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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
Must not have
Prior receipt of a current seasonal influenza vaccine (for the season of participation)
Cancer chemotherapy in the past 2 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 and day 28
Awards & highlights

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received this season's flu vaccine.
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I have not had cancer chemotherapy in the last 2 years.
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I have not received a live vaccine in the last 3 months.
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I had surgery within the last 8 weeks or plan to have surgery within the next 28 days.
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I have a history of bleeding disorders.
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I have had Guillain-Barre syndrome in the past.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in antibody titer concentration to vaccination-Blood
Change in antibody titer concentration to vaccination-Skin
Secondary study objectives
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
2,765 Previous Clinical Trials
8,133,262 Total Patients Enrolled
1 Trials studying Vaccine Reaction
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
493 Previous Clinical Trials
1,089,181 Total Patients Enrolled
~166 spots leftby May 2026
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