Evidence map›Paper›PMID 35234868›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2022

Antibody Response in Immunocompromised Patients After the Administration of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccine BNT162b2 or mRNA-1273: A Randomized Controlled Trial.

Benjamin Speich, Frédérique Chammartin, Irene A Abela, Patrizia Amico, Marcel P Stoeckle, Anna L Eichenberger, Barbara Hasse, Dominique L Braun, Macé M Schuurmans, Thomas F Müller and 11 more

Registry-linked trialOpen access · bronzeAbstract readAdaptive Clinical TrialEquivalence TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04805125 (Randomised Controlled Trials to Assess Approved SARS-CoV-2 Vaccines in Immunocompromised Patients), which is not on this map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
3.8field-weighted citation impact, top 5% 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.

NCT04805125 phase3completednot on this map

Randomised Controlled Trials to Assess Approved SARS-CoV-2 Vaccines in Immunocompromised Patients: A Master Protocol for the Set-up of a Swiss Cohorts Based Trial Platform

TypeinterventionalSponsorUniversity Hospital, Basel, SwitzerlandRan2021 to 2023Enrolled610ConditionsImmunocompromised PatientsArmsModerna COVID-19 Vaccine, mRNA-1273 (100 μg), Pfizer-BioNTech COVID-19 Vaccine BNT162b2 (30 µg)( Comirnaty®)
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 1 synthesis or guideline pooled it, 38 citations in OpenAlex.

  1. Pooled it
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  12. The immune response to SARS-CoV-2 in people with HIV.Cellular & molecular immunology · 2024
    Review
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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

21 authors at 4 institutions in 3 countries.

Benjamin SpeichBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Frédérique ChammartinBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Irene A AbelaUniversity of Zurich, Institute of Medical Virology, Zurich, Switzerland.
Patrizia AmicoClinic for Transplantation Immunology and Nephrology, University Hospital Basel, University of Basel, Basel, Switzerland.
Marcel P StoeckleDivision of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, University of Basel, Switzerland.
Anna L EichenbergerDepartment of Infectious Diseases, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Barbara HasseDivision of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, Zurich, Switzerland.
Dominique L BraunUniversity of Zurich, Institute of Medical Virology, Zurich, Switzerland.
Macé M SchuurmansDivision of Pulmonology, University Hospital Zurich, Zurich, Switzerland.
Thomas F MüllerNephrology Clinic, University Hospital Zurich, Zürich, Switzerland.
Michael TammClinic of Respiratory Medicine and Pulmonary Cell Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Annette AudigéUniversity of Zurich, Institute of Medical Virology, Zurich, Switzerland.
Nicolas J MuellerDivision of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, Zurich, Switzerland.
Andri RauchDepartment of Infectious Diseases, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Huldrych F GünthardUniversity of Zurich, Institute of Medical Virology, Zurich, Switzerland.
Michael T KollerSwiss Transplant Cohorts Study, University Hospital Basel, University of Basel, Basel, Switzerlandand.
Alexandra TrkolaUniversity of Zurich, Institute of Medical Virology, Zurich, Switzerland.
Matthias BrielBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Katharina KusejkoUniversity of Zurich, Institute of Medical Virology, Zurich, Switzerland.
Heiner C BucherBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Swiss HIV Cohort Study and the Swiss Transplant Cohort Study
University of Basel · CHUniversity of Zurich · CHUniversity Hospital of Zurich · CHUniversity of Bern · CH

Funding

Swiss National Science Foundation 177499
6 · The paper itself

Abstract

backgroundBNT162b2 by Pfizer-BioNTech and mRNA-1273 by Moderna are the most commonly used vaccines to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. Head-to-head comparison of the efficacy of these vaccines in immunocompromised patients is lacking.

methodsParallel, 2-arm (allocation 1:1), open-label, noninferiority randomized clinical trial nested into the Swiss HIV Cohort Study and the Swiss Transplant Cohort Study. People living with human immunodeficiency virus (PLWH) or solid organ transplant recipients (SOTR; ie, lung and kidney) from these cohorts were randomized to mRNA-1273 or BNT162b2. The primary endpoint was antibody response to SARS-CoV-2 spike (S1) protein receptor binding domain (Elecsys Anti-SARS-CoV-2 immunoassay, Roche; cutoff ≥0.8 units/mL) 12 weeks after first vaccination (ie, 8 weeks after second vaccination). In addition, antibody response was measured with the Antibody Coronavirus Assay 2 (ABCORA 2).

resultsA total of 430 patients were randomized and 412 were included in the intention-to-treat analysis (341 PLWH and 71 SOTR). The percentage of patients showing an immune response was 92.1% (95% confidence interval [CI]: 88.4-95.8; 186/202) for mRNA-1273 and 94.3% (95% CI: 91.2-97.4; 198/210) for BNT162b2 (difference: -2.2%; 95% CI: -7.1 to 2.7), fulfilling noninferiority of mRNA-1273. With the ABCORA 2 test, 89.1% had an immune response to mRNA-1273 (95% CI: 84.8-93.4; 180/202) and 89.5% to BNT162b2 (95% CI: 85.4-93.7; 188/210). Based on the Elecsys test, all PLWH had an antibody response (100.0%; 341/341), whereas for SOTR, only 60.6% (95% CI: 49.2-71.9; 43/71) had titers above the cutoff level.

conclusionsIn immunocompromised patients, the antibody response of mRNA-1273 was noninferior to BNT162b2. PLWH had in general an antibody response, whereas a high proportion of SOTR had no antibody response.

Indexed as

COVID-19Viral Vaccines2019-nCoV Vaccine mRNA-1273Antibodies, ViralBNT162 VaccineCohort StudiesHumansImmunocompromised HostSARS-CoV-2Viral Envelope Proteins2019-nCoV Vaccine mRNA-1273Antibodies, ViralBNT162 VaccineViral Envelope ProteinsViral VaccinesHIVorgan transplantplatform trialrandomized controlled trialSARS-CoV-2vaccine

Identifiers

PMID35234868
PMCPMC8903480
OpenAlexW4214708501

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.