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Influenza VaccineFluVaccNCT06738082

Influenza Vaccine Elicited Immune Response in Immunocompromised Patients

An observational study of Influenza Vaccine and Immunocompromised Patients, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to understand how well influenza vaccines work in some individuals with weakened immune systems compared to healthy individuals. Some people, such as those with HIV, multiple sclerosis, certain cancers, or autoimmune conditions, have more severe influenza disease courses due to their medical… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza Vaccine, Immunocompromised Patients
What is being tested?
Influenza vaccine
Type of treatment
Vaccines
How many people
147 participants
Where
1 siteSwitzerland
Study dates
15 Oct 2024to 31 Jan 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Adult (≥ 18 years old) patients with immunocuppression (Patients with B-cell malignancies after CAR-T cell therapy, multiple sclerosis on sphingosin-1 modulator therapy, rheumatological diseases on methotrexate therapy or people living with HIV on antiretroviral therapy) and non-immunocompromised participants as control group.

Who may be able to join

  • ≥ 18 years old
  • 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.

Who cannot join

  • For People Living With HIV: untreated or ≥2 measured viral loads above 50cp/ml in preceding 6 months
  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Universitsy Hospital Bern

    Bern, 3010

Other trials in Switzerland

About this study

This study aims to understand how well influenza vaccines work in some individuals with weakened immune systems compared to healthy individuals. Some people, such as those with HIV, multiple sclerosis, certain cancers, or autoimmune conditions, have more severe influenza disease courses due to their medical treatments. These individuals may also respond less effectively to vaccines. By comparing immune responses to the influenza vaccine in both immunocompromised patients and healthy participants, this study aims to identify patterns in vaccine effectiveness and side effects. The goal is to find better ways to predict vaccine response in vulnerable patients and improve protection against influenza.

Read the detailed description

The study is a single-center, prospective cohort study evaluating influenza vaccine responses in adults with weakened immune systems compared to healthy adults. Immunocompromised participants include individuals with HIV, multiple sclerosis, rheumatological diseases, and B-cell malignancies after CAR-T cell therapy. All participants will receive a standard influenza vaccine, as recommended in Switzerland, with immune response measured through blood tests at specific time points before and after vaccination.

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.

Being tested
Influenza vaccine
Keywords
influenza, immunocompromised, vaccination, vaccine, CAR-T
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Influenza vaccineBiological

    Standard, commercially available, quadrivalent split-vaccine against influenza is given to all study participants.

Study groups in NCT06738082
Study groupRoleWhat they receive
Control GroupNon-immunocompromised controls
Receives: Biological: Influenza vaccine
CAR-T Cell RecipientsPatients with B-cell malignancies receiving anti-CD19 CAR T-cell therapies
Receives: Biological: Influenza vaccine
Rheumatological DisordersPatients with rheumatological disorders on methothrexate treatment
Receives: Biological: Influenza vaccine
People living with HIVPeople living with HIV on successful antiretroviral treatment
Receives: Biological: Influenza vaccine
Multiple SclerosisPatients with multiple sclerosis on treatment with sphingosine-1-phosphate-receptor-agonists
Receives: Biological: Influenza vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Influenza vaccine elicited humoral immune response

    The primary endpoint is the baseline variable adjusted fold-change of influenza HAI titers in immunosuppressed patients versus non-immunocompromised controls. The sum of foldchanges of hemagglutinin inhibition assay (HAI) titers 4-6 weeks after influenza vaccination will be adjusted for age, sex and baseline HAI titers by regression analysis as these three baseline variables are reported to affect influenza vaccine responses.

    Measured: Directly before and 4-6 weeks after Influenza vaccination

Secondary outcomes (9)

  1. Influenza vaccine elicited microneutralisation antibody titers

    Influenza vaccine elicited microneutralisation titers will be compared between immunocompromised and non-immunocompromised participants.

    Measured: Directly before and 4-6 weeks after Influenza vaccination

  2. Seroprotection rate after influenza vaccination

    The investigators will compare the proportion of patients with seroprotective antibody levels (defined as HAI titer ≥1:40) 4-6 weeks after influenza vaccination in healthy controls and immunosuppressed patients. A HAI titer of ≥1:40 is the accepted threshold for seroprotection by the FDA.

    Measured: Directly before and 4-6 weeks after Influenza vaccination

  3. Vaccine specific T-cell response

    The investigators will measure influenza specific CD4+ and CD8+ T-cells before- and 4-6 weeks after influenza vaccination. Influenza specific T-cells will be measured by ELISPOT assays. The investigators will report differences in mean increase of influenza specific CD4+ and CD8+ Tcells between immunosuppressed and healthy controls 4-6 weeks after vaccination.

    Measured: Directly before and 4-6 weeks after Influenza vaccination

  4. Vaccine Reactogenicity

    The investigators will collect participant information on vaccine reactogenicity by questionnaire (attached to the proposal) one week after vaccination. The investigators will report the frequency of moderate and severe reactogenicity-events per patient group and assess correlation with vaccine response by regression analysis.

    Measured: Directly before and 1 week after Influenza vaccination

  5. Baseline Immune Profile

    The investigators will assess the impact of following baseline immunological parameters on the vaccine elicited immune response:

    • total serum antibody concentrations (IgM, IgA, IgG)
    • Baseline IFN-Gamma and IL-2 production upon stimulation (QuantiferonMONITOR ®)
    • Pre-vaccination influenza specific CD4+ and CD8+ T-cells
    • Cellular abundance (per/mcl whole-blood and in %) of 37 immune cell populations measured by high-throughput mass cytometry (CyTOF)
    • mRNA expression measured by bulk mRNA sequencing (Transcriptomics)
    • single cell mRNA expression
    • epigenome configuration

    Measured: Directly before Influenza vaccination (same day)

  6. Change in PBMC gene-expression profiles

    Changes in individual gene expression one week after influenza vaccination measured by bulk mRNA sequencing (Transcriptomics). Reporting of differential gene expression levels and visualisation in heat-maps.

    Measured: Directly before and 1 week after Influenza vaccination

  7. Baseline Prediction Model for Vaccine Response

    Semi-supervised machine learning methods will be applied to develop a model for prediction of influenza vaccine response defined defined by a HAI-Titer fold change ≥ 4. Variables will contain sociodemographic, clinical data and immunologic baseline profiles. Model performance will be evaluated by means of areas under the receiver operating characteristic curve and confusion matrices. The model will be trained, tested and validated by a 70%, 30% and 15% data split respectively.

    Measured: Directly before and 4-6 week after Influenza vaccination

  8. Gene-Expression Updated Prediction Model for Vaccine Response

    A Gene-expression updated model will assess the predictive power of vaccine induced change in gene expression by adding early post-vaccination immunologic profile data to the baseline model data.

    Measured: Directly before , 1 week and 4-6 week after Influenza vaccination

  9. Intestinal microbiome composition of vaccine responders and non-responders

    To assess differently abundant microbiome composition the investigators will collect stool samples for 16s-rDNA sequencing in a subset of patients. The investigators will compare relative abundance of microbial taxa between vaccine-responders and non-responders defined by a HAI-Titer fold change ≥ 4, 4-6 weeks after vaccination.

    Measured: Directly before Influenza vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2024
  2. Study start15 Oct 2024
  3. Primary completion31 Jan 2025
  4. Study completion31 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06738082
Sponsor's protocol ID
DLF Nr: 5752
Other IDs
BASEC-Nr: 2024-01077
Acronym
FluVacc
Status last verified
Mar 2025
First submitted
12 Dec 2024
Last updated
26 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Manuel O, Humar A, Berutto C, Ely L, Giulieri S, Lien D, Meylan PR, Weinkauf J, Pascual M, Nador R, Aubert JD, Kumar D. Low-dose intradermal versus intramuscular trivalent inactivated seasonal influenza vaccine in lung transplant recipients. J Heart Lung Transplant. 2011 Jun;30(6):679-84. doi: 10.1016/j.healun.2011.01.705. Epub 2011 Mar 5.

    PubMed 21377898

  • van de Witte S, Nauta J, Montomoli E, Weckx J. A Phase III randomised trial of the immunogenicity and safety of quadrivalent versus trivalent inactivated subunit influenza vaccine in adult and elderly subjects, assessing both anti-haemagglutinin and virus neutralisation antibody responses. Vaccine. 2018 Sep 25;36(40):6030-6038. doi: 10.1016/j.vaccine.2018.04.043. Epub 2018 Apr 27.

    PubMed 29709447

  • Pepin S, Donazzolo Y, Jambrecina A, Salamand C, Saville M. Safety and immunogenicity of a quadrivalent inactivated influenza vaccine in adults. Vaccine. 2013 Nov 12;31(47):5572-8. doi: 10.1016/j.vaccine.2013.08.069. Epub 2013 Sep 7.

    PubMed 24016810

  • Lindemann M, Witzke O, Lutkes P, Fiedler M, Kreuzfelder E, Philipp T, Roggendorf M, Grosse-Wilde H. ELISpot assay as a sensitive tool to detect cellular immunity following influenza vaccination in kidney transplant recipients. Clin Immunol. 2006 Sep;120(3):342-8. doi: 10.1016/j.clim.2006.03.002. Epub 2006 Apr 21.

    PubMed 16631409

  • Riese P, Trittel S, Akmatov MK, May M, Prokein J, Illig T, Schindler C, Sawitzki B, Elfaki Y, Floess S, Huehn J, Blazejewski AJ, Strowig T, Hernandez-Vargas EA, Geffers R, Zhang B, Li Y, Pessler F, Guzman CA. Distinct immunological and molecular signatures underpinning influenza vaccine responsiveness in the elderly. Nat Commun. 2022 Nov 12;13(1):6894. doi: 10.1038/s41467-022-34487-z.

    PubMed 36371426

  • Ravichandran S, Erra-Diaz F, Karakaslar OE, Marches R, Kenyon-Pesce L, Rossi R, Chaussabel D, Nehar-Belaid D, LaFon DC, Pascual V, Palucka K, Paust S, Nahm MH, Kuchel GA, Banchereau J, Ucar D. Distinct baseline immune characteristics associated with responses to conjugated and unconjugated pneumococcal polysaccharide vaccines in older adults. Nat Immunol. 2024 Feb;25(2):316-329. doi: 10.1038/s41590-023-01717-5. Epub 2024 Jan 5.

    PubMed 38182669

  • 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.

    PubMed 33484237

  • Cheuvart B, Spiessens B, van Heesbeen R, Hung D, Andrade C, Korejwo-Peyramond J, Tavares-Da-Silva F. Harmonizing the collection of solicited adverse events in prophylactic vaccine clinical trials. Expert Rev Vaccines. 2023 Jan-Dec;22(1):849-859. doi: 10.1080/14760584.2023.2262571. Epub 2023 Oct 9.

    PubMed 37750613

  • Reber A, Katz J. Immunological assessment of influenza vaccines and immune correlates of protection. Expert Rev Vaccines. 2013 May;12(5):519-36. doi: 10.1586/erv.13.35.

    PubMed 23659300

  • 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.

    PubMed 26682988

  • 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.

    PubMed 33422377

  • 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.

    PubMed 34202032

  • 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.

    PubMed 32340868

  • 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.

    PubMed 36316475

  • 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.

    PubMed 31589278

Questions about this trial

What is this clinical trial studying?

An observational study of Influenza Vaccine and Immunocompromised Patients, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Influenza vaccine elicited humoral immune response (time frame: Directly before and 4-6 weeks after Influenza vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06738082, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.

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