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Immunogenicity and Safety of Trivalent Recombinant Hemagglutinin Influenza Vaccine in Healthy Adults
This study has been completed.
Sponsored by: Protein Sciences Corporation
Information provided by: Protein Sciences Corporation
ClinicalTrials.gov Identifier: NCT00328107
  Purpose

The objective of the study was to determine the dose-related safety, immunogenicity, and protective efficacy of an experimental trivalent purified influenzavirus hemagglutinin (rHA0) vaccine produced in insect cells using recombinant baculoviruses in healthy adults.


Condition Intervention Phase
Influenza
Biological: Influenza Vaccine, recombinant Hemagglutinin
Phase II
Phase III

MedlinePlus related topics: Flu
Drug Information available for: Influenza Vaccines Fluvirin
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Evaluation of the Immunogenicity and Safety of Two Preparations of Trivalent Recombinant Baculovirus-Expressed Hemagglutinin Influenza Vaccine Administered Intramuscularly in Healthy Adults Ages 18-49 Years.

Further study details as provided by Protein Sciences Corporation:

Primary Outcome Measures:
  • Immunogenicity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy [ Time Frame: 6 months (influenza season) ] [ Designated as safety issue: No ]
  • Effectiveness [ Time Frame: 6 months (influenza season) ] [ Designated as safety issue: No ]

Enrollment: 459
Study Start Date: November 2004
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Low Dose: Experimental
Recombinant Trivalent Hemagglutinin Influenza Vaccine, 2004/05 formulation containing 45mcg hemagglutinin derived from H3 virus and 15 mcg from H1 and B influenza viruses
Biological: Influenza Vaccine, recombinant Hemagglutinin
0.5mL dose for IM injection
High Dose: Experimental
Recombinant Trivalent Hemagglutinin Influenza Vaccine, 2004/05 formulation containing 45mcg hemagglutinin derived from H1, H3 and B influenza viruses
Biological: Influenza Vaccine, recombinant Hemagglutinin
0.5mL dose for IM injection

Detailed Description:

Background We assessed the efficacy of a recombinant hemagglutinin vaccine without adjuvant or neuraminidase in healthy subjects during the 2004-2005 influenza season.

Methods We recruited 460 healthy subjects of the age 18-49 at three different sites in the United States for this double-blinded trial; the subjects were randomly assigned to receive a single injection of placebo (154 subjects) or 75μg of a trivalent recombinant hemagglutinin vaccine containing 15μg hemagglutinin derived from either A/New Caledonia/20/99 or B/Jiangsu/10/03 influenza viruses and 45μg hemagglutinin derived from A/Wyoming/3/03 influenza virus (153 subjects) or 135μg of trivalent recombinant hemagglutinin vaccine containing 3 x 45μg hemagglutinin (153 subjects). The subjects were followed during the influenza season or 6 months following injection. Serum samples were taken at time points 0, day 30 and 6 months following injection. In addition, nasal swaps were taken from individuals that presented with influenza-like illness (CDC-ILI).

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Medically stable adults, aged 18-49 years.
  • Provided informed consent prior to any study procedures.
  • Able to comply with all study procedures.
  • Available for follow-up for the duration of the influenza season.
  • Women of child-bearing potential had a negative urine pregnancy test at the time of randomization and were willing to use an adequate form of contraception during the course of the study.

Exclusion Criteria:

  • Any history of immunodeficiency or treatment with immunosuppressive medications. (Use of inhaled steroids or of topical steroids was not considered immunosuppressive; receipt of systemic glucocorticosteroids was not allowed if daily intake was >10 mg of prednisone or equivalent).
  • Presence of high-risk conditions or other characteristics considered to be indications for influenza vaccination, as defined by the Advisory Committee on Immunization Practices (ACIP).
  • Acute febrile illness (defined as having a temperature ≥100degreesF) or upper respiratory tract illness within 72 hours of vaccination.
  • Use of experimental vaccines or any influenza vaccine after May 31st 2004 for the 2005 Southern Hemisphere or 2004 to 2005 Northern hemisphere epidemic seasons.
  • Use of any experimental medication within 30 days prior to study vaccination
  • Women who were pregnant or breast-feeding.
  • Subjects with a history of Guillain-Barré syndrome.
  • Receipt of parenteral immunoglobulin within 30 days prior to study vaccination.
  • Any acute or chronic condition that, in the opinion of the investigator, would render vaccination unsafe or interfere with the evaluation of response.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00328107

Locations
United States, New York
Rochester Medical Center
Rochester, New York, United States, 14642
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Protein Sciences Corporation
Investigators
Principal Investigator: John Treanor, MD University of Rochester
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Publications of Results:
Responsible Party: Protein Sciences Corporation ( Manon MJ Cox )
Study ID Numbers: PSC01
Study First Received: May 17, 2006
Last Updated: January 10, 2008
ClinicalTrials.gov Identifier: NCT00328107  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Healthy
Orthomyxoviridae Infections

Additional relevant MeSH terms:
RNA Virus Infections

ClinicalTrials.gov processed this record on January 15, 2009