Safety and Immunogenicity of the BNT162b2 mRNA Covid-19 Vaccine in Patients after Allogeneic HCT or CD19-based CAR-T therapy

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INFECTIOUS DISEASE

Medical writer: Coco Chong | Last updated: 20 July 2021 | In: COVID-19, Infectious Disease, Vaccines

Article Keywords

immune response, CAR-T, COVID-19, BioNTech, BNT162b2, SARS-CoV-2, COVID-19 vaccination, haematopoietic cell transplantation, Pfizer

In this single centre prospective cohort study, the efficacy and toxicity of BNT162b2 vaccine were evaluated in patients who underwent haematopoietic cell transplantation (HCT) and chimeric antigen receptor T-cell (CAR-T) therapy.¹

A total of 79 eligible patients who received HCT (n = 65) and CAR-T therapy (n = 14) were enrolled and evaluated for immunologic recovery on CD19+, CD4+, and CD8+ cell blood levels. Vaccination was suggested based on the European Society for Blood and Marrow Transplantation recommendations. All patients were vaccinated with the BNT162b2 Coronavirus Disease 2019 (COVID-19) vaccine, which yielded 94.6% efficacy in a phase 3 study.²

The median age of patients was 65 years, and the median time from infusion of cells to vaccination were 32 months versus (vs) 9 months in the allogeneic HCT group vs CAR-T therapy group, respectively. In the HCT group, 62% of patients had active chronic graft vs host disease, and 58% were receiving immune suppressive therapy with mostly calcineurin inhibitors. Complete B-cell aplasia was observed in 11% of the overall patients. The overall antibody responses were 86% in HCT patients and 79% in CAR-T patients, which has proven to be efficacious among immunocompromised patients.

Serology testing found that 82% of patients in HCT group developed immunogenicity. However, the humoral response rate was only 36% in the CAR-T group. Adverse events that were grade 3 or higher occurred in 4.6% and 7% in the two groups, respectively. Although the adverse events resolved quickly in most cases, one secondary graft rejection occurred and was being investigated.

A multivariate analysis showed that factors associated with a positive humoral response included increased amount of time from the infusion of cells (p=0.032), female sex (p=0.028), and a higher number of CD19-positive cells (p=0.047). Higher numbers of CD19-positive cells and CD4 cells were predictive of positive ELISpot cellular response (p=0.49 and p=0.041).

The BNT162b2 mRNA COVID-19 vaccine showed promising immunogenicity in patients after allogeneic HCT or CAR-T therapy, but humoral response in CAR-T patients with B cell aplasia was more encouraging in allogeneic HCT group compared to CAR-T therapy. Adverse events were mostly mild and transient, so the vaccine is safe to use in immunosuppressed patients, but a longer follow-up and close monitoring of patients are required to test the persistence of antibodies.

Reference

Ram R, et al. Abstract S285. Presented at EHA 2021.

Polack FP, et al. N Engl J Med. 2020; 383(27)2603–2615

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Disclaimer

This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).