Immunity to Infection in Healthy Participants and Participants With Cancer

Influenza Clinical Trial

— SYS01  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05787964
• Other study ID #: SYS01
• Status: Active, not recruiting
• Start date: October 1, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: April 2024
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms
• Influenza
• SARS-CoV-2
• Solid Tumor

Intervention

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.

Locations

Country	Name	City	State
Germany	University Hopsital Tuebingen	Tuebingen	Baden-Wuerttemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

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