This is a Phase II randomized, double-blinded, controlled study in up to 700 males and non-pregnant females, 19 to 64 years old, inclusive, designed to assess the safety, reactogenicity, and immunogenicity of a monovalent influenza A/H7N9 virus vaccine administered at different dosages (3.75, 7.5, or 15 mcg of HA/0.5 mL dose) given with and without MF59 adjuvant and without adjuvant (15 mcg of HA/0.5 mL dose and 45 mcg of HA/0.75 mL dose). Subjects will receive two doses via intramuscular injection, approximately 21 days apart. Safety, reactogenicity, and immunogenicity data will be collected at standard time points with safety follow-up to continue through one year post dose 2. The duration of the study for each subject will be approximately 13 months.
This is a Phase II randomized, double-blinded, controlled study in up to 700 males and non-pregnant females, 19 to 64 years old, inclusive, who are in good health and meet all eligibility criteria. The study is designed to assess the safety, reactogenicity, and immunogenicity of a monovalent influenza A/H7N9 virus vaccine manufactured by Sanofi Pasteur administered to healthy adults at different dosages (3.75, 7.5, or 15 mcg of HA/0.5 mL dose) given with MF59 adjuvant manufactured by Novartis Vaccines and Diagnostics and without adjuvant (15 mcg of HA/0.5 mL dose and 45 mcg of HA/0.75 mL dose). The A/H7N9 vaccine was made with HA antigen derived from the influenza A/Shanghai/2/2013 virus. Subjects will be randomly assigned to 1 of 7 groups (up to 100 subjects per group) to receive two doses of the A/H7N9 vaccine with and without MF59 adjuvant delivered intramuscularly approximately 21 days apart. The same dosage of A/H7N9 vaccine will be given to subjects at both their first and second study vaccinations. The primary objectives are to: 1) assess the safety and reactogenicity of a monovalent influenza A/H7N9 virus vaccine following receipt of two doses administered with and without MF59 adjuvant; and 2) assess new-onset chronic medical conditions following receipt of two doses of a monovalent influenza A/H7N9 virus vaccine administered with and without MF59 adjuvant. The duration of the study for each subject will be approximately 13 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
700
Monovalent influenza A/H7N9 virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension. sanofi A/H7N9 antigen. Group 1 receives 3.75mcg A/H7N9 IM on days 1 and 21, Group 2 receives 7.5 mcg IM on days 1 and 21, Group 3, 4, 5, \& 6 receives 15 mcg IM on days 1 and 21, and Group 7 receives 45 mcg IM on days 1 and 21.
MF59 adjuvant is an oil-in-water emulsion composed of a small amount of squalene administered with different dosages. Group 1, 2 \& 3 receives 0.7 ml of MF59 Intramuscularly (IM) on days 0 and 21. Group 4 receives MF59 on day 0, Group 5 receives MF59 on Day 21.
Emory Vaccine Center - The Hope Clinic
Decatur, Georgia, United States
University of Iowa - Infectious Disease Clinic
Iowa City, Iowa, United States
Cincinnati Children's Hospital Medical Center - Infectious Diseases
Cincinnati, Ohio, United States
University of Texas Medical Branch - Pediatrics - Infectious Diseases and Immunology - Galveston
Galveston, Texas, United States
Occurrence of solicited injection site and systemic reactogenicity on the day of each study vaccination through 7 days after each study vaccination.
Time frame: Day 0 through Day 29
Occurrence of study vaccine-related serious adverse events from the time of the first study vaccination through approximately 13 months after the first study vaccination.
Time frame: Day 0 through Day 386
Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the A/H7N9 antigen contained in the study vaccine at approximately 21 days after the second study vaccination.
Time frame: Day 42 (21 days post second study vaccination)
Percentage of subjects achieving seroconversion (pre-vaccination HAI titer <1:10 and post-vaccination HAI titer >/=1:40 or pre-vaccination HAI titer >/=1:10,minimum four-fold rise in post-vaccination HAI antibody titer).
Time frame: Day 42 (21 days post second study vaccination)
Geometric Mean Titers of serum HAI and Neut antibody at baseline and at approximately 8 and 21 days after each study vaccination.
Time frame: Day 0, 8, 21, 29, and 42
Occurrence of new-onset chronic medical conditions through 13 months after the first study vaccination
Time frame: Through Day 386 (13 months after the first vaccination)
Occurrence of unsolicited adverse events from the time of the first study vaccination through approximately 21 days after the last study vaccination.
Time frame: Day 42 (21 days post last study vaccination)
Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the A/H7N9 antigen contained in the study vaccine at approximately 8 days after the second study vaccination.
Time frame: Day 29 (8 days after the second study vaccination)
Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the A/H7N9 antigen contained in the study vaccine at baseline and at approximately 8 and 21 days after the first study vaccination
Time frame: Day 0, 8 and 21
Percentage of subjects achieving a serum Neut antibody titer of 1:40 or greater against the A/H7N9 antigen contained in the study vaccine at baseline and at approximately 8 and 21 days after each study vaccination.
Time frame: Day 0, 8, 21, 29, and 42
Percentage of subjects achieving seroconversion (pre-vaccination HAI titer <1:10 and post-vaccination HAI titer >/= 1:40 or pre-vaccination HAI titer >/= 1:10 and minimum four-fold rise post-vaccination HAI antibody titer)
Time frame: Day 29 (8 days after the second study vaccination)
Percentage of subjects achieving seroconversion (pre-vaccination HAI titer <1:10 and post-vaccination HAI titer >/=1:40 or pre-vaccination HAI titer >/=1:10 and minimum four-fold rise post-vaccination HAI antibody titer)
Time frame: Day 0, 8 and 21
Percentage of subjects achieving seroconversion (pre-vaccination Neut titer <1:10 and post-vaccination Neut titer >/=1:40 or pre-vaccination Neut titer >/=1:10 and minimum four-fold rise post-vaccination Neut antibody titer).
Time frame: Day 0, 8, 21, 29, and 42
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