Evidence map›Paper›PMID 35235002›Full record

Trial reportJournal of neurology2022

Immune response to the third COVID-19 vaccine dose is related to lymphocyte count in multiple sclerosis patients treated with fingolimod.

Anat Achiron, Mathilda Mandel, Michael Gurevich, Sapir Dreyer-Alster, David Magalashvili, Polina Sonis, Mark Dolev, Shay Menascu, Gil Harari, Shlomo Flechter and 1 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of neurology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 3 pooled it
6.5field-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.

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

29 citing papers in PubMed, 3 syntheses or guidelines pooled it, 44 citations in OpenAlex.

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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

11 authors at 1 institution in 1 country.

Anat AchironNeuroimmunology Laboratory at the Multiple Sclerosis Center, Sheba Medical Center, Laura Schwarz-Kipp Research of Autoimmune Diseases, Sackler School of Medicine Tel-Aviv University, Ramat-Gann, Israel. anat.achiron@sheba.health.gov.il.ORCID http://orcid.org/0000-0002-2020-3126
Mathilda MandelNeuroimmunology Laboratory at the Multiple Sclerosis Center, Sheba Medical Center, Laura Schwarz-Kipp Research of Autoimmune Diseases, Sackler School of Medicine Tel-Aviv University, Ramat-Gann, Israel.
Michael GurevichNeuroimmunology Laboratory at the Multiple Sclerosis Center, Sheba Medical Center, Laura Schwarz-Kipp Research of Autoimmune Diseases, Sackler School of Medicine Tel-Aviv University, Ramat-Gann, Israel.
Sapir Dreyer-AlsterNeuroimmunology Laboratory at the Multiple Sclerosis Center, Sheba Medical Center, Laura Schwarz-Kipp Research of Autoimmune Diseases, Sackler School of Medicine Tel-Aviv University, Ramat-Gann, Israel.
David MagalashviliNeuroimmunology Laboratory at the Multiple Sclerosis Center, Sheba Medical Center, Laura Schwarz-Kipp Research of Autoimmune Diseases, Sackler School of Medicine Tel-Aviv University, Ramat-Gann, Israel.
Polina SonisNeuroimmunology Laboratory at the Multiple Sclerosis Center, Sheba Medical Center, Laura Schwarz-Kipp Research of Autoimmune Diseases, Sackler School of Medicine Tel-Aviv University, Ramat-Gann, Israel.
Mark DolevNeuroimmunology Laboratory at the Multiple Sclerosis Center, Sheba Medical Center, Laura Schwarz-Kipp Research of Autoimmune Diseases, Sackler School of Medicine Tel-Aviv University, Ramat-Gann, Israel.
Shay MenascuNeuroimmunology Laboratory at the Multiple Sclerosis Center, Sheba Medical Center, Laura Schwarz-Kipp Research of Autoimmune Diseases, Sackler School of Medicine Tel-Aviv University, Ramat-Gann, Israel.
Gil HarariNeuroimmunology Laboratory at the Multiple Sclerosis Center, Sheba Medical Center, Laura Schwarz-Kipp Research of Autoimmune Diseases, Sackler School of Medicine Tel-Aviv University, Ramat-Gann, Israel.
Shlomo FlechterNeuroimmunology Laboratory at the Multiple Sclerosis Center, Sheba Medical Center, Laura Schwarz-Kipp Research of Autoimmune Diseases, Sackler School of Medicine Tel-Aviv University, Ramat-Gann, Israel.
Rina FalbNeuroimmunology Laboratory at the Multiple Sclerosis Center, Sheba Medical Center, Laura Schwarz-Kipp Research of Autoimmune Diseases, Sackler School of Medicine Tel-Aviv University, Ramat-Gann, Israel.
Tel Aviv University · IL

Funding

Sheba Multiple Sclerosis Center RA-2801/2020.
6 · The paper itself

Abstract

backgroundThe majority of multiple sclerosis [MS] patients treated with fingolimod fail to develop a protective level of IgG humoral and adaptive cellular immune responses following full BNT162b2 SARS-CoV-2 vaccination.

objectiveTo compare the efficacy of the third COVID-19 vaccine dose in vaccine non-responders fingolimod-treated MS patients. STUDY

designThis is a prospective 3-month, single-center, randomized clinical trial.

methodsTwenty relapsing MS patients who had been on fingolimod therapy ≥ 12 months and failed to develop humoral IgG immune response to 2-dose Pfizer BNT162b2 COVID-19 vaccination were randomized into two groups: fingolimod-continuation group and fingolimod-discontinuation group. Humoral and memory cellular immune responses were assessed within 1 and 3 months following the third Pfizer BNT162b2 vaccine dose and compared between the groups.

resultsA higher rate of patients in the fingolimod-discontinuation group [n = 8/10] compared to fingolimod-continuation group [n = 2/10] developed positive SARS-COV-2 IgG. Median IgG titer 1 month following the third dose was 202.3 BAU/ml vs. 26.4 BAU/ml, respectively, p = 0.022. The development of IgG humoral response correlated with absolute lymphocyte count. Specific SARS-COV-2 memory B cell and T cell immune responses were not detected in both groups, either at 1 month or 3 months following the third COVID-19 vaccine dose.

conclusionsShort period of fingolimod treatment discontinuation was associated with the development of humoral protection but not with adaptive cellular immunity.

Indexed as

COVID-19Multiple SclerosisAntibodies, ViralBNT162 VaccineCOVID-19 VaccinesFingolimod HydrochlorideHumansImmunityImmunoglobulin GLymphocyte CountProspective StudiesSARS-CoV-2Antibodies, ViralBNT162 VaccineCOVID-19 VaccinesFingolimod HydrochlorideImmunoglobulin GCellular immunityCOVID-19FingolimodHumoral immunityIgG antibodyMultiple sclerosisThird BNT162b2 SARS-CoV-2 vaccine dose

Identifiers

PMID35235002
PMCPMC8889521
OpenAlexW4214879309

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.