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Multicenter Study
. 2022 May 7;15(1):54.
doi: 10.1186/s13045-022-01275-7.

SARS-CoV-2 vaccine response and rate of breakthrough infection in patients with hematological disorders

José Luis Piñana  1   2 , Lucia López-Corral  3 , Rodrigo Martino  4 , Lourdes Vazquez  3 , Ariadna Pérez  5   6 , Gabriel Martin-Martin  3 , Beatriz Gago  7 , Gabriela Sanz-Linares  8 , Andrés Sanchez-Salinas  9 , Lucia Villalon  10 , Venancio Conesa-Garcia  11 , María T Olave  12 , Magdalena Corona  13 , Sara Marcos-Corrales  3 , Mar Tormo  5   6 , José Ángel Hernández-Rivas  14 , Juan Montoro  15 , Alicia Rodriguez-Fernandez  16 , Irene Risco-Gálvez  17 , Pablo Rodríguez-Belenguer  18 , Juan Carlos Hernandez-Boluda  5   6   19 , Irene García-Cadenas  4 , Montserrat Ruiz-García  20 , Juan Luis Muñoz-Bellido  21 , Carlos Solano  5   6   19 , Ángel Cedillo  22 , Anna Sureda  8 , David Navarro  6   23 ; Infectious Complications Subcommittee of the Spanish Hematopoietic Stem Cell Transplantation and Cell Therapy Group (GETH-TC)
Affiliations
Multicenter Study

SARS-CoV-2 vaccine response and rate of breakthrough infection in patients with hematological disorders

José Luis Piñana et al. J Hematol Oncol. .

Abstract

Background: The clinical efficacy of SARS-CoV-2 vaccines according to antibody response in immunosuppressed patients such as hematological patients has not yet been established.

Patients and methods: A prospective multicenter registry-based cohort study conducted from December 2020 to December 2021 by the Spanish transplant and cell therapy group was used to analyze the relationship of antibody response at 3-6 weeks after full vaccination (2 doses) with breakthrough SARS-CoV-2 infection in 1394 patients with hematological disorders.

Results: At a median follow-up of 165 days after complete immunization, 37 out of 1394 (2.6%) developed breakthrough SARS-CoV-2 infection at median of 77 days (range 7-195) after full vaccination. The incidence rate was 6.39 per 100 persons-year. Most patients were asymptomatic (19/37, 51.4%), whereas only 19% developed pneumonia. The mortality rate was 8%. Lack of detectable antibodies at 3-6 weeks after full vaccination was the only variable associated with breakthrough infection in multivariate logistic regression analysis (Odds Ratio 2.35, 95% confidence interval 1.2-4.6, p = 0.012). Median antibody titers were lower in cases than in non-cases [1.83 binding antibody units (BAU)/mL (range 0-4854.93) vs 730.81 BAU/mL (range 0-56,800), respectively (p = 0.007)]. We identified 250 BAU/mL as a cutoff above which incidence and severity of the infection were significantly lower.

Conclusions: Our study highlights the benefit of developing an antibody response in these highly immunosuppressed patients. Level of antibody titers at 3 to 6 weeks after 2-dose vaccination links with protection against both breakthrough infection and severe disease for non-Omicron SARS-CoV-2 variants.

Keywords: Allogeneic stem cell transplantation; Autologous stem cell transplantation; Breakthrough SARS-CoV-2 infection; COVID-19; Correlates of protection; Hematological malignancies; Immunocompromised patients; Moderna mRNA-1273; Pfizer-BioNTech BNT162b2; SARS-CoV-2 vaccines; Vaccine.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Median anti-SARS-CoV-2 IgG-reactive antibodies titers measured in binding antibody units/mL (BAU/mL) at 3–6 weeks after the 2nd dose according to pre-vaccination SARS-CoV-2 infection. Patients with SARS-CoV-2 infection prior to vaccination (n = 109) had a median of 2550 BAU/mL (range 0–10,400) vs those without prior history of SARS-CoV-2 infection (n = 1118) median 493.6 BAU/mL (range 0–6338.6) (p < 0.0001)
Fig. 2
Fig. 2
Median anti-SARS-CoV-2 IgG-reactive antibody titers measured in binding antibody units/mL (BAU/mL) at 3–6 weeks after the 2nd dose according to SARS-CoV-2 breakthrough infection. Patients who did not developed SARS-CoV-2 infection (n = 1207) had a median of 730.81 BAU/mL (range 0–58,600) vs 1.83 BAU/mL (range 0–4854.93) in those who did develop breakthrough infection (n = 27) (p = 0.007)
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References

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Supplementary concepts