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

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ClinicalTrials.gov Identifier: NCT03999554
Recruitment Status : Not yet recruiting
First Posted : June 26, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
FluGen Inc

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.

Condition or disease Intervention/treatment Phase
Influenza A Biological: LD Sing2016 M2SR H3N2 influenza vaccine Biological: MD Sing2016 M2SR H3N2 influenza vaccine Biological: HD Sing2016 M2SR H3N2 influenza vaccine Biological: LD Bris10 M2SR H3N2 influenza vaccine Other: Placebo Phase 1

Detailed Description:
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. This dose escalation clinical study is designed to assess the safety, tolerability/reactogenicity, and immunogenicity of H3N2 M2SR investigational vaccines for prevention of influenza, when delivered at increasing dosages or in two doses. Subjects will be enrolled in five groups in a 1:1:1:1:1 ratio. Arm 1 will receive a low dose of Sing2016 M2SR intranasally on days 1 and 29. Arm 2 will receive a medium dose of Sing2016 M2SR intranasally on days 1 and 29. Arm 3 will receive a high dose of Sing2016 M2SR intranasally on days 1 and 29. Arm 4 will receive a low dose of Bris16 M2SR intranasally on days 1 and 29. Arm 5 will receive a placebo intranasally on days 1 and 29. 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. The secondary study objectives are to evaluate systemic and mucosal immune responses induced by H3N2 M2SR vaccination.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Phase 1b Clinical Study to Investigate the Safety and Immunogenicity of the Bris10 (A/Brisbane/10/2007) M2SR and Sing2016 (A/Singapore/INFIMH-16-0019/2016) M2SR H3N2 Monovalent Influenza Vaccines
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Low dose Sing2016 M2SR
Low dose Sing2016 M2SR will be administered intranasally on days 1 and 29
Biological: LD Sing2016 M2SR H3N2 influenza vaccine
This group will receive a low dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.

Experimental: Medium dose Sing2016 M2SR
Medium dose Sing2016 M2SR will be administered intranasally on days 1 and 29
Biological: MD Sing2016 M2SR H3N2 influenza vaccine
This group will receive a medium dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.

Experimental: High dose Sing2016 M2SR
High dose Sing2016 M2SR will be administered intranasally on days 1 and 29
Biological: HD Sing2016 M2SR H3N2 influenza vaccine
This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.

Active Comparator: Low dose Bris10 M2SR
Low dose Bris10 M2SR will be administered intranasally on days 1 and 29
Biological: LD Bris10 M2SR H3N2 influenza vaccine
This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally.

Placebo Comparator: Placebo
Saline will be administered intranasally on days 1 and 29
Other: Placebo
This group will receive saline placebo administered intranasally.




Primary Outcome Measures :
  1. Bris10 - Frequency and severity of local and systemic adverse events (AEs) through 29 days vaccination and cumulatively through Day 209 [ Time Frame: From baseline through study completion (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.

  2. Sing2016 - Frequency and severity of local and systemic adverse events (AEs) through 29 days vaccination and cumulatively through Day 209 [ Time Frame: From baseline through study completion (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.


Secondary Outcome Measures :
  1. Bris10 - Percentage of subjects demonstrating seroconversion to vaccine hemagglutinin antigen and the magnitude of the immune response [ Time Frame: From baseline through study completion (Day 209) ]
    Assess the immunogenicity of one and two administrations of Bris10 M2SR vaccine by measuring the percentage of subjects with and the strength of humoral, mucosal and cellular immune responses to Bris 10 at specified time points.

  2. Sing2016 - Percentage of subjects demonstrating seroconversion to vaccine hemagglutinin antigen and the magnitude of the immune response [ Time Frame: From baseline through study completion (Day 209) ]
    Assess the immunogenicity of one and two administrations of Sing2016 M2SR vaccine by measuring the percentage of subjects with and the strength of humoral, mucosal and cellular immune responses to Sing2016 at specified time points.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Give written informed consent to participate.
  2. Age 18 - 49 years old.
  3. Judged suitable by the PI, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations.
  4. Willing to use oral, implantable, transdermal or injectable contraceptives, or sexual abstinence, from screening and until 28 days after second vaccine dose.
  5. 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.

Exclusion Criteria:

  1. Abnormal screening hematology or chemistry value per the FDA Toxicity Guidance.
  2. Pulse rate or blood pressure outside the reference range for this study population and considered as clinically significant by the Investigator.
  3. 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.
  4. Presence or clinically significant history of lung disease, asthma, chronic obstructive pulmonary disease (COPD), or otherwise poor lung function.
  5. Any confirmed or suspected immunosuppressive or immunodeficient state.
  6. 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.
  7. Females who are pregnant or lactating.
  8. Acute febrile illness within 72 hours prior to vaccination.
  9. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03999554


Contacts
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Contact: Renee Herber 6084426563 rherber@flugen.com

Locations
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United States, Florida
RCA Not yet recruiting
Hollywood, Florida, United States, 33024
Contact: Howard Schwartz, MD         
Principal Investigator: Howard Schwartz, MD         
United States, Kansas
JCCT Not yet recruiting
Lenexa, Kansas, United States, 66219
Contact: Carlos Fierro, MD         
Principal Investigator: Carlos Fierro, MD         
United States, Kentucky
AMR Lexington Not yet recruiting
Lexington, Kentucky, United States, 40509
Contact: Mark Adams, MD         
Principal Investigator: Mark Adams, MD         
United States, Virginia
AMR Norfolk Not yet recruiting
Norfolk, Virginia, United States, 23507
Contact: Kimberly Ellis, DO         
Principal Investigator: Kimberly Ellis, DO         
Sponsors and Collaborators
FluGen Inc
Investigators
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Study Director: Pamuk Bilsel FluGen Inc
Principal Investigator: Howard Schwartz, MD RCA

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Responsible Party: FluGen Inc
ClinicalTrials.gov Identifier: NCT03999554     History of Changes
Other Study ID Numbers: FLUGEN-H3N2-V003
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs