Phase 1 Evaluation of H1 Influenza Vaccine Delivered by MIMIX MAP

• Sponsor: Vaxess Technologies (Industry)
• Overall Status: Completed
• CT.gov ID: NCT06125717
• Collaborator: ICON plc (Industry), Q2 Solutions (Industry), Centricity Research (Other)
• Enrollment: 45
• Locations: 3
• Arms: 3
• Actual Duration (Months): 8.3
• Patients Per Site: 15
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Influenza	Biological: H1 influenza antigen	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Jul 2, 2022
• Actual Primary Completion Date: Mar 13, 2023
• Actual Study Completion Date: Mar 13, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 15 μg of the H1 influenza antigen	Biological: H1 influenza antigen; Either 7.5 μg or 15 μg of the H1 influenza antigen
Active Comparator: 7.5 μg of the H1 influenza antigen	Biological: H1 influenza antigen; Either 7.5 μg or 15 μg of the H1 influenza antigen
Placebo Comparator: Placebo (no antigen)	Biological: H1 influenza antigen; Either 7.5 μg or 15 μg of the H1 influenza antigen

Outcome Measures

Primary Outcome Measures

1. To determine the safety of VX-103 delivered as a single MIMIX MAP immunization [180 Days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 39 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centricity Research Toronto	Toronto	Ontario	Canada	M9W 4L6
2	Centricity Research Mirabel	Mirabel	Quebec	Canada	J7J 2K8
3	Centricity Research Pointe-Claire	Pointe-Claire	Quebec	Canada	H9R 4S3

Sponsors and Collaborators

• Vaxess Technologies
• ICON plc
• Q2 Solutions
• Centricity Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vaxess Technologies
• ClinicalTrials.gov Identifier: NCT06125717
• Other Study ID Numbers: VX-103-01
• First Posted: Nov 9, 2023
• Last Update Posted: Nov 9, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Influenza, Human

Study Results

No Results Posted as of Nov 9, 2023