Phase 1 Evaluation of H1 Influenza Vaccine Delivered by MIMIX MAP

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06125717
• Other study ID #: VX-103-01
• Status: Completed
• Phase: Phase 1
• Start date: July 2, 2022
• Est. completion date: March 13, 2023

Study information

• Verified date: November 2023
• Source: Vaxess Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 13, 2023
• Est. primary completion date: March 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• H1 influenza antigen
Either 7.5 µg or 15 µg of the H1 influenza antigen

Locations

Country	Name	City	State
Canada	Centricity Research Mirabel	Mirabel	Quebec
Canada	Centricity Research Pointe-Claire	Pointe-Claire	Quebec
Canada	Centricity Research Toronto	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Vaxess Technologies	Centricity Research, ICON plc, Q2 Solutions

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the safety of VX-103 delivered as a single MIMIX MAP immunization		180 Days