Evidence map›Paper›PMID 39624496›Full record

ArticleThe Lancet regional health. Europe2025

Humoral and cellular responses to a fifth bivalent SARS-CoV-2 vaccine dose in patients with immune-mediated inflammatory diseases on tumour necrosis factor inhibitors: a prospective cohort study.

Hilde S Ørbo, Taissa de Matos Kasahara, Asia-Sophia Wolf, Kristin H Bjørlykke, Joseph Sexton, Ingrid Jyssum, Anne T Tveter, Guri Solum, Ingrid Fadum Kjønstad, Sabin Bhandari and 14 more

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Article in The Lancet regional health. Europe, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

24 authors.

Hilde S ØrboCenter for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway.
Taissa de Matos KasaharaInstitute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.
Asia-Sophia WolfSection of Immunology, Norwegian Institute of Public Health, Oslo, Norway.
Kristin H BjørlykkeDepartment of Gastroenterology, Akershus University Hospital, Lørenskog, Norway.
Joseph SextonCenter for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway.
Ingrid JyssumCenter for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway.
Anne T TveterCenter for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway.
Guri SolumSection of Immunology, Norwegian Institute of Public Health, Oslo, Norway.
Ingrid Fadum KjønstadSection of Immunology, Norwegian Institute of Public Health, Oslo, Norway.
Sabin BhandariSection of Immunology, Norwegian Institute of Public Health, Oslo, Norway.
Ingrid E ChristensenCenter for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway.
Tore K KvienCenter for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway.
Andreas LindDepartment of Microbiology, Oslo University Hospital, Oslo, Norway.
Hassen KaredInstitute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.
Jørgen JahnsenInstitute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.
Espen A HaavardsholmCenter for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway.
Ludvig A MuntheInstitute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.
Sella A ProvanCenter for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway.
John T VaageInstitute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.
Siri MjaalandSection of Immunology, Norwegian Institute of Public Health, Oslo, Norway.
Silje Watterdal SyversenCenter for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway.
Kristin K JørgensenDepartment of Gastroenterology, Akershus University Hospital, Lørenskog, Norway.
Gunnveig GrødelandInstitute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.
Guro Løvik GollCenter for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: As most people now have established hybrid immunity, the need for regular, updated SARS-CoV-2 vaccine boosters in patients with immune-mediated inflammatory diseases (IMIDs) is unclear. The study aim was to assess humoral and cellular immunogenicity of a fifth bivalent vaccine dose in patients with IMID on tumour necrosis factor inhibitors (TNFi). Methods: In the longitudinal, observational Nor-vaC study, we assessed anti-spike and neutralising antibodies against Wuhan, Omicron BA.1 and BA.4, as well as frequency and polyfunctionality of responding T cells, following a fourth monovalent and a fifth bivalent (BA.1 or BA.4/5) vaccine dose in patients with or without hybrid immunity using TNFi. Findings: Between December 17, 2021, and June 20, 2023, 456 infection-naïve patients with IMIDs using TNFi received a fourth vaccine dose and were otherwise eligible for inclusion. A total of 373/456 (82%) received a fifth vaccine dose, of these 190/373 (51%) had hybrid immunity defined as having had COVID-19 between the fourth and fifth dose. In patients with hybrid immunity, the fifth dose did not induce improved humoral responses compared to infection, neither with BA.1 (median anti-spike antibody concentrations 23,244 IU/ml (IQR 15,138-45,233) vs 36,341 IU/ml (11,887-53,710), p = 0.52) nor BA.4/5 (31,693 IU/ml (15,176-54,186), p = 0.30). Comparison of neutralising antibodies yielded similar results. In infection-naïve patients, a fifth BA.4/5 vaccine, but not the BA.1, induced slightly higher humoral responses (18,890 IU/ml (6494-50,211)) compared to the fourth dose (7304 IU/ml (3245-17,260), p < 0.0001). CD8 T cell responses remained stable following a fourth dose (median frequency of spike-specific cells 0.039% (IQR 0.010-0.14)), infection (0.058% (0.026-0.17)) and a fifth dose (0.058% (0.013-0.20). Interpretation: In patients on TNFi with hybrid immunity, there was no immunological benefit of an updated fifth SARS-CoV-2 booster dose. Stable CD8 cellular responses following four doses indicate established protective immunity. Patients whose only risk factor is TNFi may in future follow vaccine recommendations for the general population. Funding: The South-Eastern Norway Regional Health Authority, The Coalition for Epidemic Preparedness Innovations (CEPI), Diakonhjemmet Hospital, Akershus University Hospital, Oslo University Hospital, University of Oslo, The Norwegian Research Council.

Indexed as

COVID-19Inflammatory arthritisInflammatory bowel diseaseNeutralising antibodiesSARS-CoV-2T cellsTNF inhibitorsTumour necrosis factor inhibitorVaccination

Identifiers

PMID39624496
PMCPMC11609505

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Registered trials

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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.