Evidence map›Paper›PMID 34635537›Full record

ArticleBMJ open2021

Immunosuppression reduction when administering a booster dose of the BNT162b2 mRNA SARS-CoV-2 vaccine in kidney transplant recipients without adequate humoral response following two vaccine doses: protocol for a randomised controlled trial (BECAME study).

Dafna Yahav, Benaya Rozen-Zvi, Tiki Mashraki, Alaa Atamna, Haim Ben-Zvi, Erez Bar-Haim, R Rahamimov

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04961229 (Booster Dose of mRNA SARS-CoV-2 Vaccine for Kidney Transplant Recipients Without Adequate Humoral Response With or Without Immunosuppression Reduction - Protocol for a Randomised Controlled Trial), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
1.4field-weighted citation impact, top 15% 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.

NCT04961229 phase4unknown statusnot on this map

Booster Dose of mRNA SARS-CoV-2 Vaccine for Kidney Transplant Recipients Without Adequate Humoral Response With or Without Immunosuppression Reduction - Protocol for a Randomised Controlled Trial (BECAME Study)

TypeinterventionalSponsordafna yahavRan2021 to 2022Enrolled504ConditionsCOVID-19 Acute Respiratory Distress Syndrome, ImmunosuppressionArmsThe Pfizer mRNA-based BNT162b2 vaccine
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 24 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Third dose of the BNT162b2 vaccine in cardiothoracic transplant recipients: predictive factors for humoral response.Clinical research in cardiology : official journal of the German Cardiac Society · 2023
    Article
  5. Observational
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Review
  16. Article
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

7 authors at 3 institutions in 1 country.

Dafna Yahav *Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel dafna.yahav@gmail.com.ORCID 0000-0003-3181-9791
Benaya Rozen-Zvi *Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
Tiki MashrakiDepartment of Nephrology and Hypertension, Rabin Medical Center, Petah Tikva, Israel.
Alaa AtamnaSackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
Haim Ben-ZviClinical Microbiology Laboratory, Rabin Medical Center, Beilinson Hospital, Petah-Tikva, Israel.
Erez Bar-HaimDepartment of Biochemistry and Molecular Genetics, Israel Institute for Biological Research, Ness Ziona, Israel.ORCID 0000-0003-3435-8599
R RahamimovSackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
Tel Aviv University · ILRabin Medical Center · ILIsrael Institute for Biological Research · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionInadequate antibody response to mRNA SARS-CoV-2 vaccination has been described among kidney transplant recipients. Immunosuppression level and specifically, use of antimetabolite in the maintenance immunosuppressive regimen, are associated with inadequate response. In light of the severe consequences of COVID-19 in solid organ transplant recipients, we believe it is justified to examine new vaccination strategies in these patients. METHODS AND ANALYSIS: BECAME is a single-centre, open-label, investigator-initiated randomised controlled, superiority trial, aiming to compare immunosuppression reduction combined with a third BNT162b2 vaccine dose versus third dose alone. The primary outcome will be seropositivity rate against SARS-CoV-2. A sample size of 154 patients was calculated for the seropositivity endpoint assuming 25% seropositivity in the control group and 50% in the intervention group. A sample of participants per arm will be also tested for T-cell response. We also plan to perform a prospective observational study, evaluating seropositivity among ~350 kidney transplant recipients consenting to receive a third vaccine dose, who are not eligible for the randomised controlled trial. ETHICS AND DISSEMINATION: The trial is approved by local ethics committee of Rabin Medical Center (RMC-0192-21). All participants will be required to provide written informed consent. Results of this trial will be published; trial data will be available. Protocol amendments will be submitted to the local ethics committee. TRAIL REGISTRATION NUMBER: NCT04961229.

Indexed as

COVID-19Kidney TransplantationVaccinesBNT162 VaccineCOVID-19 VaccinesEquivalence Trials as TopicHumansImmunosuppression TherapyObservational Studies as TopicRandomized Controlled Trials as TopicRNA, MessengerSARS-CoV-2Treatment OutcomeBNT162 VaccineCOVID-19 VaccinesRNA, MessengerVaccinesCOVID-19immunologyrenal transplantation

Identifiers

PMID34635537
PMCPMC8506046
OpenAlexW3205968259

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.