Safety and Immunogenicity of the Bris10 M2SR and Sing2016 M2SR H3N2 Monovalent Influenza Vaccines

NCT03999554 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: FLUGEN-H3N2-V003
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 4

Brief Summary

This is a Phase I double-blind, randomized, placebo-controlled study in 250 healthy adults, 18-49 years of age, inclusive, who are in good health and meet all eligibility criteria. The purpose of this dose escalation clinical study is to assess the safety, tolerability/reactogenicity, and immunogenicity of H3N2 M2SR investigational vaccines for prevention of influenza, when delivered at higher dosages or in two doses . Eligible subjects will be screened and randomized to receive two administrations 28 days apart of Sing2016 M2SR at three dose levels (low, medium, high), Bris10 M2SR at one dose level (low), or placebo in a 1:1:1:1:1 ratio. Study duration will be approximately 8 months with subject participation duration approximately 7 months. The primary study objective is to assess the safety and reactogenicity of a monovalent live single replication influenza H3N2 M2SR vaccine.

Conditions

Influenza A

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Local and Systemic Adverse Events (AEs) Through 29 Days Post-vaccination With Bris10 M2SR and Cumulatively Through Day 209

  Record adverse events following one and two administrations of the Bris10 M2SR influenza vaccine to determine the number and percentage of study participants who experience any vaccine associated adverse events (AEs) or serious adverse events (SAEs) after Bris10 M2SR or placebo administration.

  From baseline through study completion (Day 209)

• Number of Participants With Local and Systemic Adverse Events (AEs) Through 29 Days Post-vaccination With Sing2016 M2SR and Cumulatively Through Day 209

  Record adverse events following one and two administrations of the Sing2016 M2SR influenza vaccine to determine the number and percentage of study participants who experience any vaccine associated adverse events (AEs) or serious adverse events (SAEs) after Sing2016 M2SR or placebo administration.

  From baseline through study completion (Day 209)

Secondary Outcomes (8)

• Percentage of Bris10 M2SR Subjects Demonstrating Seroconversion to Vaccine HA

  From baseline through 28 days post-dose 1 (Day 29)

• Percentage of Sing2016 M2SR Subjects Demonstrating Seroconversion to Vaccine HA

  From baseline through 28 days post-dose 1 (Day 29)

• Percentage of Bris10 M2SR Subjects Demonstrating Seroconversion to Vaccine HA

  From baseline through 28 days post-dose 2 (Day 57)

• Percentage of Sing2016 M2SR Subjects Demonstrating Seroconversion to Vaccine HA

  From baseline through 28 days post-dose 2 (Day 57)

• Percentage of Bris10 M2SR Subjects Demonstrating Mucosal Responses to Vaccine HA

  From baseline through 28 days post-dose 1 (Day 29)

Study Arms (5)

Low dose Sing2016 M2SR

EXPERIMENTAL

Low dose Sing2016 M2SR will be administered intranasally on days 1 and 29

Biological: LD Sing2016 M2SR H3N2 influenza vaccine

Medium dose Sing2016 M2SR

EXPERIMENTAL

Medium dose Sing2016 M2SR will be administered intranasally on days 1 and 29

Biological: MD Sing2016 M2SR H3N2 influenza vaccine

High dose Sing2016 M2SR

EXPERIMENTAL

High dose Sing2016 M2SR will be administered intranasally on days 1 and 29

Biological: HD Sing2016 M2SR H3N2 influenza vaccine

Low dose Bris10 M2SR

ACTIVE COMPARATOR

Low dose Bris10 M2SR will be administered intranasally on days 1 and 29

Biological: LD Bris10 M2SR H3N2 influenza vaccine

Placebo

PLACEBO COMPARATOR

Saline will be administered intranasally on days 1 and 29

Other: Placebo

Interventions

LD Sing2016 M2SR H3N2 influenza vaccine BIOLOGICAL

This group will receive a low dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.

Low dose Sing2016 M2SR

MD Sing2016 M2SR H3N2 influenza vaccine BIOLOGICAL

This group will receive a medium dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.

Medium dose Sing2016 M2SR

HD Sing2016 M2SR H3N2 influenza vaccine BIOLOGICAL

This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.

High dose Sing2016 M2SR

LD Bris10 M2SR H3N2 influenza vaccine BIOLOGICAL

This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally.

Low dose Bris10 M2SR

Placebo OTHER

This group will receive saline placebo administered intranasally.

Placebo

Eligibility Criteria

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

You may qualify if:

• Give written informed consent to participate.
• Age 18 - 49 years old.
• Judged suitable by the PI, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations.
• Willing to use oral, implantable, transdermal or injectable contraceptives, or sexual abstinence, from screening and until 28 days after second vaccine dose.
• Willing to adhere to the requirements of the study and willing and able to communicate with the Investigator and understand the requirements of the study.

You may not qualify if:

• Abnormal screening hematology or chemistry value per the FDA Toxicity Guidance.
• Pulse rate or blood pressure outside the reference range for this study population and considered as clinically significant by the Investigator.
• Has an acute or chronic medical condition or history of a medical condition that, in the opinion of the Investigator, would render the study procedures unsafe or would interfere with the evaluation of the responses.
• Presence or clinically significant history of lung disease, asthma, chronic obstructive pulmonary disease (COPD), or otherwise poor lung function.
• Any confirmed or suspected immunosuppressive or immunodeficient state.
• Presence of household member or close personal or professional (i.e., healthcare worker) who is a child under one year of age; is pregnant; has known immunodeficiency or is receiving immunosuppressant medication; is undergoing or soon to undergo cancer chemotherapy; has been diagnosed with emphysema, COPD, or other severe lung disease and resides in a nursing home; and/or has received a bone marrow or solid organ transplant.
• Females who are pregnant or lactating.
• Acute febrile illness within 72 hours prior to vaccination.
• Any condition, in the opinion of the Investigator, (such as subjects who have medically high-risk conditions) that might interfere with the primary study objectives for safety of the study subject.

Sponsors & Collaborators

• FluGen Inc: lead

Study Sites (4)

RCA

Hollywood, Florida, 33024, United States

Location

JCCT

Lenexa, Kansas, 66219, United States

Location

AMR Lexington

Lexington, Kentucky, 40509, United States

Location

AMR Norfolk

Norfolk, Virginia, 23507, United States

Location

Related Publications (1)

• Eiden J, Fierro C, Schwartz H, Adams M, Ellis KJ, Aitchison R, Herber R, Hatta Y, Marshall D, Moser MJ, Belshe R, Greenberg H, Coelingh K, Kawaoka Y, Neumann G, Bilsel P. Intranasal M2SR (M2-Deficient Single Replication) H3N2 Influenza Vaccine Provides Enhanced Mucosal and Serum Antibodies in Adults. J Infect Dis. 2022 Dec 28;227(1):103-112. doi: 10.1093/infdis/jiac433.

  PMID: 36350017 DERIVED

Results Point of Contact

• Title: Pamuk Bilsel, CSO
• Organization: FluGen

pbilsel@flugen.com

6084426562

Study Officials

• Pamuk Bilsel

  FluGen Inc

  STUDY DIRECTOR

• Carlos Fierro, MD

  JCCT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-blind, placebo-controlled Phase 1 study evaluating the safety and immunogenicity of the Bris10 M2SR and Sing2016 M2SR H3N2 influenza vaccines delivered intranasally to healthy adults. Eligible subjects will be screened and randomized to receive two administrations 28 days apart of Sing2016 M2SR at three dose levels, Bris10 M2SR at one dose level, or placebo in a 1:1:1:1:1 ratio.

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 26, 2019
• Study Start: September 3, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: March 4, 2022
• Results First Posted: March 4, 2022

Record last verified: 2021-12

Locations

US (4)