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BNT162b2 mRNA COVID-19 vaccination in immunocompromised patients: A prospective cohort study.
Rahav, Galia; Lustig, Yaniv; Lavee, Jacob; Magen, Hila; Hod, Tammy; Shmueli, Einat Shacham; Ben-Ari, Ziv; Halperin, Rebecca; Indenbaum, Victoria; Olmer, Liraz; Huppert, Amit; Mor, Eytan; Regev-Yochay, Gili; Cohen, Carmit; Finesod, Anat Wieder-; Levy, Itzchak.
  • Rahav G; The Infectious Diseases Unit, Sheba Medical Center, Tel Hashomer, Israel.
  • Lustig Y; Sackler Faculty of Medicine, Tel-Aviv University, Israel.
  • Lavee J; Sackler Faculty of Medicine, Tel-Aviv University, Israel.
  • Ohad Benjamini; Central Virology Laboratory, Ministry of Health and Sheba Medical Center, Tel-Hashomer, Israel.
  • Magen H; Sackler Faculty of Medicine, Tel-Aviv University, Israel.
  • Hod T; Leviev Cardiothoracic and Vascular Center, Sheba Medical Center, Tel-Hashomer, Israel.
  • Noga Shem-Tov; Sackler Faculty of Medicine, Tel-Aviv University, Israel.
  • Shmueli ES; Division of Hematology and Bone-Marrow Transplantation, Sheba Medical Center, Tel Hashomer, Israel.
  • Drorit Merkel; Sackler Faculty of Medicine, Tel-Aviv University, Israel.
  • Ben-Ari Z; Division of Hematology and Bone-Marrow Transplantation, Sheba Medical Center, Tel Hashomer, Israel.
  • Halperin R; Sackler Faculty of Medicine, Tel-Aviv University, Israel.
  • Indenbaum V; Nephrology Department, Sheba Medical Center, Tel Hashomer, Israel.
  • Olmer L; Sackler Faculty of Medicine, Tel-Aviv University, Israel.
  • Huppert A; Division of Hematology and Bone-Marrow Transplantation, Sheba Medical Center, Tel Hashomer, Israel.
  • Mor E; Sackler Faculty of Medicine, Tel-Aviv University, Israel.
  • Regev-Yochay G; Oncology Division, Sheba Medical Center, Tel Hashomer, Israel.
  • Cohen C; Sackler Faculty of Medicine, Tel-Aviv University, Israel.
  • Finesod AW; Division of Hematology and Bone-Marrow Transplantation, Sheba Medical Center, Tel Hashomer, Israel.
  • Levy I; Sackler Faculty of Medicine, Tel-Aviv University, Israel.
EClinicalMedicine ; 41: 101158, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1466282
ABSTRACT

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.

Full text: Available Collection: International databases Database: MEDLINE Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Language: English Journal: EClinicalMedicine Year: 2021 Document Type: Article Affiliation country: J.eclinm.2021.101158

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Language: English Journal: EClinicalMedicine Year: 2021 Document Type: Article Affiliation country: J.eclinm.2021.101158