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

FluGen

Status and phase: Completed; Phase 1

Conditions: Influenza A

Treatments: Biological: LD Sing2016 M2SR H3N2 influenza vaccine; Biological: HD Sing2016 M2SR H3N2 influenza vaccine; Biological: MD Sing2016 M2SR H3N2 influenza vaccine; Other: Placebo; Biological: LD Bris10 M2SR H3N2 influenza vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03999554

FLUGEN-H3N2-V003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 206 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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206 participants in 5 patient groups, including a placebo group

Low dose Sing2016 M2SR

Experimental group

Description:

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

Treatment:

Biological: LD Sing2016 M2SR H3N2 influenza vaccine

Medium dose Sing2016 M2SR

Experimental group

Description:

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

Treatment:

Biological: MD Sing2016 M2SR H3N2 influenza vaccine

High dose Sing2016 M2SR

Experimental group

Description:

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

Treatment:

Biological: HD Sing2016 M2SR H3N2 influenza vaccine

Low dose Bris10 M2SR

Active Comparator group

Description:

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

Treatment:

Biological: LD Bris10 M2SR H3N2 influenza vaccine

Placebo

Placebo Comparator group

Description:

Saline will be administered intranasally on days 1 and 29

Treatment:

Other: Placebo