Phase 1 Evaluation of H1 Influenza Vaccine Delivered by MIMIX MAP

Phase 1

Completed

• Conditions: Influenza
• Interventions: Biological: H1 influenza antigen

• Registration Number: NCT06125717
• Lead Sponsor: Vaxess Technologies

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-02
• Primary Completion: 2023-03-13
• Study Completion: 2023-03-13
• Study First Submitted: 2023-10-30
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-03
• Last Update Submitted: 2023-11-03
• Study First Posted: 2023-11-09
• Last Update Posted: 2023-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
15 μg of the H1 influenza antigen	H1 influenza antigen	-
7.5 μg of the H1 influenza antigen	H1 influenza antigen	-
Placebo (no antigen)	H1 influenza antigen	-

Primary Outcome Measures

Name	Time	Method
To determine the safety of VX-103 delivered as a single MIMIX MAP immunization	180 Days

Trial Locations

Locations (3)

Centricity Research Mirabel; 🇨🇦 Mirabel, Quebec, Canada

Centricity Research Toronto; 🇨🇦 Toronto, Ontario, Canada

Centricity Research Pointe-Claire; 🇨🇦 Pointe-Claire, Quebec, Canada