Immunity to Infection in Healthy Participants and Participants With Cancer

NCT ID: NCT05787964

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-09-01

Brief Summary

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).

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.

Conditions

Influenza; SARS-CoV-2; Hematologic Malignancy; Solid Tumor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy participants

Healthy adults aged \> 18 years

Biological sample collection

Intervention Type: PROCEDURE

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.

Biological sample collection

Intervention Type: PROCEDURE

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.

Biological sample collection

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claudia Lengerke, Ph.D.

Role: STUDY_DIRECTOR

University Hospital Tübingen

Florian Wimmers, Ph.D.

Role: STUDY_DIRECTOR

University Hospital Tuebingen

Locations

University Hopsital Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

SYS01

Identifier Type: -

Identifier Source: org_study_id