NCT06612515

Brief Summary

Managing respiratory virus infections in immunocompromised patients requires a multidisciplinary approach, including vaccination, though its effectiveness is often suboptimal in these individuals. In hematological patients, poor humoral immunogenicity is common, especially when the B cell axis is affected by disease or treatment, while T cell responses may offer better protection. Current immunologic data on these patients is limited, focusing mostly on serologic parameters. To address this, we will conduct an observational study analyzing early and late booster vaccinations, with a focus on virus-specific T cell responses in vaccinated patients.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Mar 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Mar 2025Dec 2029

First Submitted

Initial submission to the registry

September 19, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 25, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

March 25, 2025

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2029

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

4.1 years

First QC Date

September 19, 2024

Last Update Submit

April 28, 2026

Conditions

Immunodeficiency

Keywords

vaccine; Immunocompromised; immune response

Outcome Measures

Primary Outcomes (1)

  • Humoral immune response after vaccination

    To compare antibody titres between different subgroups of immunocompromised patients after vaccination against respiratory virus infections

    12 months

Secondary Outcomes (2)

  • Cellular immune response after vaccination

    12 months

  • Seroconversion

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Immunocompromised patients vaccinated against respiratory virus infections or willing to be vaccinated

You may qualify if:

  • Signed informed consent form
  • Patients with immunosuppression either by treatment or underlying diseases
  • Patients who are vaccinated or willing to be vaccinated against respiratory virus infections in ac-cordance with current recommendations
  • Age of 18 years or older

You may not qualify if:

  • Patients unwilling/ineligible for vaccination under current recommendations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

EDTA and Serum blood samples

MeSH Terms

Conditions

Immunologic Deficiency Syndromes

Condition Hierarchy (Ancestors)

Immune System Diseases

Central Study Contacts

Sibylle Mellinghoff, MD

CONTACT

+4947885523sibylle.mellinghoff@uk-koeln.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Board certified medical doctor

Study Record Dates

First Submitted

September 19, 2024

First Posted

September 25, 2024

Study Start

March 25, 2025

Primary Completion (Estimated)

April 30, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations

DE(1)