Evidence map›Paper›PMID 34347934›Full record

ArticleAmerican journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons2021

Humoral and cellular immune response and safety of two-dose SARS-CoV-2 mRNA-1273 vaccine in solid organ transplant recipients.

Victoria G Hall, Victor H Ferreira, Matthew Ierullo, Terrance Ku, Tina Marinelli, Beata Majchrzak-Kita, Anila Yousuf, Vathany Kulasingam, Atul Humar, Deepali Kumar

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05280158 (Phase I/II, Open-Label Dose-Finding Trial of High-Dose mRNA-1273 Booster for Lung Transplant Recipients), which is not on this map. Cited by 100 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
100citing papers in PubMed, 9 pooled it
9.2field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05280158 phase1 / phase2terminatednot on this mapstarted 2022, after this paper: background citation

Phase I/II, Open-Label Dose-Finding Trial of High-Dose mRNA-1273 Booster for Lung Transplant Recipients

TypeinterventionalSponsorUniversity of California, Los AngelesRan2022 to 2023Enrolled19ConditionsLung Transplant Recipient, SARS-CoV-2, ImmunosuppressionArmsmRNA-1273 (Moderna COVID-19 vaccine)
3 · Its place in the literature

Who cites it

100 citing papers in PubMed, 9 syntheses or guidelines pooled it, 155 citations in OpenAlex.

  1. Immunogenicity of COVID-19 vaccines in solid organ transplant recipients: a systematic review and meta-analysis.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2023
    Pooled it
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  3. Humoral and cellular response of COVID-19 vaccine among solid organ transplant recipients: A systematic review and meta-analysis.Transplant infectious disease : an official journal of the Transplantation Society · 2022
    Pooled it
  4. Pooled it
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  6. COVID-19 and solid organ transplantation: Finding the right balance.Transplantation reviews (Orlando, Fla.) · 2022
    Pooled it
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  8. Immunological and clinical efficacy of COVID-19 vaccines in immunocompromised populations: a systematic review.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2022
    Pooled it
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40 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 1 institution in 1 country.

Victoria G HallTransplant Infectious Diseases and Ajmera Transplant Centre, University Health Network, Toronto, Canada.ORCID 0000-0001-9353-0059
Victor H FerreiraTransplant Infectious Diseases and Ajmera Transplant Centre, University Health Network, Toronto, Canada.
Matthew IerulloTransplant Infectious Diseases and Ajmera Transplant Centre, University Health Network, Toronto, Canada.
Terrance KuTransplant Infectious Diseases and Ajmera Transplant Centre, University Health Network, Toronto, Canada.ORCID 0000-0002-6757-3757
Tina MarinelliTransplant Infectious Diseases and Ajmera Transplant Centre, University Health Network, Toronto, Canada.
Beata Majchrzak-KitaTransplant Infectious Diseases and Ajmera Transplant Centre, University Health Network, Toronto, Canada.
Anila YousufTransplant Infectious Diseases and Ajmera Transplant Centre, University Health Network, Toronto, Canada.
Vathany KulasingamLaboratory Medicine Program, University Health Network, Toronto, Canada.
Atul HumarTransplant Infectious Diseases and Ajmera Transplant Centre, University Health Network, Toronto, Canada.
Deepali KumarTransplant Infectious Diseases and Ajmera Transplant Centre, University Health Network, Toronto, Canada.ORCID 0000-0003-1961-0477
University Health Network · CA

Funding

Ajmera Transplant Centre, TorontoPublic Health Agency of Canada through the COVID-19 Immunity Task Force and Vaccine Surveillance Reference Group
6 · The paper itself

Abstract

Solid organ transplant recipients are at high risk of severe disease from COVID-19. We assessed the immunogenicity of mRNA-1273 vaccine using a combination of antibody testing, surrogate neutralization assays, and T cell assays. Patients were immunized with two doses of vaccine and immunogenicity assessed after each dose using the above tests. CD4+ and CD8+ T cell responses were assessed in a subset using flow-cytometry. A total of 127 patients were enrolled of which 110 provided serum at all time points. A positive anti-RBD antibody was seen in 5.0% after one dose and 34.5% after two doses. Neutralizing antibody was present in 26.9%. Of note, 28.5% of patients with anti-RBD did not have neutralizing antibody. T cell responses in a sub-cohort of 48 patients showed a positive CD4+ T cell response in 47.9%. Of note, in this sub-cohort, 46.2% of patients with a negative anti-RBD, still had a positive CD4+ T cell response. The vaccine was safe and well-tolerated. In summary, immunogenicity of mRNA-1273 COVID-19 vaccine was modest, but a subset of patients still develop neutralizing antibody and CD4+T- cell responses. Importantly polyfunctional CD4+T cell responses were observed in a significant portion who were antibody negative, further highlighting the importance of vaccination in this patient population. IRB Statement: This study was approved by the University Health Network Research Ethics Board (CAPCR ID 20-6069).

Indexed as

COVID-19Organ TransplantationAntibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesHumansImmunity, CellularSARS-CoV-2Antibodies, NeutralizingAntibodies, ViralCOVID-19 Vaccinesclinical research/practiceinfection and infectious agents - viralinfectious diseasevaccine

Identifiers

PMID34347934
PMCPMC8441872
OpenAlexW3193143175

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.