Comparison of the Immunogenicity, Safety and Reactogenicity of FluBlok, To a Licensed Vaccine In Elderly Adults
NCT ID: NCT00395174
Last Updated: 2009-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
870 participants
INTERVENTIONAL
2006-10-31
2007-05-31
Brief Summary
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Detailed Description
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Currently available TIVs are prepared from viruses that are grown in embryonated hens' eggs. Alternative substrates for vaccine production are desirable in order to reduce the vulnerability of and to expand influenza vaccine supply. Recombinant DNA techniques allow for expression of the influenza hemagglutinin (rHA) by baculovirus vectors in insect cell cultures. Advantages of this technique include speed of production, absence of egg protein, and a highly purified product. Previous studies among healthy younger and older adults have confirmed that rHA vaccines are safe, well tolerated and immunogenic at dosages up to nine times higher than those contained in TIV. Dose-related increases in serum antibody levels after immunization also were observed.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
DOUBLE
Study Groups
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FluBlok
Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2005-2006 formulation containing 45μg of each hemagglutinin derived from A/New Caledonia (H1N1), A/Wisconsin (H3N2) and B/Ohio
135μg total
Influenza Vaccination
0.5mL dose for intramuscular injection
TIV (Fluzone)
Licensed trivalent influenza vaccine (TIV): 2005-2006 formulation containing 15μg of each hemagglutinin derived from A/Wisconsin (H3N2), A/New Caledonia (H1N1) and B/Malaysia
45μg total
(Fluzone, sanofi pasteur)
Influenza Vaccination
0.5mL dose for intramuscular injection
Interventions
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Influenza Vaccination
0.5mL dose for intramuscular injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Medically stable, as determined by oral temperature \<100.0°F, medical history, and targeted physical examination based on medical history
* Able to understand and comply with planned study procedures
* Provides written informed consent prior to initiation of any study procedure.
Exclusion Criteria
* Immunosuppression as a result of an underlying illness or treatment, or used anticancer chemotherapy or radiation therapy within the preceding 36 months.
* Any malignancy (excluding nonmelanotic skin cancer or lymphoproliferative disorder), other than localized prostrate cancer, diagnosed or treated actively during the past 5 years. Subjects with any history of lymphoproliferative disorder will be excluded, while subjects with a history of localized nonmelanotic skin cancer may be eligible.
* Long-term use of oral steroids, parenteral steroids, or high-dose inhaled steroids within the preceding 6 months (Nasal and topical steroids are allowed).
* Major psychiatric diagnosis including schizophrenia, bipolar disease or other major depression, or any diagnosis of dementia or associated concomitant medications (e.g., Aricept) used for treating dementia
* History of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
* Receipt of any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
* History of severe reactions following immunization with influenza virus vaccines.
* Moderate to severe acute illness or febrile illness (oral temperature greater than 100\*F) within 1 week prior to vaccination.
* Receipt of an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month prior to enrollment in this study, or expects to receive an experimental agent during study period.
* Known active human immunodeficiency virus, hepatitis B, or hepatitis C infection.
* History of alcohol or drug abuse in the last 5 years.
* History of Guillain-Barré Syndrome.
* Any acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe, interfere with the evaluation of responses, or render the subject unable to meet the requirements of the protocol. These conditions include, but are not limited to: history of significant renal impairment (dialysis and treatment for kidney disease, including diabetic and hypertensive kidney disease); subjects with diabetes mellitus, well-controlled with oral agents may enroll as long there has been no dosage increase within the past 6 months; insulin-dependent diabetes is excluded; cardiac insufficiency, if heart failure is present (New York Heart Association Functional Class III or IV); an arteriosclerotic event during the 6 months prior to enrollment (e.g., history of myocardial infarction, stroke, recanalization of femoral arteries, or transient ischemic attack).
65 Years
ALL
Yes
Sponsors
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Protein Sciences Corporation
INDUSTRY
Responsible Party
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Protein Sciences Corporation
Principal Investigators
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Wendy A. Keitel, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Hana M. El-Sahly, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
John J. Treanor, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester Medical
Keith S. Reisinger, MD
Role: PRINCIPAL_INVESTIGATOR
Primary Physicians research
Gregory A. Poland, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic College of Medicine
Kenneth D. Lessans, MD
Role: PRINCIPAL_INVESTIGATOR
Passport Health Maryland
John J. Minneti, MD
Role: PRINCIPAL_INVESTIGATOR
Passport Health New Jersey
Kristen Lyke, MD
Role: PRINCIPAL_INVESTIGATOR
Center of Vaccine Development, University of Maryland
Locations
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Center of Vaccine Development, Univ. of Maryland
Baltimore, Maryland, United States
Passport Health Maryland
Baltimore, Maryland, United States
Mayo Clinic College of Medicine
Rochester, Minnesota, United States
Passport Health New Jersey
Shrewsbury, New Jersey, United States
Rochester Medical Center
Rochester, New York, United States
Primary Physicians Research
Pittsburgh, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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References
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Keitel WA, Treanor JJ, El Sahly HM, Gilbert A, Meyer AL, Patriarca PA, Cox MM. Comparative immunogenicity of recombinant influenza hemagglutinin (rHA) and trivalent inactivated vaccine (TIV) among persons > or =65 years old. Vaccine. 2009 Dec 11;28(2):379-85. doi: 10.1016/j.vaccine.2009.10.037. Epub 2009 Oct 29.
Rajendran M, Nachbagauer R, Ermler ME, Bunduc P, Amanat F, Izikson R, Cox M, Palese P, Eichelberger M, Krammer F. Analysis of Anti-Influenza Virus Neuraminidase Antibodies in Children, Adults, and the Elderly by ELISA and Enzyme Inhibition: Evidence for Original Antigenic Sin. mBio. 2017 Mar 21;8(2):e02281-16. doi: 10.1128/mBio.02281-16.
Nachbagauer R, Choi A, Izikson R, Cox MM, Palese P, Krammer F. Age Dependence and Isotype Specificity of Influenza Virus Hemagglutinin Stalk-Reactive Antibodies in Humans. mBio. 2016 Jan 19;7(1):e01996-15. doi: 10.1128/mBio.01996-15.
Related Links
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Related Info
Other Identifiers
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PSC03
Identifier Type: -
Identifier Source: org_study_id