
Anne Lippinkhof – SAAWP Study Coordinator
Dina Averbuch – IDWP Secretary
Rafael de la Camara – IDWP Chairperson
Antonio Risitano – SAAWP Secretary
Régis Peffault de Latour – SAAWP Chairperson