- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03999554
Safety and Immunogenicity of the Bris10 M2SR and Sing2016 M2SR H3N2 Monovalent Influenza Vaccines
December 10, 2021 updated by: FluGen Inc
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
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
206
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
-
Hollywood, Florida, United States, 33024
- RCA
-
-
Kansas
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Lenexa, Kansas, United States, 66219
- JCCT
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Kentucky
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Lexington, Kentucky, United States, 40509
- AMR Lexington
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Virginia
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Norfolk, Virginia, United States, 23507
- AMR Norfolk
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 49 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Low dose Sing2016 M2SR
Low dose Sing2016 M2SR will be administered intranasally on days 1 and 29
|
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
|
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
|
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
|
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
|
This group will receive saline placebo administered intranasally.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Local and Systemic Adverse Events (AEs) Through 29 Days Post-vaccination With Bris10 M2SR 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.
|
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
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.
|
From baseline through study completion (Day 209)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Bris10 M2SR Subjects Demonstrating Seroconversion to Vaccine HA
Time Frame: From baseline through 28 days post-dose 1 (Day 29)
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Assess the humoral immunogenicity of one administration of Bris10 M2SR vaccine to Bris 10 by HAI at day 29.
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From baseline through 28 days post-dose 1 (Day 29)
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Percentage of Sing2016 M2SR Subjects Demonstrating Seroconversion to Vaccine HA
Time Frame: From baseline through 28 days post-dose 1 (Day 29)
|
Assess the humoral immunogenicity of one administration of Sing2016 M2SR vaccine to Sing2016 by HAI at day 29
|
From baseline through 28 days post-dose 1 (Day 29)
|
Percentage of Bris10 M2SR Subjects Demonstrating Seroconversion to Vaccine HA
Time Frame: From baseline through 28 days post-dose 2 (Day 57)
|
Assess the humoral immunogenicity of two administrations of Bris10 M2SR vaccine to Bris 10 by HAI at d57.
|
From baseline through 28 days post-dose 2 (Day 57)
|
Percentage of Sing2016 M2SR Subjects Demonstrating Seroconversion to Vaccine HA
Time Frame: From baseline through 28 days post-dose 2 (Day 57)
|
Assess the humoral immunogenicity of two administrations of Sing2016 M2SR vaccine to Sing2016 by HAI at day 57
|
From baseline through 28 days post-dose 2 (Day 57)
|
Percentage of Bris10 M2SR Subjects Demonstrating Mucosal Responses to Vaccine HA
Time Frame: From baseline through 28 days post-dose 1 (Day 29)
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Assess the mucosal immunogenicity of one administration of Bris10 M2SR vaccine to Bris 10 by ELISA at day 29.
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From baseline through 28 days post-dose 1 (Day 29)
|
Percentage of Bris10 M2SR Subjects Demonstrating Mucosal Responses to Vaccine HA
Time Frame: From baseline through 28 days post-dose 2 (Day 57)
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Assess the mucosal immunogenicity of two administrations of Bris10 M2SR vaccine to Bris 10 by ELISA at day 57.
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From baseline through 28 days post-dose 2 (Day 57)
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Percentage of Sing2016 M2SR Subjects Demonstrating Mucosal Responses to Vaccine HA
Time Frame: From baseline through 28 days post-dose 2 (Day 57)
|
Assess the mucosal immunogenicity of two administrations of Sing2016 M2SR vaccine to Sing2016 by ELISA at day 57
|
From baseline through 28 days post-dose 2 (Day 57)
|
Percentage of Sing2016 M2SR Subjects Demonstrating Mucosal Responses to Vaccine HA
Time Frame: From baseline through 28 days post-dose 1 (Day 29)
|
Assess the mucosal immunogenicity of one administration of Sing2016 M2SR vaccine to Sing2016 by ELISA at day 29
|
From baseline through 28 days post-dose 1 (Day 29)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 3, 2019
Primary Completion (ACTUAL)
July 1, 2020
Study Completion (ACTUAL)
July 1, 2020
Study Registration Dates
First Submitted
June 18, 2019
First Submitted That Met QC Criteria
June 25, 2019
First Posted (ACTUAL)
June 26, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 4, 2022
Last Update Submitted That Met QC Criteria
December 10, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FLUGEN-H3N2-V003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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