The study will be an open-label phase 2 clinical trial of a single dose of an inactivated H7N9 influenza vaccine (non-adjuvanted). The subjects of the study will have previously participated in DMID trial 07-0023, evaluating inactivated Influenza A/H7N7 vaccine. In the previous study healthy adults 18 to 40 years old were randomized to receive two doses, 28 days apart, of placebo or 7.5, 15, 45, or 90 ug of the influenza vaccine by IM injection in a 1:1 ratio (N=25/vaccine group and 25 in placebo group). The primary objectives are to 1) assess the safety and reactogenicity of a single dose A/H7N9 vaccine in individuals who previously received two IM doses of an A/H7N7 vaccine or are A/H7 vaccine-naïve and 2) To assess the serum hemagglutination inhibition (HAI) antibody responses against A/H7N9 approximately 28 days following receipt of a single dose of A/H7N9 vaccine in individuals who previously received two IM doses of A/H7N7 vaccine or are A/H7 vaccine-naïve.
This is a Phase II, open-label study in up to 50 males and non-pregnant females, 19 to 50 years old, inclusive, who are in good health and meet all entry criteria. The study is designed to assess the safety, reactogenicity, and immunogenicity of a single dose of a monovalent inactivated influenza A/H7N9 virus vaccine (45 mcg of HA/0.75 mL) manufactured by Sanofi Pasteur administered to healthy adults who previously received two doses of monovalent inactivated influenza A/H7N7 virus vaccine manufactured by Sanofi Pasteur or one or two doses of placebo in Protocol 07-0023. All subjects will receive a single dose of the inactivated influenza A/H7N9 vaccine delivered intramuscularly. Reactogenicity will be measured by the occurrence of solicited injection site and systemic reactions from the time of the study vaccination Day 1/Visit 01 through 8 days after the study vaccination. Unsolicited non-serious adverse events (AEs) will be collected from the time of the study vaccination through roughly 28 days after the study vaccination. Serious adverse events (SAEs) and new-onset chronic medical conditions will be collected from the time of the study vaccination through roughly 6 months after the study vaccination. Immunogenicity testing against A/H7N9 and A/H7N7 antigens will include performing hemagglutination inhibition (HAI) and neutralizing (Neut) antibody assays on serum obtained immediately prior to the study vaccination, and roughly 8 and 28 days after the study vaccination. An additional 60 mL of venous blood will be drawn immediately prior to the study vaccination, and roughly 8 and 28 days after the study vaccination for exploratory cellular immunology assays. The duration of this study for each subject will be roughly 6 months. The primary objectives are 1. to assess the safety and reactogenicity of a single dose monovalent inactivated influenza A/H7N9 virus vaccine in individuals who previously received two intramuscular doses of a monovalent inactivated influenza A/H7N7 virus vaccine or are A/H7 vaccine-naïve. 2. To assess the serum hemagglutination inhibition (HAI) antibody responses against A/H7N9 roughly 28 days following receipt of a single dose of a monovalent inactivated influenza A/H7N9 virus vaccine in individuals who previously received two intramuscular doses of a monovalent inactivated influenza A/H7N7 virus vaccine or are A/H7 vaccine-naïve. The secondary objectives are 1. To assess study-vaccine related unsolicited non-serious adverse events following receipt of one dose of a monovalent inactivated influenza A/H7N9 virus vaccine in individuals who previously received two intramuscular doses of a monovalent inactivated influenza A/H7N7 virus vaccine or are A/H7 vaccine-naïve. 2. To assess new-onset chronic medical conditions following receipt of one dose of a monovalent inactivated influenza A/H7N9 virus vaccine in individuals who previously received two intramuscular doses of a monovalent inactivated influenza A/H7N7 virus vaccine or are A/H7 vaccine-naïve.3) To assess the serum HAI antibody responses against A/H7N9 at baseline and about 8 days following receipt of a single dose of a monovalent inactivated influenza A/H7N9 virus vaccine in individuals who previously received two intramuscular doses of a monovalent inactivated influenza A/H7N7 virus vaccine or are A/H7 vaccine-naïve. 4. To assess the serum neutralizing (Neut) antibody responses against A/H7N9 at baseline and roughly 8 and 28 days following receipt of a one dose of a monovalent inactivated influenza A/H7N7 virus vaccine or are A/H7 vaccine-naïve.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
27
Monovalent influenza A/H7N9 virus vaccine.
Baylor College of Medicine - Molecular Virology and Microbiology
Houston, Texas, United States
Percent achieving HAI seroconversion against A/H7N9 antigen in A/H7N9 vaccine defined as either pre-vaccine HAI titer <1:10 and post-vaccine HAI titer > /= 1:40 or pre-vaccine HAI titer > /= 1:10 and minimum 4-fold rise in post-vaccine HAI antibody titer
Time frame: Approximately 28 days after the A/H7N9 study vaccination.
Occurrence of solicited injection site and systemic reactogenicity events.
Time frame: Time of the A/H7N9 study vaccination through 8 days after the A/H7N9 study vaccination.
Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the A/H7N9 antigen contained in the A/H7N9 study vaccine.
Time frame: Approximately 28 days after the A/H7N9 study vaccination.
Occurrence of study vaccine-related serious adverse events.
Time frame: Time of the A/H7N9 study vaccination through approximately 6 months after the A/H7N9 study vaccination
Percent achieve Neut seroconversion against A/H7N9 antigen in A/H7N9 vaccine, defined as either pre-vaccine Neut titer <1:10 and post-vaccine Neut titer > /= 1:40 or pre-vaccine Neut titer > /= 1:10 and min 4-fold rise in post-vaccine Neut antibody titer
Time frame: Approximately 8 and 28 days after the A/H7N9 study vaccination.
Occurrence of study vaccine-related unsolicited non-serious adverse events.
Time frame: Time of the A/H7N9 study vaccination through approximately 28 days after the A/H7N9 study vaccination.
Percentage of subjects achieving HAI seroconversion against the A/H7N9 antigen contained in the A/H7N9 study vaccine.
Time frame: Approximately 8 days after A/H7N9 the study vaccination.
Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the A/H7N9 antigen contained in the A/H7N9 study vaccine.
Time frame: At baseline and approximately 8 days after the A/H7N9 study vaccination.
Percentage of subjects achieving a serum Neut antibody titer of 1:40 or greater against the A/H7N9 antigen contained in the A/H7N9 study vaccine.
Time frame: At baseline and approximately 8 and 28 days after the A/H7N9 study vaccination.
Geometric Mean Titers of serum HAI and Neut antibodies against the A/H7N9 antigen contained in the A/H7N9 study vaccine.
Time frame: At baseline and approximately 8 and 28 days after the A/H7N9 study vaccination.
Occurrence of new-onset chronic medical conditions.
Time frame: Time of the A/H7N9 study vaccination through 6 months after the A/H7N9 study vaccination.
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