Influenza
Conditions
Keywords
Influenza, Immunogenicity, Monovalent, A/H7N9, Vaccine, AS03, Adjuvant
Brief summary
This Phase II randomized, double-blinded, controlled study in up to 1000 males and non-pregnant females, 19 to 64 years old, inclusive, who are in good health and meet all eligibility criteria is designed to provide data on an A/H7N9 vaccine made with HA antigen derived from the influenza A/Shanghai/2/2013 virus.
Detailed description
This Phase II randomized, double-blinded, controlled study in up to 1000 males and non-pregnant females, 19 to 64 years old, inclusive, who are in good health and meet all eligibility criteria is designed to provide data on an A/H7N9 vaccine made with HA antigen derived from the influenza A/Shanghai/2/2013 virus. The study aims to address several critical questions, including the safety, reactogenicity, and immunogenicity of a monovalent influenza A/H7N9 virus vaccine manufactured by Sanofi Pasteur: 1) two doses administered at different dosages (3.75, 7.5, or 15 mcg of HA/0.5 mL dose) given with AS03 adjuvant manufactured by GlaxoSmithKline Biologicals or without adjuvant (15 mcg of HA/0.5 mL dose and 45 mcg of HA/0.75 mL dose); and 2) a combination of two doses of the A/H7N9 vaccine (15 mcg of HA/0.5 mL dose) each administered with a different adjuvant (AS03 or MF59 manufactured by Novartis Vaccines and Diagnostics); and 3) two doses administered at 15 mcg of HA/0.5 mL dose given with MF59 adjuvant manufactured by Novartis Vaccines and Diagnostics.
Interventions
DRUGAS03
Subjects will receive two doses of the A/H7N9 vaccine with or without AS03 delivered intramuscularly 21 days apart.
DRUGMF59
Subjects will receive two doses of the A/H7N9 vaccine with or without MF59 delivered intramuscularly 21 days apart.
Subjects will receive two doses of the A/H7N9 vaccine with or without an adjuvant delivered intramuscularly approximately 21 days apart.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Provide written informed consent prior to initiation of any study procedures. * Are able to understand and comply with planned study procedures and be available for all study visits. * Are males or non-pregnant females, 19 to 64 years old, inclusive. * Are in good health, as determined by vital signs (oral temperature, pulse, and blood pressure), medical history, and targeted physical examination based on medical history to ensure any existing medical diagnoses or conditions (except those in the Subject
Exclusion criteria
) are stable . Subjects may be on chronic1 or as needed (prn) medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity. Note: Topical, nasal, and inhaled medications (with the exception of steroids as outlined in the Subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects achieving seroconversion (defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination HAI titer >/=1:40 or a pre-vaccination HAI titer >/=1:10 and a minimum four-fold rise in post-vaccination HAI antibody titer). | Day 42 (21 days post second study vaccination) |
| Occurrence of solicited injection site and systemic reactogenicity on the day of each study vaccination through 7 days after each study vaccination. | Day 0 though 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. | 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. | Day 42 (21 days post second study vaccination) |
| Occurrence of clinical safety laboratory adverse events from the time of each study vaccination through approximately 8 days after each study vaccination. | Day 0 through Day 29 |
Secondary
| Measure | Time frame |
|---|---|
| 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 | Day 0, 8, 21, 29, and 42 |
| 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. | Day 29 (8 days after the second study vaccination) |
| Percentage of subjects achieving seroconversion (defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination HAI titer >/=1:40 or a pre-vaccination HAI titer >/=1:10 and a minimum four-fold rise in post-vaccination HAI antibody titer) | Day 0, 8 and 21 |
| 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. | Days 0, 8 and 21 |
| Occurrence of new-onset chronic medical conditions through 13 months after the first study vaccination. | Through Day 386 (13 months after the first vaccination) |
| Percentage of subjects achieving seroconversion (defined as either a pre-vaccination Neut titer <1:10 and a post-vaccination Neut titer >/= 1:40 or a pre-vaccination Neut titer >/=1:10 and a minimum four-fold rise in post-vaccination Neut antibody titer) | Day 0, 8, 21, 29, and 42 |
| Percentage of subjects achieving seroconversion (defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination HAI titer >/=1:40 or a pre-vaccination HAI titer >/=1:10 and a minimum four-fold rise in post-vaccination HAI antibody titer). | Day 29 (8 days after the second study vaccination) |
| Occurrence of unsolicited adverse events from the time of the first study vaccination through approximately 21 days after the last study vaccination. | Day 42 (21 days post last study vaccination |
| Geometric Mean Titers of serum HAI and Neut antibody at baseline and at approximately 8 and 21 days after each study vaccination. | Days 0, 8, 21, 29, and 42 |
Countries
United States
Outcome results
None listed