The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Indonesia/05/2005 (H5N1) administered at 3 dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an un-adjuvanted 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
341
Intramuscular injection
Intramuscular injection
Meridian Clinical Research
Omaha, Nebraska, United States
University of Rochester Center for Vaccine Studies
Rochester, New York, United States
Benchmark Reseach
Austin, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
The Difference in Seroconversion/Immunogenicity Between rHA Formulated in an oil-in- Water Adjuvant (SE) Compared to a rHA Antigen Alone.
Immunogenicity was assessed by measuring the percentage of subjects in each group exhibiting seroconversion on Day 42. The treatment groups that received adjuvanted rHA were evaluated against a non-adjuvanted rHA treatment group for whether they demonstrated seroconversion rates and 95% confidence intervals.
Time frame: 42 Days
The Difference in Geometric Mean Titer Between rHA Formulated in an oil-in- Water Adjuvant (SE) Compared to a rHA Antigen Alone.
Time frame: 42 Days
Reactogenicity Immediately After Each Injection, Extending to Day 7.
Solicited events of local and systemic reactogenicity Days 0-7. These events are expected to occur and not considered or recorded as Adverse Events.
Time frame: 7 Days
Long-term Safety
Incidence of Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCIs) and Adverse Events of Special Interest (AESIs) over 12 months following vaccination. Study subjects were followed every three months (for one year following Day 42) by telephone and visit for reports of SAEs, NOCIs, and AESIs.
Time frame: 13 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Jean Brown Research
Salt Lake City, Utah, United States