Characterization of Immune Response to Intradermal Influenza Vaccination
Yale University
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.
Description
Subjects will remain on study and may optionally repeat study visits (including vaccination) annually through the 2025-26 influenza season, with final study follow-up up to 1 year after vaccination. Sampling individual subjects across several influenza seasons will allow for monitoring of multi-season responses. Skin, blood, nasal mucosal lining fluid, nasopharyngeal cells, saliva, and skin microbe samples will be collected at various timepoints before and up to 365 days after vaccination to explore short and long-term effects of immunization. Subjects may optionally provide stool samples.
Eligibility
- Age range
- 18–40 years
- Sex
- All
- Healthy volunteers
- Yes
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study, as well as have deidentified samples and data stored for future research. 3. Able to proficiently speak, read, and write English. 4. Male or female, aged 18-40 years old at time of initial enrollment a. Participant is allowed to participate in subsequent influenza seasons even if they will be \>40 years old. 5. In good gene…
Interventions
- DeviceMicronJet
MicronJet 600 syringe will be used to administer intradermal flu vaccine injections
- BiologicalFluzone® Quadrivalent
Intradermal injections of 0.3mL
- BiologicalFluzone® Quadrivalent
Intramuscular injection of 0.3mL
- OtherBacteriostatic Saline
Intradermal injection of 0.3mL (control)
Location
- Church Street Research UnitNew Haven, Connecticut