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NCT06067555 · ClinicalTrials.gov registry record · Early Phase 1
Intradermal Influenza Vaccination
A Early Phase 1 study of Vaccine Reaction, sponsored by Yale University.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 249
- Enrollment target
- 1
- Study location
NCT06067555: Recruiting Early Phase 1 study of Vaccine Reaction, sponsored by Yale University.
NCT06067555 is a Early Phase 1 study of Vaccine Reaction that is actively recruiting participants, run by Yale University. The registered enrollment target is 249 participants, above the 81-participant average among 4 other Vaccine Reaction trials with a reported enrollment target (207% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06067555, a Early Phase 1 study of Vaccine Reaction, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 249 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this study is to characterize the immune response, both innate and adaptive, as well as locally and systemic, to intradermal (ID) vaccination in healthy individuals. The intervention involves intradermal administration of an FDA-approved intramuscular seasonal influenza vaccine, using an FDA-approved device MicronJet. Investigators will measure antibody titers, cell subtypes, and multi-omic profiles, by collecting skin and peripheral blood at baseline and at several time points after vaccination. The primary objective is to identify baseline correlates of immune response in the skin and peripheral blood to the seasonal influenza vaccine. The investigators secondary goals are to describe the inflammatory response in the skin over time.
Primary Outcome
Change in antibody titer to vaccination as measured by microneutralization titers at day 0 and day 28 will be correlated with biomarkers in the blood using generalized estimating equations.
Conditions Studied
Interventions
- DEVICE MicronJet
- BIOLOGICAL Fluzone® Quadrivalent
- OTHER Bacteriostatic Saline
Study Locations (1)
Connecticut
- Church Street Research Unit - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 249 participants |
| Start Date | 2024-01-24 |
| Est. Completion | 2026-05 |
| Phase | Early Phase 1 |
What NCT06067555 shows while recruiting
NCT06067555 is an interventional study that assigns participants to a tested intervention. The registered 249 participants enrollment target is mid-sized for trials with a published cap, above the 81-participant average among 4 other Vaccine Reaction trials with a reported enrollment target (207% higher).
The record links to 1 condition, with Vaccine Reaction appearing as the primary indexed condition, and to 3 interventions - of which MicronJet is the first listed.
NCT06067555 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT06067555 about?
NCT06067555 is a clinical study titled "Intradermal Influenza Vaccination". The goal of this study is to characterize the immune response, both innate and adaptive, as well as locally and systemic, to intradermal (ID) vaccination in healthy individuals. The intervention involves intradermal administration of an FDA-approved intramuscular seasonal influenza vaccine, using an...
What is the current status of trial NCT06067555?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 249 participants. The study started on 2024-01-24. Estimated completion is 2026-05.
What conditions does trial NCT06067555 study?
This clinical trial studies the following conditions: Vaccine Reaction.
What interventions are being tested in trial NCT06067555?
The interventions under investigation include: MicronJet (DEVICE), Fluzone® Quadrivalent (BIOLOGICAL), Bacteriostatic Saline (OTHER).
Who is sponsoring clinical trial NCT06067555?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06067555 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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