NCT06125717

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2022

Shorter than P25 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

8 months

First QC Date

October 30, 2023

Last Update Submit

November 3, 2023

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

  • To determine the safety of VX-103 delivered as a single MIMIX MAP immunization

    180 Days

Study Arms (3)

15 μg of the H1 influenza antigen

ACTIVE COMPARATOR
Biological: H1 influenza antigen

7.5 μg of the H1 influenza antigen

ACTIVE COMPARATOR
Biological: H1 influenza antigen

Placebo (no antigen)

PLACEBO COMPARATOR
Biological: H1 influenza antigen

Interventions

H1 influenza antigenBIOLOGICAL

Either 7.5 μg or 15 μg of the H1 influenza antigen

15 μg of the H1 influenza antigen7.5 μg of the H1 influenza antigenPlacebo (no antigen)

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centricity Research Toronto

Toronto, Ontario, M9W 4L6, Canada

Location

Centricity Research Mirabel

Mirabel, Quebec, J7J 2K8, Canada

Location

Centricity Research Pointe-Claire

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

Related Publications (1)

  • Garg N, Tellier G, Vale N, Kluge J, Portman JL, Markowska A, Tussey L. Phase 1, randomized, rater and participant blinded placebo-controlled study of the safety, reactogenicity, tolerability and immunogenicity of H1N1 influenza vaccine delivered by VX-103 (a MIMIX microneedle patch [MAP] system) in healthy adults. PLoS One. 2024 Jun 6;19(6):e0303450. doi: 10.1371/journal.pone.0303450. eCollection 2024.

    PMID: 38843267DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2023

First Posted

November 9, 2023

Study Start

July 2, 2022

Primary Completion

March 13, 2023

Study Completion

March 13, 2023

Last Updated

November 9, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(3)