Phase 1 Evaluation of H1 Influenza Vaccine Delivered by MIMIX MAP

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-02

Study Completion Date

2023-03-13

Brief Summary

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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

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Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes