key: cord-0931457-u8ftubo0
authors: Kamar, Nassim; Abravanel, Florence; Marion, Olivier; Couat, Chloé; Izopet, Jacques; Del Bello, Arnaud
title: Three Doses of an mRNA Covid-19 Vaccine in Solid-Organ Transplant Recipients
date: 2021-06-23
journal: N Engl J Med
DOI: 10.1056/nejmc2108861
sha: 8e7796ed359ab5de4cdcd083081159cc7e32e38c
doc_id: 931457
cord_uid: u8ftubo0

nan

1 Appendix As we have previously reported 1 , when the vaccination campaign started (7 January 2021), all our transplant-patients were invited to be vaccinated. Due to weak immunogenicity of 2doses of mRNA-based anti-SARS-CoV-2 vaccines, the French National Authority for Health recommended (4 April 2021) the use of a third dose in immunosuppressed patients 2 . This dose had to be given at least one month after the second dose or as soon as possible in patients in whom the second dose was administrated more than one month before this latter recommendation. Hence, all our seropositive or seronegative transplant patients were invited to receive the third dose.

According to the recommendations of the Francophone Society of Transplantation 3 , anti-SARS-CoV-2 spike protein antibodies were monitored before and after vaccination.

Furthermore, the French authorities recommended that anti-SARS-CoV-2 serologies be performed in immunosuppressed patients 4 . Therefore, all our patients were also invited to perform a serology according to the national recommendations. In the present letter we collected retrospectively the outcome of the first 101 consecutive patients who have been given 3 doses and who have had their anti-SARS-CoV-2 spike protein antibodies assessed.

According to French law (loi Jardé), anonymous retrospective studies do not require institutional review board approval. However, the study approved by the research department of our institution (Approval provided).

We used the Wantai microplate ELISA that detect total anti-SARS-Cov-2 antibodies (IgG, IgM and IgA) (WANTAI SARS-CoV-2 Ab ELISA). Semi-quantitative results are expressed as signal-tocut-off ratio (S/C0). Patients were considered as positive if S/Co> 1.1. Samples with a S/C0> 47 were retested after dilution. Using this assay, we have previously reported a 100% specificity and 100% sensitivity in immunocompetent patients tested at 2 to 14 days post symptom-onset and at 15 to 45 days post symptom-onset, suggesting it as the ability to detect low level of antibodies 5 .

We compared responders to non-responders after 3-doses vaccine (see supplementary Table   1 ). Non-responders were older, had a lower total lymphocyte count, a lower CD4-positive Tcell count, a lower CD19-positive count, and a lower estimated glomerular filtration rate before vaccination compared to responders. The proportion of patients given belatacept was higher among non-responders.

No serious adverse events were reported. However, 10 patients who were seropositive before the third dose presented with fatigue and myalgia. Five patients presented transient fever. Ni gastro-intestinal side effects were observed. 

Messenger RNA Vaccines in Recipients of Solid Organ Transplants

Clinical performance of a rapid test compared to a microplate test to detect total anti SARS-CoV-2 antibodies directed to the spike protein