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

NCT03999554 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2022-03-04

Study results available
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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

Interventions

BIOLOGICAL

LD Sing2016 M2SR H3N2 influenza vaccine

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

BIOLOGICAL

MD Sing2016 M2SR H3N2 influenza vaccine

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

BIOLOGICAL

HD Sing2016 M2SR H3N2 influenza vaccine

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

BIOLOGICAL

LD Bris10 M2SR H3N2 influenza vaccine

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

OTHER

Placebo

This group will receive saline placebo administered intranasally.

Sponsors & Collaborators

  • FluGen Inc

    lead INDUSTRY

Principal Investigators

  • Pamuk Bilsel · FluGen Inc

  • Carlos Fierro, MD · JCCT

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-03
Primary Completion
2020-07-01
Completion
2020-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03999554 on ClinicalTrials.gov