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Observational Study
. 2023 Mar;29(3):274-280.
doi: 10.1016/j.jiac.2022.11.010. Epub 2022 Nov 26.

Humoral response and safety of the BNT162b2 and mRNA-1273 COVID-19 vaccines in allogeneic hematopoietic stem cell transplant recipients: An observational study

Masashi Nishikubo  1 , Yoshimitsu Shimomura  2 , Hayato Maruoka  3 , Seiko Nasu  3 , Tomomi Nishioka  4 , Kenji Sakizono  3 , Satoshi Mitsuyuki  1 , Tomoyo Kubo  1 , Naoki Okada  1 , Daishi Nakagawa  1 , Kimimori Kamijo  1 , Hiroharu Imoto  1 , Ryusuke Yamamoto  1 , Yuya Nagai  1 , Nobuhiro Hiramoto  1 , Satoshi Yoshioka  1 , Noboru Yonetani  1 , Akiko Matsushita  1 , Chisato Miyakoshi  5 , Asako Doi  6 , Takayuki Ishikawa  1
Affiliations
Free PMC article
Observational Study

Humoral response and safety of the BNT162b2 and mRNA-1273 COVID-19 vaccines in allogeneic hematopoietic stem cell transplant recipients: An observational study

Masashi Nishikubo et al. J Infect Chemother. 2023 Mar.
Free PMC article

Abstract

Background: The effectiveness of mRNA COVID-19 vaccines and the optimal timing of vaccine administration in allogeneic hematopoietic stem cell transplantation (Allo-HSCT) recipients remains inadequately investigated. We examine the effectiveness and safety of mRNA COVID-19 vaccines in allo-HSCT recipients.

Method: This prospective observational study included 44 allo-HSCT recipients and 38 healthy volunteers. The proportion of subjects acquiring anti-S1 IgG antibodies were considered as the primary endpoint. The occurrence of adverse events after vaccination and objective deterioration of chronic graft-versus-host disease (GVHD) were defined as secondary endpoints. In addition, we compared the geometric mean titers (GMT) of anti-S1 antibody titers in subgroups based on time interval between transplantation and vaccination.

Results: A humoral response to the vaccine was evident in 40 (91%) patients and all 38 healthy controls. The GMT of anti-S1 titers in patients and healthy controls were 277 (95% confidence interval [CI]: 120-643) BAU/mL and 532 (95% CI 400-708) BAU/mL, respectively. (p = 0.603). A short time interval between transplantation and vaccination (≤6 months) was associated with low anti-S1 IgG antibody titers. No serious adverse events and deterioration of chronic GVHD were observed. Only one case of new development of mild chronic GVHD was recorded.

Conclusion: Messenger RNA COVID-19 vaccines induce humoral responses in allo-HSCT recipients and can be administered safely.

Keywords: Allogeneic; COVID-19; SARS-CoV-2; Transplantation; Vaccine.

Conflict of interest statement

Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Anti-S1 antibody titers in allo-HSCT recipient subgroup divided by time interval between transplantation and vaccination (≤6 months and >6 months) and healthy volunteers. The geometric mean titers of anti-S1 titers in patients and healthy controls were 277 (95% confidence interval [CI]: 120–643) BAU/mL and 532 (95%CI 400–708) BAU/mL (P = 0.603), respectively. Black dotted lines indicate 7.1 BAU/mL, the cut-off value of serologic reactions according to the manufacturer's instructions. P-value was calculated using the Mann–Whitney U test.
Fig. 2
Fig. 2
(a and b) Adverse events reported after the first and second dose of mRNA vaccines. The percentage of responders among (a) allo-HSCT recipients and (b) healthy volunteers declaring one or more adverse events. (c) Change in NIH chronic GVHD scores at inclusion (before vaccination) and blood sampling after two doses of vaccines. Among 44 patients, only 2 patients exhibited deteriorated NIH score (red lines). One case exhibited worsened performance status (NIH score five to seven) due to lung abscess caused by bacterial infection and was not relevant to the exacerbation of chronic GVHD. The other (NIH score zero to one) was a case of newly developed skin rash that required topical steroid ointment application. Among other 42 patients, NIH scores of the remaining 42 patients were either stable (gray lines) or improved (blue lines).
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