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

January 8, 2010 updated by: Protein Sciences Corporation

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

459

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • Rochester Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • recombinant hemagglutinin
  • rHA
  • rHA0
  • FluBlok
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:
  • recombinant hemagglutinin
  • rHA
  • rHA0
  • FluBlok
PLACEBO_COMPARATOR: Placebo
0.9% Sodium Chloride
Biological: Influenza Vaccine, recombinant Hemagglutinin
0.5mL dose for IM injection
Other Names:
  • recombinant hemagglutinin
  • rHA
  • rHA0
  • FluBlok

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of safety and reactogenicity of trivalent recombinant hemagglutinin influenza vaccine in healthy adults aged 18-49 years
Time Frame: influenza season
influenza season

Secondary Outcome Measures

Outcome Measure
Time Frame
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
influenza season
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
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Protein Sciences Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (ACTUAL)

August 1, 2005

Study Completion (ACTUAL)

August 1, 2005

Study Registration Dates

First Submitted

May 17, 2006

First Submitted That Met QC Criteria

May 17, 2006

First Posted (ESTIMATE)

May 19, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

January 12, 2010

Last Update Submitted That Met QC Criteria

January 8, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSC01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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