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139 Participants NeededMy employer runs this trial

Intradermal Flu Vaccine for Immune Response

AJ
Overseen ByAndrew Johnston, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Yale University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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. 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.

Who Is on the Research Team?

AJ

Andrew Johnston

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults who are eligible to receive the seasonal flu vaccine and do not have conditions or allergies that would prevent safe vaccination. Participants should be generally healthy without immune system problems.

Inclusion Criteria

Healthy Arm: Willingness to comply with all study procedures and availability for the duration of the study, with deidentified samples and data stored for future research
Healthy Arm: Able to proficiently speak, read, and write English
PAIS Arm: Willingness to comply with all study procedures and availability for the duration of the study, with deidentified samples and data stored for future research
See 11 more

Exclusion Criteria

Healthy Arm: Current alcohol use disorders within past 30 days
I have received chemotherapy for cancer in the past 2 years.
Healthy Arm: History of bleeding disorder
See 52 more

What Are the Treatments Tested in This Trial?

Interventions

  • Fluzone® High Dose Quadrivalent
  • Fluzone® Quadrivalent
  • MicronJet

Trial Overview

Researchers are testing how the body responds when a standard flu shot (Fluzone Quadrivalent, including high dose) is given just under the skin using a special device called MicronJet, instead of into the muscle as usual.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Post acute infection syndrome (PAIS) (Exploratory Arm)Experimental Treatment3 Interventions
Group II: Cancer (Exploratory Arm)Experimental Treatment3 Interventions
Group III: HealthyActive Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

Chan Zuckerberg Initiative

Collaborator

Trials
5
Recruited
1,900+

Silicon Valley Community Foundation

Collaborator

Trials
6
Recruited
1,300+

Yale Development Award

Collaborator

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