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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-03

Study Completion Date

2020-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Influenza A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Study Groups

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Low dose Sing2016 M2SR

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

Group Type EXPERIMENTAL

LD Sing2016 M2SR H3N2 influenza vaccine

Intervention Type BIOLOGICAL

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

Medium dose Sing2016 M2SR

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

Group Type EXPERIMENTAL

MD Sing2016 M2SR H3N2 influenza vaccine

Intervention Type BIOLOGICAL

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

High dose Sing2016 M2SR

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

Group Type EXPERIMENTAL

HD Sing2016 M2SR H3N2 influenza vaccine

Intervention Type BIOLOGICAL

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

Low dose Bris10 M2SR

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

Group Type ACTIVE_COMPARATOR

LD Bris10 M2SR H3N2 influenza vaccine

Intervention Type BIOLOGICAL

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

Placebo

Saline will be administered intranasally on days 1 and 29

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

This group will receive saline placebo administered intranasally.

Interventions

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LD Sing2016 M2SR H3N2 influenza vaccine

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

Intervention Type BIOLOGICAL

MD Sing2016 M2SR H3N2 influenza vaccine

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

Intervention Type BIOLOGICAL

HD Sing2016 M2SR H3N2 influenza vaccine

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

Intervention Type BIOLOGICAL

LD Bris10 M2SR H3N2 influenza vaccine

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

Intervention Type BIOLOGICAL

Placebo

This group will receive saline placebo administered intranasally.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes