key: cord-1028917-joy452ml
authors: Chevallier, Patrice; Coste‐Burel, Marianne; Le Bourgeois, Amandine; Peterlin, Pierre; Garnier, Alice; Béné, Marie C.; Imbert, Berthe‐Marie; Drumel, Thomas; Le Gouill, Steven; Moreau, Philippe; Mahe, Beatrice; Dubruille, Viviane; Blin, Nicolas; Lok, Anne; Touzeau, Cyrille; Gastinne, Thomas; Jullien, Maxime; Vanthygem, Sophie; Guillaume, Thierry
title: Safety and immunogenicity of a first dose of SARS‐CoV‐2 mRNA vaccine in allogeneic hematopoietic stem‐cells recipients
date: 2021-06-01
journal: EJHaem
DOI: 10.1002/jha2.242
sha: 2ef86072b99a959fdb2ebf1e0dd15b51afed295a
doc_id: 1028917
cord_uid: joy452ml

This was a monocentric prospective study testing the efficacy and safety of a first injection of BNT162b2 (Pfizer‐BioNTech) in 112 Allo‐HSCT patients. Antibody response to SARS‐CoV‐2 spike protein receptor‐binding domain was tested at the time of the second injection (Roche Elecsys). The study also included a non‐randomized control arm of 26 healthy controls. This study shows that a first dose of SARS‐CoV‐2 messenger RNA vaccine is safe and provides a 55% rate of seroconversion in allotransplanted patients compared to 100% for the controls (p < 0.001). Factors influencing the absence of response in patients were recent transplantation (<2 years), lymphopenia (<1 × 10(9)/L) and immunosuppressive treatment or chemotherapy at the time of vaccination.

Blood samples were collected before the first and second injections. Previous asymptomatic COVID-19 infection was investigated in the first sample by testing for anti-nucleocapside (N) antibodies (anti-SARS-CoV-2 immunoassay, Roche Elecsys, Rotkreuz, Switzerland).

Antibody response to SARS-CoV-2 spike protein receptor-binding domain was tested at the time of the second injection (Roche Elecsys).

As recommended by the manufacturer, titers ≥ 0.8 U/ml were considered positive. We did not use other assays for antibody response. Possible associations between clinical characteristics and antibody response were investigated using chi-square and Wilcoxon tests with the R software via BiostaTGV. A p value < 0.05 was considered as statistically significant. Variable interactions were tested through multiple correspondence analyses (MCA) with XLSTAT (Paris, France).

Finally, all patients and controls were asked to complete a questionnaire to assess safety within the seven days following the first vaccination.

Patient characteristics are provided in Median IgG titers are given in Figure 1 

This study shows that 55% of Allo-HSCT recipients in this cohort developed anti-SARS-CoV-2 S protein antibodies after a first injection of [1] . This response after Allo-HSCT appears to be higher than that reported in solid organ transplantation recipients (17%) [7] , including renal transplantation (10.8%) [8] , or patients with CLL [9] . The good response of Allo-HSCT patients observed here also compares

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How to cite this article

Safety and immunogenicity of a first dose of SARS-CoV-2 mRNA vaccine in allogeneic hematopoietic stem-cells recipients

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008.

Informed consent was obtained from all patients for being included in the study.

We acknowledge the following individuals for their assistance with the study, none of whom were compensated for his or her contributions:The Hematology Department nurses Patricia Lespart, Ghislaine