Safety and Immunogenicity Study of H3N2 M2SR Monovalent Influenza Vaccine in Healthy Volunteers

Phase 1 Clinical Study To Investigate The Safety And Immunogenicity Of The H3N2 (A/Brisbane/10/2007) M2SR Monovalent Influenza Vaccine

The purpose is of this study is to assess the safety and tolerability of three dose levels of H3N2 M2SR influenza vaccine versus placebo delivered intranasally to healthy adult subjects.

Study Overview

• Status: Completed
• Conditions: Flu
• Intervention / Treatment: Biological: the H3N2 M2SR monovalent influenza vaccine; Other: Placebo

Detailed Description

Healthy adult subjects will be screened with the objective to randomize 96 subjects with the lowest levels of H3 hemagglutination inhibition (HAI) titers that meet all inclusion/exclusion criteria and have signed an informed consent. Subjects will be rank ordered from low to high based on their HAI titer. Subjects will then be assigned treatment based on a randomization to either active vaccine or placebo. The first two subjects dosed in each dose cohort will serve as sentinels and will receive active IP (not randomized).

Subjects will receive a single dose inoculation of the H3N2 M2SR seasonal monovalent influenza vaccine administered intranasally as a liquid formulation, or placebo (saline). The sentinel subjects will be vaccinated in dose cohort 1 and a safety monitoring committee (SMC) will conduct a review of safety data, tolerability, reactogenicity, and clearance of infectious virus prior to dosing the remaining subjects of the cohort with active or placebo.

After the last subject in the cohort has been followed for at least 7 days the SMC will conduct another review of safety data prior to proceeding to the next higher dose level: Cohort 2. The same processes of sentinel subject dosing and SMC review will be conducted for Cohorts 2 and 3.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • JCCT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• Individuals who are in good health at the time of entry into the study as determined by medical history, physical examination, vital signs, and clinical safety laboratory values and clinical judgement of the Principal Investigator (PI)
• The subject signs and dates a written, informed consent form and any required privacy authorization
• Willing to use a reliable form of contraception approved by the Investigator (e.g., intrauterine device [IUD], female condom, diaphragm with spermicide, cervical cap, use of condom by the sexual partner or a sterile sexual partner) for 1 month prior to vaccination and until 28 days following the last visit
• Individuals who are willing and able to communicate with the Investigator and understand the requirements of the study
• Individuals who can comply with trial procedures and are available for the duration of follow-up

Key Exclusion Criteria:

• Any subject with the following screening lab values (per the Food and Drug Association (FDA) Guidance: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials):

  1. Any ≥ Grade 2 abnormality
  2. Clinically significant Grade 1 abnormality as judged by the Principal Investigator or
  3. Clinically non-significant Grade 1 abnormality as judged by the Principal Investigator which, upon repeat testing becomes more abnormal
• History or clinical manifestation of clinically significant health conditions including but not limited to: mental illness, active hematological, renal, hepatic, pulmonary, central nervous, neurological, cardiovascular, endocrine (including diabetes mellitus) or gastrointestinal disorders
• Acute febrile illness within 72 hours prior to vaccination, defined as the presence of a moderate or severe illness with or without fever (as determined by the Investigator through medical history and physical examination), or presence of a fever >38ºC orally.
• Any confirmed or suspected immunosuppressive or immunodeficient state including: asplenia, recurrent severe infections and chronic (more than 14 days) immunosuppressant medication
• Living in the same household with any person with a non-functional or suppressed immune system

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: H3N2 M2SR monovalent influenza vaccine; This group will receive a low, medium or high dose of the H3N2 M2SR monovalent influenza vaccine administered intranasally. It will be compared with placebo in a 3:1 ratio.	Biological: the H3N2 M2SR monovalent influenza vaccine; The H3N2 Bris10 M2SR influenza vaccine candidate (Bris10 M2SR) is formulated to contain different levels of an M2-deleted non-replicating influenza virus expressing the HA and NA genes of influenza strain A/Brisbane/10/2007.
Experimental: placebo; This group will receive saline administered intranasally.	Other: Placebo; saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and severity of local and systemic adverse events (AEs) through 28 days vaccination and cumulatively through Day 180	Record adverse events	from baseline through study completion (Day 180)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects demonstrating seroconversion to vaccine hemagglutinin antigen and the magnitude of the immune response	Test antibodies pre and post vaccination	from baseline through study completion (Day 180)
Length of time that vaccine virus shedding is detected	Test nasal swabs for virus	at 24, 48 and 72 hours post-vaccination and on day 7 post vaccination

Collaborators and Investigators

• Sponsor: FluGen Inc
• Investigators: Study Director: Renee Herber, FluGen Inc; Principal Investigator: Carlos Fierro, MD, Johnson County Clin Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: June 27, 2016
• First Submitted That Met QC Criteria: June 29, 2016
• First Posted (Estimate): July 4, 2016

Study Record Updates

• Last Update Posted (Actual): August 10, 2020
• Last Update Submitted That Met QC Criteria: August 7, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: H3N2-V001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Publications and post to site