The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Anhui/1/2013 (H7N9) administered at 3 dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an unadjuvanted rHA formulation.
All currently licensed influenza vaccines in the United States are produced in embryonated hen's eggs. There are several well-recognized disadvantages to the use of eggs as the substrate for influenza vaccine. Eggs require specialized manufacturing facilities and could be difficult to scale up rapidly in response to an emerging need such as a pandemic. It is usually necessary to adapt candidate vaccine viruses for high-yield growth in eggs, a process that can be time consuming, is not always successful, and can select receptor variants that may have suboptimal immunogenicity. In addition, agricultural diseases that affect chicken flocks, and that might be an important issue in a pandemic due to an avian influenza virus strain, could easily disrupt the supply of eggs for vaccine manufacturing. Therefore, development of alternative substrates for influenza vaccine production has been identified as a high-priority objective. One potential alternative method for production of influenza vaccine is expression of the influenza virus hemagglutinin (HA) using recombinant DNA techniques. This alternative avoids dependence on eggs and is very efficient because of the high levels of protein expression under the control of the baculovirus polyhedrin promoter.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
407
Intramuscular injection
Intramuscular injection
Coastal Clinical Research
Mobile, Alabama, United States
Avail Clinical Research
DeLand, Florida, United States
Meridian Clinical Research
Savannah, Georgia, United States
Meridian Clinical Research
Omaha, Nebraska, United States
Demonstrate That the Immunogenicity of Adjuvanted Panblok H7 rHA is Sufficient to Support Emergency Use Authorization in the Event of a Declared Pandemic.
The primary endpoint will be "seroprotection rate" to the selected dose of adjuvanted H7 rHA, defined by a post-vaccination HAI titer ≥40 on Day 42. The definition of success will be a lower bound of the two-sided 95% CI ≥ 70% for adults \<65 and ≥60% for adults ≥65 years of age.
Time frame: 42 Days
Reactogenicity Immediately After Each Injection, Extending to Day 7
Solicited events of local and systemic reactogenicity Days 0-7
Time frame: 7 Days
Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination
Time frame: 13 months
Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine
Unsolicited adverse events (UAEs) Days 0-42.
Time frame: 42 Days
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Regional Clinical Research, Inc.
Endwell, New York, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, United States
Benchmark Reseach
Austin, Texas, United States
Benchmark Research - Fort Worth
Fort Worth, Texas, United States
Jean Brown Research
Salt Lake City, Utah, United States