This is a Phase I randomized, double-blind, controlled trial in 275 males and non-pregnant females, 19 to 64 years old, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of a monovalent inactivated influenza A/H5N8 virus vaccine manufactured by bioCSL administered at different dosages (7.5 or 15 mcg of HA/0.5 mL dose) given with or without AS03 or MF59 adjuvants manufactured by GlaxoSmithKline Biologicals and Novartis Vaccines and Diagnostics, respectively.
This is a Phase I randomized, double-blind, controlled trial in 275 males and non-pregnant females, 19 to 64 years old, inclusive, who are in good health and meet all eligibility criteria which include screening hematology, chemistry and erythrocyte sedimentation rate (ESR) laboratory evaluations. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of a monovalent inactivated influenza A/H5N8 virus vaccine manufactured by bioCSL administered at different dosages (7.5 or 15 mcg of HA/0.5 mL dose) given with or without AS03 or MF59 adjuvants manufactured by GlaxoSmithKline Biologicals and Novartis Vaccines and Diagnostics, respectively. The primary objectives of this study is to assess 1) the safety and reactogenicity of a monovalent inactivated influenza A/H5N8 virus vaccine and 2) the serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody responses to a monovalent inactivated influenza A/H5N8 virus vaccine following receipt of two doses administered intramuscularly at different dosages (7.5 or 15 mcg of HA/0.5 mL dose) given with or without AS03 or MF59 approximately 21 days apart. The secondary objectives of this study are to 1) assess study vaccine-related unsolicited non-serious adverse events following receipt of two doses of a monovalent inactivated influenza A/H5N8 virus vaccine, 2) assess medically attended adverse events (MAAEs) including new-onset chronic medical conditions and immune-mediated or auto-inflammatory adverse events of special interest following receipt of two doses of a monovalent inactivated influenza A/H5N8 virus vaccine, and 3) assess the serum HAI and Neut antibody responses to a monovalent inactivated influenza A/H5N8 virus vaccine following receipt of one dose administered intramuscularly at different dosages (7.5 or 15 mcg of HA/0.5 mL dose) given with or without AS03 or MF59. This study will span approximately 24 months. Subject participation duration will span approximately 13 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
276
AS03 oil-in-water emulsion adjuvant.
Microfluoridized adjuvant 59 (MF59) is an oil-in-water emulsion.
Monovalent inactivated influenza A/H5N8 virus vaccine for IM injection. prepared from influenza virus propagated in chicken egg fluid using seed virus prepared from the candidate vaccine virus (CVV), influenza virus A/gyrfalcon/Washington/41088-6/2014(H5N8)-PR8-IDCDC-RG43A (abbreviated as IDCDC-RG43A).
University of Iowa - Vaccine Research and Education Unit
Iowa City, Iowa, United States
Saint Louis University - Center for Vaccine Development
St Louis, Missouri, United States
Cincinnati Children's Hospital Medical Center - Infectious Diseases
Cincinnati, Ohio, United States
Baylor College of Medicine - Molecular Virology and Microbiology
Houston, Texas, United States
Geometric Mean Titers of serum HAI and Neut antibodies against the A/H5N8 antigen contained in the study vaccine
Time frame: Approximately 21 days after the second study vaccination
Occurrence of clinical safety laboratory adverse events
Time frame: Day 22-30
Occurrence of clinical safety laboratory adverse events
Time frame: Day 1-9
Occurrence of solicited injection site and systemic reactogenicity events
Time frame: Day 1-9
Occurrence of solicited injection site and systemic reactogenicity events
Time frame: Day 22-30
Occurrence of study vaccine-related serious adverse events
Time frame: Day 1-387
Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the A/H5N8 antigen contained in the study vaccine
Time frame: Approximately 21 days after the second study vaccination
Percentage of subjects achieving a serum Neut antibody titer of 1:40 or greater against the A/H5N8 antigen contained in the study vaccine
Time frame: Approximately 21 days after the second study vaccination
Percentage of subjects achieving HAI seroconversion against the A/H5N8 antigen contained in the study vaccine
Time frame: Approximately 21 days after the second study vaccination
Percentage of subjects achieving Neut seroconversion against the A/H5N8 antigen contained in the study vaccine
Time frame: Approximately 21 days after the second study vaccination
Geometric Mean Titers of serum HAI and Neut antibodies against the A/H5N8 antigen contained in the study vaccine
Time frame: At baseline and approximately 8, 21 and 29 days after the first study vaccination
Occurrence of MAAEs including new-onset chronic medical conditions and immune-mediated or auto-inflammatory AESIs
Time frame: Day 1-387
Occurrence of study vaccine-related unsolicited non-serious adverse events after vaccination 1
Time frame: Day 1-22
Occurrence of study vaccine-related unsolicited non-serious adverse events after vaccination 2
Time frame: Day 22-43
Percentage of subjects achieving HAI seroconversion against the A/H5N8 antigen contained in the study vaccine
Time frame: At approximately 8, 21 and 29 days after the first study vaccination
Percentage of subjects achieving Neut seroconversion against the A/H5N8 antigen contained in the study vaccine
Time frame: At approximately 8, 21 and 29 days after the first study vaccination
Percentage of subjects achieving serum HAI and Neut antibody titers of 1:40 or greater against the A/H5N8 antigen contained in the study vaccine
Time frame: At baseline and approximately 8, 21 and 29 days after the first study vaccination
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