Comparison of the Immunogenicity, Safety and Reactogenicity of FluBlok, To a Licensed Vaccine In Elderly Adults

This study has been completed.
Sponsor:
Information provided by:
Protein Sciences Corporation
ClinicalTrials.gov Identifier:
NCT00395174
First received: October 30, 2006
Last updated: December 16, 2009
Last verified: December 2009
  Purpose

The purpose of this study were to obtain additional evidence in support of the safety and immunogenicity of a recombinant hemagglutinin (rHA) vaccine in an elderly population, and to establish non-inferiority of the immunogenicity of the rHA vaccine when compared with a licensed trivalent influenza vaccine (TIV). Another purpose was to provide a preliminary estimate of the relative efficacy of the two vaccines against culture-positive influenza-like illness during the subsequent epidemic.


Condition Intervention Phase
Influenza
Biological: Influenza Vaccination
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Comparison of the Immunogenicity, Safety and Reactogenicity of FluBlok, Trivalent Recombinant Baculovirus-Expressed Hemagglutinin Influenza Vaccine, to a Licensed Egg-Grown Influenza Vaccine In Ambulatory Elderly Adults

Resource links provided by NLM:


Further study details as provided by Protein Sciences Corporation:

Primary Outcome Measures:
  • Evaluation of safety and reactogenicity of FluBlok and TIV in medically stable adults 65 years and older. [ Time Frame: influenza season ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Comparison of relative efficacy and effectiveness of FluBlok and TIV in medically stable adults 65 years and older. [ Time Frame: influenza season ] [ Designated as safety issue: No ]
  • Evaluation and comparison of immunogenicity of FluBlok and TIV in medically stable adults 65 years and older. [ Time Frame: influenza season ] [ Designated as safety issue: No ]

Enrollment: 870
Study Start Date: October 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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

Biological: Influenza Vaccination
0.5mL dose for intramuscular injection
Other Names:
  • FluBlok
  • Fluzone
  • rHA
  • rHA0
  • recombinant hemagglutinin
  • TIV
Active Comparator: 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)

Biological: Influenza Vaccination
0.5mL dose for intramuscular injection
Other Names:
  • FluBlok
  • Fluzone
  • rHA
  • rHA0
  • recombinant hemagglutinin
  • TIV

Detailed Description:

Annual influenza epidemics are associated with serious excess morbidity and mortality, particularly among the elderly. Licensed trivalent inactivated influenza vaccines (TIVs) have been shown to reduce hospitalization and death following influenza in this vulnerable population, but their efficacy is lower than that observed in younger, healthy populations. In addition, recent studies have questioned the level of effectiveness of TIV in the elderly, suggesting that cohort studies have overestimated the benefits of immunization with current TIV formulations in this age group. In view of these considerations, it is widely accepted that improved and alternative vaccines are needed for control of seasonal and pandemic influenza.

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ambulatory adults aged 65 and older
  • 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:

  • Known allergy to eggs or other vaccine components.
  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395174

Locations
United States, Maryland
Center of Vaccine Development, Univ. of Maryland
Baltimore, Maryland, United States, 21201
Passport Health Maryland
Baltimore, Maryland, United States, 21230
United States, Minnesota
Mayo Clinic College of Medicine
Rochester, Minnesota, United States, 55905
United States, New Jersey
Passport Health New Jersey
Shrewsbury, New Jersey, United States, 07702
United States, New York
Rochester Medical Center
Rochester, New York, United States, 14642
United States, Pennsylvania
Primary Physicians Research
Pittsburg, Pennsylvania, United States, 15241
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Protein Sciences Corporation
Investigators
Principal Investigator: Wendy A. Keitel, MD Baylor College of Medicine
Principal Investigator: Hana M. El-Sahly, MD Baylor College of Medicine
Principal Investigator: John J. Treanor, MD University of Rochester Medical
Principal Investigator: Keith S. Reisinger, MD Primary Physicians research
Principal Investigator: Gregory A. Poland, MD Mayo Clinic College of Medicine
Principal Investigator: Kenneth D. Lessans, MD Passport Health Maryland
Principal Investigator: John J. Minneti, MD Passport Health New Jersey
Principal Investigator: Kristen Lyke, MD Center of Vaccine Development, University of Maryland
  More Information

Additional Information:
Publications:
Responsible Party: Manon Cox, Chief Operating Officer, Protein Sciences Corporation
ClinicalTrials.gov Identifier: NCT00395174     History of Changes
Other Study ID Numbers: PSC03
Study First Received: October 30, 2006
Last Updated: December 16, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Protein Sciences Corporation:
Influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases
Hemagglutinins
Agglutinins
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014