Phase 1 Evaluation of H1 Influenza Vaccine Delivered by MIMIX MAP

Study Overview
=================
Brief Summary
-----------------
A Phase 1, Randomized, Rater and Participant Blinded Placebo Controlled Study to Evaluate the Safety, Reactogenicity, Tolerability and Immunogenicity of a Standard and a Fractional Dose of H1 Influenza Vaccine Delivered by VX-103 (a MIMIX Microneedle Array Patch (MAP) System) in Healthy Adults ≥18-39 Years of Age

Official Title
-----------------
A Phase 1, Randomized, Rater and Subject Blinded Placebo Controlled Study to Evaluate the Safety, Reactogenicity, Tolerability and Immunogenicity of a Standard and a Fractional Dose of H1 Influenza Vaccine Delivered by VX-103 (a MIMIX Microneedle Patch (MAP) System) in Healthy Adults ≥18-39 Years of Age

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: H1 influenza antigen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18 - 39 years inclusive Provide written informed consent to participate Healthy participants without acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality o As determined by medical history, physical exam, laboratory screening Body Mass Index 18-35 kg/m2, inclusive, at screening Exclusion Criteria: Any medical condition that in the judgement of the investigator would make subject participation in the study unsafe. Having cancer or received treatment for cancer within three years (persons with a history of cancer who are disease-free without treatment for three years or more are eligible), excluding basal cell carcinoma (BCC) or squamous cell carcinoma (SCC), which are allowed unless located at the vaccination site. Impaired immune responsiveness (of any cause), including diabetes mellitus. Receipt or plan to receive a non-study vaccine within 30 days prior to vaccination or 60 days after vaccination. Receipt of any influenza vaccine in previous 24 months and/or planned receipt of influenza vaccine for the duration of the study. Diagnosed influenza infection in the previous 24 months prior to screening. Diagnosed COVID infection via medical personnel or at home test within the past 60 days prior to screening Allergy to influenza vaccine or components, or history of severe local or systemic reaction to any vaccination. History of anaphylactic type reaction to injected vaccines History of or current allergy to latex History of Guillain-Barré Syndrome. Positive test result for hepatitis B surface antigen (HBsAg,), hepatitis C virus antibody (HBcAb), or human immunodeficiency virus (HIV) types 1 or 2 antibodies at screening. History of chronic obstructive pulmonary disease or history of other lung disease. History of severe allergic reactions to eggs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 7.5 μg of the H1 influenza antigen<br> | Biological: H1 influenza antigen<br>* Either 7.5 μg or 15 μg of the H1 influenza antigen<br>|
| Placebo Comparator: Placebo (no antigen)<br> | Biological: H1 influenza antigen<br>* Either 7.5 μg or 15 μg of the H1 influenza antigen<br>|
| Active Comparator: 15 μg of the H1 influenza antigen<br> | Biological: H1 influenza antigen<br>* Either 7.5 μg or 15 μg of the H1 influenza antigen<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety of VX-103 delivered as a single MIMIX MAP immunization |  | 180 Days |