Clinical trial NCT05787964: Immunity to Infection in Healthy Participants and Participants With Cancer
Official title: Systems Biology Analysis of Vaccine-induced Immunity to Infectious Diseases in Healthy Participants and Participants With Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Influenza
SARS-CoV-2
Hematologic Malignancy
Solid Tumor
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Differences in virus-specific antibody levels
timeFrame: 12 months
measure: Differences in cytokine levels
timeFrame: 12 months
measure: Differences in immune cell composition
timeFrame: 12 months
measure: Differences in molecular immune cell makeup
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hopsital Tuebingen
state: Baden-Wuerttemberg
Study officials:
affiliation: University Hospital Tübingen
name: Claudia Lengerke, Ph.D.
role: STUDY_DIRECTOR
affiliation: University Hospital Tuebingen
name: Florian Wimmers, Ph.D.
role: STUDY_DIRECTOR
References: