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Cancer Vaccine

Intradermal Flu Vaccine for Vaccine Reaction

Phase < 1
Recruiting
Led By Andrew Johnston
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 and day 28
Awards & highlights

Study Summary

This trial aims to study how the body's immune system responds to an FDA-approved seasonal influenza vaccine given through the skin. It looks at antibodies, cells, and other features in skin and blood samples.

Who is the study for?
Healthy individuals who can consent, follow study procedures, and are in good general health as per medical history. Excluded are pregnant women or those planning pregnancy, people with certain abnormal lab results, HIV/hepatitis infections, recent vaccines or blood products, surgery or severe infections within specific time frames, immunodeficiencies, other trial enrollments without PI approval, severe vaccine reactions history.Check my eligibility
What is being tested?
The study tests the immune response to an FDA-approved seasonal flu shot given intradermally using MicronJet. It measures how the body's defense system reacts both at the skin level and in the blood after vaccination by checking antibody levels and various cell types over time.See study design
What are the potential side effects?
Potential side effects may include local skin reactions like redness and swelling at the injection site. There could also be systemic responses such as mild fever or muscle aches typical of vaccinations but specifics will depend on individual immune responses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 and day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 and day 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in antibody titer concentration to vaccination-Blood
Change in antibody titer concentration to vaccination-Skin
Secondary outcome measures
Change in antibody titer concentration to vaccination

Trial Design

9Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: ID-6hourExperimental Treatment2 Interventions
Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 6 hours after vaccine administration.
Group II: ID-3dayExperimental Treatment2 Interventions
Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 3 days after vaccine administration.
Group III: ID-2hourExperimental Treatment2 Interventions
Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 2 hours after vaccine administration.
Group IV: ID-28dayExperimental Treatment2 Interventions
Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 3 days after vaccine administration.
Group V: ID-1dayExperimental Treatment2 Interventions
Participants receive intradermal flu vaccination in the upper arm and will have skin biopsy of vaccination site 1 day after vaccine administration.
Group VI: Intramuscular (IM) ControlActive Control1 Intervention
An intramuscular control group, from which no skin biopsies will be taken after vaccination. Only the intramuscular cohort will receive the flu vaccine via standard IM route in the deltoid region of the upper arm.
Group VII: Sal-1hourPlacebo Group2 Interventions
A control group in which bacteriostatic saline is injected intradermally in lieu of influenza vaccine. A skin biopsy will be taken from the "vaccination" site 1 day after administration.
Group VIII: Sal-2hourPlacebo Group2 Interventions
A control group in which bacteriostatic saline is injected intradermally in lieu of influenza vaccine. A skin biopsy will be taken from the "vaccination" site 2 hours after administration.
Group IX: Sal-6hourPlacebo Group2 Interventions
A control group in which bacteriostatic saline is injected intradermally in lieu of influenza vaccine. A skin biopsy will be taken from the "vaccination" site 6 hours after administration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MicronJet
2007
Completed Early Phase 1
~70
Fluzone® Quadrivalent
2014
Completed Phase 3
~2440

Find a Location

Who is running the clinical trial?

Chan Zuckerberg Initiative GrantUNKNOWN
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,601 Total Patients Enrolled
1 Trials studying Vaccine Reaction
480 Patients Enrolled for Vaccine Reaction
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
484 Previous Clinical Trials
1,086,596 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this clinical experiment still open?

"The information posted on clinicaltrials.gov suggests that this medical trial has closed recruitment and is not currently taking applications from potential patients. Originally published in November of 2023, the study was last updated on September 27th of the same year. Nonetheless, 19 other studies are still recruiting participants at this time."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Intradermal Influenza Vaccination
2024. "Intradermal Influenza Vaccination". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06067555.
All > Influenza
~166 spots leftby May 2026
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