BNT162b2 vaccination in heart transplant recipients: Clinical experience and antibody response

Peled, Yael; Ram, Eilon; Lavee, Jacob; Sternik, Leonid; Segev, Amit; Wieder‐Finesod, Anat; Mandelboim, Michal; Indenbaum, Victoria; Levy, Itzchak; Raanani, Ehud; Lustig, Yaniv; Rahav, Galia

doi:10.1016/j.healun.2021.04.003

Cited by 119 publications

(159 citation statements)

References 9 publications

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“…Compared with previously published data on the seropositivity rate after vaccination of other immunosuppressed populations, such as patients who received heart or renal transplantation, the seropositivity rate of patients with cancer in our study was higher (18–37.5% vs 84%, respectively) [ [15] , 16 , 17 , 18 ].…”

Section: Discussioncontrasting

confidence: 86%

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Efficacy and safety of BNT162b2 vaccination in patients with solid cancer receiving anticancer therapy – a single centre prospective study

Shmueli

Itay

Margalit

et al. 2021

European Journal of Cancer

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Aim Patients with cancer are at an increased risk for severe coronavirus disease of 2019, thus data on the safety and efficacy of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccines are essential. We conducted this prospective study of patients with cancer vaccinated with BNT162b2 and monitored for antibody response and safety. The aim was to evaluate the rate of seropositivity and define predictors for non-reactive immune response. Furthermore, we evaluated the frequency and the severity of adverse events. Methods The study included patients with solid tumours undergoing anticancer treatment and immunocompetent health-care workers serving as controls. Serum titres of the receptor-binding domain (RBD) immunoglobulin G (IgG) and neutralising antibodies were measured 2–4 weeks after each vaccine dose. Results The analysis included 129 patients, of which 70.5% patients were metastatic. Patients were treated with chemotherapy (55%), immunotherapy (34.1%), biological agents (24.8%), hormonal treatment (8.5%) and radiotherapy (4.6%), that were given either alone or in combinations. The seropositivity rate among patients with cancer and controls was 32.4% versus 59.8% (p < 0.0001) after the first dose and 84.1% versus 98.9% (p < 0.0001) after the second dose, respectively. Median RBD-IgG titre was lower among patients than controls (p < 0.0001). Patients who were seronegative after the second dose had significantly more comorbidities than that with patients with seropositivity (77.8% vs 41.1%, respectively, p = 0.0042). Conclusion Adequate antibody response after BNT162b2 vaccination was achieved after two doses but not after one dose, in patients with cancer vaccinated during anticancer therapy.

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Section: Discussioncontrasting

confidence: 86%

“…[ 14 ]. Data regarding safety and efficacy of mRNA COVID-19 vaccines in patients who were immune-compromised [ [15] , 16 , 17 , 18 ] and oncology patients [ [19] , 20 , 21 , [22] , 23 ] are now beginning to emerge.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of BNT162b2 vaccination in patients with solid cancer receiving anticancer therapy – a single centre prospective study

Shmueli

Itay

Margalit

et al. 2021

European Journal of Cancer

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“…Our finding of an association of immune paresis with the use of mycophenolate expend on the previously reported correlations following the second dose, 2 , 3 but should be carefully interpreted before any clinical actions carried out, given the potential hazardous implications associated with withdrawal of antimetabolite therapy. 3 The enhanced immune response demonstrated in our study following the third booster dose and the association with lower mycophenolate use might shed light on the previously observed more robust immune response in lung transplant patients after COVID-19 in contrast to the minimal response following vaccination.…”

Section: Discussionsupporting

confidence: 54%

“…In the general population, 1 the two-dose protocol for SARS-CoV-2 mRNA vaccines has been shown to elicit an excellent antibody response, but in SOT recipients antibody responses after 2 doses are markedly attenuated. 2 , 3 This attenuated antibody response translates into a clinical picture that includes breakthrough infections in fully vaccinated (2 doses) transplant recipients, 4 with the disease course being comparable to that in non-vaccinated SOT recipients. 5…”

Section: Introductionmentioning

confidence: 99%

Third dose of the BNT162b2 vaccine in heart transplant recipients: Immunogenicity and clinical experience

Peled

Ram

Lavee

et al. 2022

The Journal of Heart and Lung Transplantation

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BACKGROUND The repeated waves of the COVID-19 pandemic have highlighted the necessity to optimize vaccine responses in immunocompromised populations. We investigated the safety and immunogenicity of a third, booster, dose of the Pfizer BNT162b2 vaccine in heart transplant (HT) patients. METHODS The cohort comprised 96 adult HT patients who received a third homologous dose of the BNT162b2 vaccine 168 days after the second dose. The vaccine-induced antibody responses of both receptor-binding domain (RBD) IgG and neutralizing antibodies were assessed in all patients, with a positive antibody response being defined as the presence of either IgG anti-RBD or neutralizing antibodies. For a subset of patients, T cell response was also studied. RESULTS The third dose was associated with a low rate of adverse events, mostly mild pain at the injection site. No serious adverse events were recorded, and there were no episodes of rejection. At 18 days following the third dose of the vaccine, the positive antibody response increased from 23% to 67%, with a corresponding increase in neutralizing capacity. The third dose elicited SARS-CoV-2 neutralization titers >9-fold and IgG anti-RBD antibodies >3-fold of the range achieved after the two primary doses. Mycophenolate use, lower eGFR and higher C-reactive protein were independently associated with a reduced likelihood of generating an immune response. Importantly, a specific T-cell response following the third dose was evident in the majority of transplant recipients. CONCLUSIONS An homologous third booster dose of the BNT162b2 vaccine gave overall consistent tolerability and a good safety profile, while eliciting humoral and cellular immune responses.

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“…Indeed, studies have experimentally shown that serum from vaccinated individuals is less efficient in neutralizing viral variants [17,18]. On the other hand, post-vaccination infection may occur if vaccineinduced immunity is absent or ineffective, such as in solid organ transplant (SOT) recipients who are receiving immunosuppressive therapy [19][20][21][22][23][24]. Here we describe the characteristics of fourteen SARS-CoV-2 infections in fully vaccinated individuals at our medical center between 29 March 2021 and 29 April 2021 that represent both of these scenarios.…”

Section: Introductionmentioning

confidence: 99%

Breakthrough Infections with Multiple Lineages of SARS-CoV-2 Variants Reveals Continued Risk of Severe Disease in Immunosuppressed Patients

Deng

Evdokimova

O’Brien

et al. 2021

Viruses

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The pandemic of COVID-19 caused by SARS-CoV-2 infection continues to spread around the world. Vaccines that elicit protective immunity have reduced infection and mortality, however new viral variants are arising that may evade vaccine-induced immunity or cause disease in individuals who are unable to develop robust vaccine-induced responses. Investigating the role of viral variants in causing severe disease, evading vaccine-elicited immunity, and infecting vulnerable individuals is important for developing strategies to control the pandemic. Here, we report fourteen breakthrough infections of SARS-CoV-2 in vaccinated individuals with symptoms ranging from asymptomatic/mild (6/14) to severe disease (8/14). High viral loads with a median Ct value of 19.6 were detected in the nasopharyngeal specimens from subjects regardless of disease severity. Sequence analysis revealed four distinct virus lineages, including alpha and gamma variants of concern. Immunosuppressed individuals were more likely to be hospitalized after infection (p = 0.047), however no specific variant was associated with severe disease. Our results highlight the high viral load that can occur in asymptomatic breakthrough infections and the vulnerability of immunosuppressed individuals to post-vaccination infections by diverse variants of SARS-CoV-2.

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BNT162b2 vaccination in heart transplant recipients: Clinical experience and antibody response

Cited by 119 publications

References 9 publications

Efficacy and safety of BNT162b2 vaccination in patients with solid cancer receiving anticancer therapy – a single centre prospective study

Efficacy and safety of BNT162b2 vaccination in patients with solid cancer receiving anticancer therapy – a single centre prospective study

Third dose of the BNT162b2 vaccine in heart transplant recipients: Immunogenicity and clinical experience

Breakthrough Infections with Multiple Lineages of SARS-CoV-2 Variants Reveals Continued Risk of Severe Disease in Immunosuppressed Patients

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