Evidence map›Paper›PMID 38848312›Full record

Trial reportThe Journal of infectious diseases2024

Antibody and T-Cell Response to Bivalent Booster SARS-CoV-2 Vaccines in People With Compromised Immune Function: COVERALL-3 Study.

Alain Amstutz, Frédérique Chammartin, Annette Audigé, Anna L Eichenberger, Dominique L Braun, Patrizia Amico, Marcel P Stoeckle, Barbara Hasse, Matthaios Papadimitriou-Olivgeris, Oriol Manuel and 21 more

Registry-linked trialAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of infectious diseases, 2024. 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 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. 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

31 authors.

Alain AmstutzDivision of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Frédérique ChammartinDivision of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Annette AudigéInstitute of Medical Virology, University of Zurich, Zurich, Switzerland.
Anna L EichenbergerDepartment of Infectious Diseases, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Dominique L BraunInstitute of Medical Virology, University of Zurich, Zurich, Switzerland.
Patrizia AmicoClinic for Transplantation Immunology and Nephrology, University Hospital Basel, Basel, Switzerland.
Marcel P StoeckleDivision of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, University of Basel, Basel, Switzerland.
Barbara HasseDepartment of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, Zurich, Switzerland.
Matthaios Papadimitriou-OlivgerisInfectious Diseases Service and Transplantation Center, Lausanne University Hospital, Lausanne, Switzerland.
Oriol ManuelInfectious Diseases Service and Transplantation Center, Lausanne University Hospital, Lausanne, Switzerland.ORCID 0000-0001-7607-0943
Cédric BongardDivision of Pulmonology, Department of Medicine, University Hospital of Lausanne, Lausanne, Switzerland.
Macé M SchuurmansDivision of Pulmonology, University Hospital Zurich, Zurich, Switzerland.
René HageDivision of Pulmonology, University Hospital Zurich, Zurich, Switzerland.
Dominik DammDivision of Pulmonology, University Hospital Zurich, Zurich, Switzerland.
Michael TammClinic of Respiratory Medicine and Pulmonary Cell Research, University Hospital Basel, Basel, Switzerland.
Nicolas J MuellerDepartment 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.ORCID 0000-0001-5297-6062
Huldrych F GünthardInstitute of Medical Virology, University of Zurich, Zurich, Switzerland.ORCID 0000-0002-1142-6723
Michael T KollerClinic for Transplantation Immunology and Nephrology, University Hospital Basel, Basel, Switzerland.
Christof M SchönenbergerDivision of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Alexandra GriessbachDivision of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Niklaus D LabhardtDivision of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Roger D KouyosInstitute of Medical Virology, University of Zurich, Zurich, Switzerland.
Alexandra TrkolaInstitute of Medical Virology, University of Zurich, Zurich, Switzerland.ORCID 0000-0003-1013-876X
Katharina KusejkoDepartment of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, Zurich, Switzerland.ORCID 0000-0002-4638-1940
Heiner C BucherDivision of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Irene A AbelaInstitute of Medical Virology, University of Zurich, Zurich, Switzerland.
Matthias BrielDivision of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.ORCID 0000-0002-2070-5230
Benjamin SpeichDivision of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.ORCID 0000-0002-3301-8085
Swiss HIV Cohort Study
Swiss Transplant Cohort

Funding

Janggen Pöhn FoundationModernaRocheSwiss National Science Foundation 31CA30_196245University of Basel
6 · The paper itself

Abstract

backgroundBivalent messenger RNA (mRNA) vaccines, designed to combat emerging severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants, incorporate ancestral strains and a new variant. Our study assessed the immune response in previously vaccinated individuals of the Swiss HIV Cohort Study (SHCS) and the Swiss Transplant Cohort Study (STCS) following bivalent mRNA vaccination.

methodsEligible SHCS and STCS participants received approved bivalent mRNA SARS-CoV-2 vaccines (mRNA-1273.214 or BA.1-adapted BNT162b2) within clinical routine. Blood samples were collected at baseline, 4 weeks, 8 weeks, and 6 months postvaccination. We analyzed the proportion of participants with anti-spike protein antibody response ≥1642 units/mL (indicating protection against SARS-CoV-2 infection), and in a subsample T-cell response (including mean concentrations), stratifying results by cohorts and population characteristics.

resultsIn SHCS participants, baseline anti-spike antibody concentrations ≥1642 units/mL were observed in 87% (96/112), reaching nearly 100% at follow-ups. Among STCS participants, 58% (35/60) had baseline antibodies ≥1642 units/mL, increasing to 80% at 6 months. Except for lung transplant recipients, all participants showed a 5-fold increase in geometric mean antibody concentrations at 4 weeks and a reduction by half at 6 months. At baseline, T-cell responses were positive in 96% (26/27) of SHCS participants and 36% (16/45) of STCS participants (moderate increase to 53% at 6 months). Few participants reported SARS-CoV-2 infections, side-effects, or serious adverse events.

conclusionsBivalent mRNA vaccination elicited a robust humoral response in individuals with human immunodeficiency virus (HIV) or solid organ transplants, with delayed responses in lung transplant recipients. Despite a waning effect, antibody levels remained high at 6 months and adverse events were rare. Clinical Trials Registration . NCT04805125.

Indexed as

Antibodies, ViralCOVID-19COVID-19 VaccinesImmunization, SecondarySARS-CoV-2T-Lymphocytes2019-nCoV Vaccine mRNA-1273AdultAgedAntibodies, NeutralizingBNT162 VaccineCohort StudiesFemaleHIV InfectionsHumansImmunocompromised Host2019-nCoV Vaccine mRNA-1273Antibodies, NeutralizingAntibodies, ViralBNT162 VaccineCOVID-19 VaccinesSpike Glycoprotein, Coronavirusbivalent vaccineHIVorgan transplantSARS-CoV-2vaccine

Identifiers

PMID38848312
PMCPMC11481330

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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.