Safety and Immunogenicity of the Bris10 M2SR and Sing2016 M2SR H3N2 Monovalent Influenza Vaccines
Condition: Influenza A
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

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.
    

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.
    

Intervention name(s): LD Sing2016 M2SR H3N2 influenza vaccine; MD Sing2016 M2SR H3N2 influenza vaccine; HD Sing2016 M2SR H3N2 influenza vaccine; LD Bris10 M2SR H3N2 influenza vaccine; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Other
Intervention description(s): This group will receive a low dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.; This group will receive a medium dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.; This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.; This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally.; This group will receive saline placebo administered intranasally.
Intervention MeSH terms: Vaccines
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)
Primary purpose: Basic Science