Immunity to Infection in Healthy Participants and Participants With Cancer (SYS01)

May 8, 2024 updated by: University Hospital Tuebingen

Systems Biology Analysis of Vaccine-induced Immunity to Infectious Diseases in Healthy Participants and Participants With Cancer

Many cancer patients are highly susceptible to infection and respond poorly to vaccination. This observational study will determine molecular and cellular features of immunity to viral pathogens in participants with cancer and compare them to healthy controls. The aim is to identify how antiviral immunity in participants with cancer differs from that in healthy participants to understand why cancer patients are more susceptible to infections. In this context, the investigators will also evaluate immunity to medically indicated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and seasonal influenza vaccine received by study participants during standard care (vaccines are not part of the study).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Cancer and its treatments are associated with dysregulated immune systems, and cancer patients are highly susceptible to infections (e.g., influenza, SARS-CoV-2). Importantly, cancer patients often respond poorly to vaccination. The molecular and cellular mechanisms underlying immune dysregulation and poor immunity in cancer patients are manifold, variable among individual patients/conditions, and poorly understood. An in-depth understanding of these mechanisms is essential to identifying novel strategies to prevent infectious diseases and developing individualized therapies.

In this observational study, the investigators will collect blood samples from 200 participants with hematological and oncological malignancies and healthy participants and analyze the cellular and humoral immune status in the context of SARS-CoV-2 and influenza infection and vaccination within these samples using systems biological tools. Medically indicated vaccination against SARS-CoV-2 and influenza during study participation is allowed.

This study aims to (1) examine the fundamental innate, cellular, and humoral immune responses to pathogens that form the basis of immunological memory and (2) identify molecular and cellular mechanisms responsible for the reduced immune immunity to viral pathogens in participants with cancer.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Wuerttemberg
      • Tuebingen, Baden-Wuerttemberg, Germany, 72076
        • University Hopsital Tuebingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants with cancer will be drawn from the local clinics at the University Hospital Tübingen. Healthy participants will be recruited from university and hospital employees not associated with the study.

Description

Inclusion Criteria:

  • You are aged 18 years or older.
  • You are able to understand and give informed consent.
  • Participants with cancer: you are suffering from cancer
  • Healthy participants: you are a healthy individual.

Exclusion Criteria:

  • You are unable to give informed consent.
  • You have been suffering from an acute infection with fever during the last three days.
  • You have a Hb level of less than 9 g/dl.
  • You have a human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy participants
Healthy adults aged > 18 years
Procedure: Biological sample collection
Whole blood (blood draw/phlebotomy) will be obtained to proceed with immunologic analysis of samples. Collection of biologic samples will occur up to 12 months.
Participants with haematological malignancies
Multiple myeloma patients receiving lenalidomide and smoldering multiple myeloma patients under observation.
Procedure: Biological sample collection
Whole blood (blood draw/phlebotomy) will be obtained to proceed with immunologic analysis of samples. Collection of biologic samples will occur up to 12 months.
Participants with solid tumours
Stage IV non-small cell lung cancer patients treated with checkpoint inhibitor therapy +/- chemotherapy.
Procedure: Biological sample collection
Whole blood (blood draw/phlebotomy) will be obtained to proceed with immunologic analysis of samples. Collection of biologic samples will occur up to 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in immune cell composition
Time Frame: 12 months
Determination of quantitative, phenotypical, and functional differences in immune cells from healthy participants and participants with cancer.
12 months
Differences in molecular immune cell makeup
Time Frame: 12 months
Determination of epigenetic, transcriptional, and proteomic makeup of immune cells from healthy participants and participants with cancer.
12 months
Differences in virus-specific antibody levels
Time Frame: 12 months
Determination of differences in plasma and serum antibody levels between healthy participants and participants with cancer.
12 months
Differences in cytokine levels
Time Frame: 12 months
Determination of differences in plasma and serum cytokine levels between healthy participants and participants with cancer.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Study Director: Claudia Lengerke, Ph.D., University Hospital Tübingen
  • Study Director: Florian Wimmers, Ph.D., University Hospital Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

March 15, 2023

First Posted (Actual)

March 28, 2023

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYS01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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