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  • Saeed D
  • Feldman D
  • Banayosy AE
  • Birks E
  • Blume E
  • et al.
J Heart Lung Transplant. 2023 Jul;42(7):e1-e222 doi: 10.1016/j.healun.2022.12.004.
  • Velleca A
  • Shullo MA
  • Dhital K
  • Azeka E
  • Colvin M
  • et al.
J Heart Lung Transplant. 2023 May;42(5):e1-e141 doi: 10.1016/j.healun.2022.10.015.
  • Peled Y
  • Ram E
  • Mandelboim M
  • Lavee J
  • Sternik L
  • et al.
Am J Transplant. 2022 Jul;22(7):1931-1932 doi: 10.1111/ajt.16998.
  • Peled Y
  • Ram E
  • Lavee J
  • Segev A
  • Matezki S
  • et al.
J Heart Lung Transplant. 2022 Feb;41(2):148-157 doi: 10.1016/j.healun.2021.08.010.
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.

  • Rahav G
  • Lustig Y
  • Lavee J
  • Ohad Benjamini
  • Magen H
  • et al.
BACKGROUND:

Trials of the Pfizer-BioNTech BNT162b2 mRNA vaccine showed 95% efficacy in preventing symptomatic disease; however, the trials excluded immunocompromised patients (ICPs). We aim at analyzing antibody response in ICPs.

METHODS:

A prospective cohort study was conducted at Sheba Medical Center, Israel, between January and April 2020, in 1274 participants who received the vaccine, including 1002 ICPs and 272 immunocompetent healthcare workers (HCWs). Antibodies were measured two-four weeks after vaccination by SARS-CoV-2 anti-receptor binding domain IgG antibodies (RBD IgG) and pseudo-virus neutralization assays. Multivariable logistic regression analyses were used to identify factors associated with vaccine-induced antibody response. Adverse events (AEs) were monitored.

FINDINGS:

RBD-IgG antibodies were detected in 154/156 (98.7%) of patients with HIV, 75/90 (83.3%) with solid malignancies, 149/187 (79.7%) with myeloma, 83/111 (74.8%) following hematopoietic stem cell transplants, 25/36 (69.4%) following liver transplantation, 26/43 (60.5%) with myelodysplastic syndrome, 96/188 (51.0%) with chronic lymphocytic leukemia/non-Hodgkin's lymphoma, 50/110 (45.5%) following kidney transplantation, 15/80 (18.8%) following heart transplantation, and 269/272 (98.9%) in controls. There was a significant correlation r = 0.74 (95%CI 0.69,0.78) between RBD-binding IgG and neutralizing antibodies in all groups. Multivariate logistic regression analysis showed that age > 65 years (OR 0.41,95%CI 0.30,0.57) and underlying immunosuppression (OR 0.02,95%CI 0.01,0.07) were significantly associated with a non-reactive response of IgG antibodies. HIV patients showed a similar immunological response as healthy adults. The vaccine was safe without any episodes of rejection, graft-versus-host disease (GVHD) or allergy. Immunocompetent HCWs experienced significantly more AEs than ICPs.

INTERPRETATION:

Antibody response to the Pfizer-BioNTech vaccine was highly variable among different ICPs; thus, individual recommendations should be provided for the different immunosuppression states.

  • Peled Y
  • Ram E
  • Lavee J
  • Sternik L
  • Segev A
  • et al.
The Journal of Heart and Lung Transplantation. 2021;40(8):759-762 doi: 10.1016/j.healun.2021.04.003.
Data on the safety and efficacy of SARS-CoV-2 vaccines in immunocompromised populations are sparse. We conducted a prospective study of 77 heart transplant (HT) recipients vaccinated with two doses of BNT162b2 vaccine and monitored for adverse events following both doses, the receptor-binding domain (RBD) IgG response, and neutralizing antibodies. BNT162b2 vaccination was associated with a low rate of adverse events, characterized mostly by pain at the injection site. By a mean 41 days post second dose there were no clinical episodes of rejection, as suggested by a troponin leak or allograft dysfunction. At a mean 21 days following the second dose, IgG anti-RBD antibodies were detectable in 14 (18%) HT recipients. Immune sera neutralized SARS-CoV-2 pseudo-virus in 8 (57%) of those with IgG anti-RBD antibodies. Immunosuppressive regimen containing mycophenolic acid was associated with lower odds of an antibody response (OR=0.12, P=0.042). Whether a longer time-frame for observation of an antibody response is required after vaccination in immunosuppressed individuals remains unknown.
  • Rogers WA
  • Lavee J
The Journal of Heart and Lung Transplantation. 2020;39(6):614-615 doi: 10.1016/j.healun.2020.04.014.
The Journal of Heart and Lung Transplantation (JHLT) has maintained a policy of not publishing papers that do not comply with the 2007 ethics statement of the International Society for Heart and Lung Transplantation (ISHLT), which states: “Obtaining organs for transplantation from the bodies of executed prisoners contravenes the principle of voluntary donation.”1 Authors are required to indicate that their research complies with the ISHLT policy. The clause pertaining to executed prisoners is particularly significant for Chinese authors as China is the only country where widespread, state-sanctioned procurement of organs from prisoners has occurred and may still be occurring.