Immunogenicity and Safety of Trivalent Recombinant Hemagglutinin Influenza Vaccine in Healthy Adults

This study has been completed.
Sponsor:
Information provided by:
Protein Sciences Corporation
ClinicalTrials.gov Identifier:
NCT00328107
First received: May 17, 2006
Last updated: January 8, 2010
Last verified: January 2010
  Purpose

The purpose of this study was to determine the dose-related safety, immunogenicity, and protective efficacy of a trivalent recombinant hemagglutinin influenza vaccine in healthy adults.


Condition Intervention Phase
Influenza
Biological: Influenza Vaccine, recombinant Hemagglutinin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Protein Sciences Corporation:

Primary Outcome Measures:
  • Evaluation of safety and reactogenicity of trivalent recombinant hemagglutinin influenza vaccine in healthy adults aged 18-49 years [ Time Frame: influenza season ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluation of the protective efficacy of a trivalent recombinant hemagglutinin influenza vaccine at two different formulations in healthy adults aged 18-49 years [ Time Frame: influenza season ] [ Designated as safety issue: No ]
  • Evaluation of the immunogenicity of the H1 and B components when formulated at either 15μg or 45μg per component in healthy adults aged 18-49 years [ Time Frame: 28 days ] [ 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
Experimental: Low Dose
Recombinant Trivalent Hemagglutinin Influenza Vaccine, 2004/05 formulation containing 45μg of each hemagglutinin derived from A/Wyoming/3/03(H3N2) and 15μg from A/New Caledonia/20/99(H1N1) and B/Jiangsu/10/03
Biological: Influenza Vaccine, recombinant Hemagglutinin
0.5mL dose for IM injection
Other Names:
  • FluBlok
  • rHA
  • rHA0
  • recombinant hemagglutinin
Experimental: Full Dose
Recombinant Trivalent Hemagglutinin Influenza Vaccine, 2004/05 formulation containing 45μg of each hemagglutinin derived from A/Wyoming/3/03(H3N2), A/New Caledonia/20/99(H1N1) and B/Jiangsu/10/03
Biological: Influenza Vaccine, recombinant Hemagglutinin
0.5mL dose for IM injection
Other Names:
  • FluBlok
  • rHA
  • rHA0
  • recombinant hemagglutinin
Placebo Comparator: Placebo
0.9% Sodium Chloride
Biological: Influenza Vaccine, recombinant Hemagglutinin
0.5mL dose for IM injection
Other Names:
  • FluBlok
  • rHA
  • rHA0
  • recombinant hemagglutinin

Detailed Description:

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.

  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
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: 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

Additional Information:
Publications:
Responsible Party: Manon MJ Cox, Protein Sciences Corporation
ClinicalTrials.gov Identifier: NCT00328107     History of Changes
Other Study ID Numbers: PSC01
Study First Received: May 17, 2006
Last Updated: January 8, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Protein Sciences Corporation:
Influenza

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

ClinicalTrials.gov processed this record on September 18, 2014