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Vaccine-induced Immunity in Immunocompromised Patients

Study acronym: RESPONSE
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Enrollment reduced: 5000 → 1000 participantsv5
  2. Minor Re-verified, no change to tracked fieldsv4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 1, 2025 to Mar 25, 2025
    v3
  4. Notable Start date: Nov 1, 2024 to Jan 1, 2025v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT06612515
Lead Sponsor University of Cologne
Conditions
(from sponsor)
Immunodeficiency
Related terms Immunologic Deficiency Syndromes
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov