Two Doses of Multimeric-001 (M-001) Followed by Influenza Vaccine
Condition: Influenza; Influenza Immunisation
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II randomized, double-blind, placebo-controlled trial in 120 males and
      non-pregnant females, 18 to 49 years old, inclusive, who are in good health and meet all
      eligibility criteria. This clinical trial will be conducted at 3 United States sites and is
      designed to assess the safety, reactogenicity, and immunogenicity of two priming doses of
      M-001 followed by a seasonal quadrivalent inactivated influenza vaccine (IIV4). The duration
      of this trial for each subject will be approximately 7 months. The entire study duration will
      be approximately 24 months. The primary objectives are: 1) To assess the safety as measured
      by vaccine related adverse events, reactogenicity, and laboratory adverse events of two doses
      of M-001 vaccine, each dose administered approximately 21 days apart; and 2) To assess the T
      cell responses to M-001 component peptides following two doses of M-001.
    

Detailed description: 
      This is a Phase II randomized, double-blind, placebo-controlled trial in 120 males and
      non-pregnant females, 18 to 49 years old, inclusive, who are in good health and meet all
      eligibility criteria. This clinical trial will be conducted at 3 United States sites and is
      designed to assess the safety, reactogenicity, and immunogenicity of two priming doses of
      M-001 followed by a seasonal quadrivalent inactivated influenza vaccine (IIV4). The duration
      of this trial for each subject will be approximately 7 months. The entire study duration will
      be approximately 24 months. The primary objectives are: 1) To assess the safety as measured
      by vaccine related adverse events, reactogenicity, and laboratory adverse events of two doses
      of M-001 vaccine, each dose administered approximately 21 days apart; and 2) To assess the T
      cell responses to M-001 component peptides following two doses of M-001. The secondary
      objectives are: 1) To assess all serious adverse events (SAEs) following receipt of each dose
      of M-001 vaccine or placebo, each dose separated by approximately 21 days, through the end of
      the study; 2) To assess all unsolicited non-serious AEs following receipt of each dose of
      M-001 or placebo, each dose separated by approximately 21 days, through 21 days after each
      dose of M-001 or placebo; and 3) To assess the serum HAI and Neut antibody responses to the
      2018-2019 IIV4 vaccine viruses.
    

Intervention name(s): Influenza Multimeric-001 Vaccine; Placebo; Quadrivalent Recombinant Seasonal Influenza Vaccine
Intervention type(s): Biological; Other; Biological
Intervention description(s): The M-001 vaccine consists of 3 repetitions of 9 conserved linear epitopes that are prepared as a single recombinant protein. The M-001 vaccine is expected to protect against existing as well as future seasonal and pandemic virus strains.; Placebo is saline injection; Quadrivalent Inactivated Influenza Vaccine (IIV4) for intramuscular injection is indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Immunogenicity; Influenza Vaccine; M-001 vaccine; Reactogenicity; Safety