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

NCT02822105 | Completed Phase 1 DMC

• 1 other identifier: H3N2-V001
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Flu

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage of subjects demonstrating seroconversion to vaccine hemagglutinin antigen and the magnitude of the immune response

  from baseline through study completion (Day 180)

• Length of time that vaccine virus shedding is detected

  at 24, 48 and 72 hours post-vaccination and on day 7 post vaccination

Study Arms (2)

H3N2 M2SR monovalent influenza vaccine

EXPERIMENTAL

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

placebo

EXPERIMENTAL

This group will receive saline administered intranasally.

Other: Placebo

Interventions

the H3N2 M2SR monovalent influenza vaccine BIOLOGICAL

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.

H3N2 M2SR monovalent influenza vaccine

Placebo OTHER

saline

placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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):
• Any ≥ Grade 2 abnormality
• Clinically significant Grade 1 abnormality as judged by the Principal Investigator or
• 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

Sponsors & Collaborators

• FluGen Inc: lead

Study Sites (1)

JCCT

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Renee Herber

  FluGen Inc

  STUDY DIRECTOR

• Carlos Fierro, MD

  Johnson County Clin Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: July 4, 2016
• Study Start: June 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: November 1, 2017
• Last Updated: August 10, 2020

Record last verified: 2020-08

Locations

US (1)