Influenza Vaccine Elicited Immune Response in Immunocompromised Patients
NCT ID: NCT06738082
Last Updated: 2025-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
147 participants
OBSERVATIONAL
2024-10-15
2025-01-31
Brief Summary
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Detailed Description
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The primary objective is to compare influenza vaccine antibody levels in immunocompromised and healthy participants to determine if immune responses are different in the former group. Secondary objectives include examining vaccine-induced immune cell activity, side effects, and the immune profile before vaccination in each patient subgroup. The study will also analyze gut microbiome differences between responders and non-responders and develop prediction models for vaccine effectiveness based on immune and demographic data. By doing so, researchers hope to enhance the understanding of how best to protect immunocompromised patients against influenza.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Control Group
Non-immunocompromised controls
Influenza vaccine
Standard, commercially available, quadrivalent split-vaccine against influenza is given to all study participants.
CAR-T Cell Recipients
Patients with B-cell malignancies receiving anti-CD19 CAR T-cell therapies
Influenza vaccine
Standard, commercially available, quadrivalent split-vaccine against influenza is given to all study participants.
Rheumatological Disorders
Patients with rheumatological disorders on methothrexate treatment
Influenza vaccine
Standard, commercially available, quadrivalent split-vaccine against influenza is given to all study participants.
People living with HIV
People living with HIV on successful antiretroviral treatment
Influenza vaccine
Standard, commercially available, quadrivalent split-vaccine against influenza is given to all study participants.
Multiple Sclerosis
Patients with multiple sclerosis on treatment with sphingosine-1-phosphate-receptor-agonists
Influenza vaccine
Standard, commercially available, quadrivalent split-vaccine against influenza is given to all study participants.
Interventions
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Influenza vaccine
Standard, commercially available, quadrivalent split-vaccine against influenza is given to all study participants.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with rheumatological diseases on immunosuppressive therapies, or Multiple sclerosis on immune modulating therapies, or B-cell malignancies after CAR-T cell therapy, or o PLWH with CD4 cell count \>200/ul, or Non-immunocompromised individuals attending the University Clinic for Infectious Diseases to receive influenza vaccination.
* Provided written informed consent.
Exclusion Criteria
* For non-immunocompromised controls: any inborn or acquired condition resulting in immunosuppression.
* Receiving B-cell depleting therapies in last 12 Months for MS, RA patients and PLWH
* Receipt of Immunoglobulin-therapy (IVIG) ≤4 months prior to the drawing of study samples
* \< 18 years old
* Lack of written informed consent
18 Years
ALL
Yes
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Christine Thurnheer, PD, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Bern, Switzerland
Cédric Hirzel, PD, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Bern, Switzerland
Locations
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Universitsy Hospital Bern
Bern, , Switzerland
Countries
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References
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Hirzel C, Chruscinski A, Ferreira VH, L'Huillier AG, Natori Y, Han SH, Cordero E, Humar A, Kumar D; Influenza in Transplant Study Group. Natural influenza infection produces a greater diversity of humoral responses than vaccination in immunosuppressed transplant recipients. Am J Transplant. 2021 Aug;21(8):2709-2718. doi: 10.1111/ajt.16503. Epub 2021 Feb 18.
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Nakaya HI, Hagan T, Duraisingham SS, Lee EK, Kwissa M, Rouphael N, Frasca D, Gersten M, Mehta AK, Gaujoux R, Li GM, Gupta S, Ahmed R, Mulligan MJ, Shen-Orr S, Blomberg BB, Subramaniam S, Pulendran B. Systems Analysis of Immunity to Influenza Vaccination across Multiple Years and in Diverse Populations Reveals Shared Molecular Signatures. Immunity. 2015 Dec 15;43(6):1186-98. doi: 10.1016/j.immuni.2015.11.012.
Caldera F, Mercer M, Samson SI, Pitt JM, Hayney MS. Influenza vaccination in immunocompromised populations: Strategies to improve immunogenicity. Vaccine. 2021 Mar 15;39 Suppl 1:A15-A23. doi: 10.1016/j.vaccine.2020.11.037. Epub 2021 Jan 7.
Huang D, Liu AYN, Leung KS, Tang NLS. Direct Measurement of B Lymphocyte Gene Expression Biomarkers in Peripheral Blood Transcriptomics Enables Early Prediction of Vaccine Seroconversion. Genes (Basel). 2021 Jun 25;12(7):971. doi: 10.3390/genes12070971.
Tsang JS, Dobano C, VanDamme P, Moncunill G, Marchant A, Othman RB, Sadarangani M, Koff WC, Kollmann TR. Improving Vaccine-Induced Immunity: Can Baseline Predict Outcome? Trends Immunol. 2020 Jun;41(6):457-465. doi: 10.1016/j.it.2020.04.001. Epub 2020 Apr 8.
Hagan T, Gerritsen B, Tomalin LE, Fourati S, Mule MP, Chawla DG, Rychkov D, Henrich E, Miller HER, Diray-Arce J, Dunn P, Lee A; Human Immunology Project Consortium (HIPC); Levy O, Gottardo R, Sarwal MM, Tsang JS, Suarez-Farinas M, Sekaly RP, Kleinstein SH, Pulendran B. Transcriptional atlas of the human immune response to 13 vaccines reveals a common predictor of vaccine-induced antibody responses. Nat Immunol. 2022 Dec;23(12):1788-1798. doi: 10.1038/s41590-022-01328-6. Epub 2022 Oct 31.
Luna G, Alping P, Burman J, Fink K, Fogdell-Hahn A, Gunnarsson M, Hillert J, Langer-Gould A, Lycke J, Nilsson P, Salzer J, Svenningsson A, Vrethem M, Olsson T, Piehl F, Frisell T. Infection Risks Among Patients With Multiple Sclerosis Treated With Fingolimod, Natalizumab, Rituximab, and Injectable Therapies. JAMA Neurol. 2020 Feb 1;77(2):184-191. doi: 10.1001/jamaneurol.2019.3365.
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Furer V, Rondaan C, Heijstek M, van Assen S, Bijl M, Agmon-Levin N, Breedveld FC, D'Amelio R, Dougados M, Kapetanovic MC, van Laar JM, Ladefoged de Thurah A, Landewe R, Molto A, Muller-Ladner U, Schreiber K, Smolar L, Walker J, Warnatz K, Wulffraat NM, Elkayam O. Incidence and prevalence of vaccine preventable infections in adult patients with autoimmune inflammatory rheumatic diseases (AIIRD): a systemic literature review informing the 2019 update of the EULAR recommendations for vaccination in adult patients with AIIRD. RMD Open. 2019 Sep 19;5(2):e001041. doi: 10.1136/rmdopen-2019-001041. eCollection 2019.
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Related Links
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Word Health Organization. Correlates of vaccine-induced protection: methods and implications. World Health Organization, 2013:
Swiss Federal Office of Public Health (FOPH)
Other Identifiers
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BASEC-Nr: 2024-01077
Identifier Type: OTHER
Identifier Source: secondary_id
DLF Nr: 5752
Identifier Type: -
Identifier Source: org_study_id
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