Clinical trial NCT06125717: Phase 1 Evaluation of H1 Influenza Vaccine Delivered by MIMIX MAP
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza
Lead sponsor: Vaxess Technologies
Sponsor class: INDUSTRY
Collaborators: name: ICON plc
name: Q2 Solutions
name: Centricity Research
First posted: 2023-11-09
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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


Eligibility criteria: 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.

Primary outcomes:
measure: To determine the safety of VX-103 delivered as a single MIMIX MAP immunization
timeFrame: 180 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centricity Research Toronto
state: Ontario
city: Mirabel
country: Canada
facility: Centricity Research Mirabel
state: Quebec
city: Pointe-Claire
country: Canada
facility: Centricity Research Pointe-Claire
state: Quebec
Study officials:
References: