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Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00539981
Recruitment Status : Completed
First Posted : October 5, 2007
Last Update Posted : May 19, 2011
Sponsor:
Information provided by:
Protein Sciences Corporation

Brief Summary:
The purpose of this study was to evaluate a single dose of FluBlok in terms of safety, efficacy and effectiveness in prevention of influenza and influenza-like illness and assess clinical lot-to-lot consistency in manufacturing by evaluating and comparing the immunogenicity of three different lots of FluBlok in a subset of subjects.

Condition or disease Intervention/treatment Phase
Influenza Biological: Influenza Vaccine, recombinant hemagglutinin, FluBlok Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4648 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Evaluation of the Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok® Trivalent Recombinant Baculovirus-Expressed Hemagglutinin Influenza Vaccine In Healthy Adults Aged 18 to 49
Study Start Date : September 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: FluBlok
Recombinant Trivalent Hemagglutinin Influenza Vaccine, 2007/08 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/3/2006(H1N1), A/Wisconsin/67/2005(H3N2), and B/Malaysia/2506/2004
Biological: Influenza Vaccine, recombinant hemagglutinin, FluBlok
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, FluBlok
0.5mL dose for IM injection
Other Names:
  • FluBlok
  • rHA
  • rHA0
  • recombinant hemagglutinin




Primary Outcome Measures :
  1. Evaluation of safety and reactogenicity of trivalent recombinant hemagglutinin influenza vaccine in healthy adults aged 18-49 years [ Time Frame: influenza season ]

Secondary Outcome Measures :
  1. Evaluation of the efficacy of a trivalent recombinant hemagglutinin influenza vaccine in healthy adults aged 18-49 years [ Time Frame: influenza season ]
  2. Demonstration of clinical consistency among three different lots of a trivalent recombinant hemagglutinin influenza vaccine in healthy adults aged 18-49 years [ Time Frame: 28 days ]
  3. Evaluation of the immunogenicity of a trivalent recombinant hemagglutinin influenza vaccine in healthy adults aged 18-49 [ Time Frame: 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult ages 18-49 years.
  • Provides 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 must have had a negative urine pregnancy test at the time of randomization and must be willing to use an adequate form of contraception (includes abstinence, condom with spermicide, licensed hormonal contraceptive, IUD, monogamous relationship with a vasectomized partner) during the course of the study

Exclusion Criteria:

  • Long-term use of oral steroids, parenteral steroids, or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (Nasal and topical steroids are allowed)
  • Presence of high-risk conditions or other characteristics considered to be indications for influenza vaccination, as defined by the Advisory Committee on Immunization Practices.
  • Acute febrile illness (defined as having a temperature ≥ 100degreesF) or upper respiratory tract illness within 72 hours of vaccination. Subjects with acute febrile illness may be rescheduled after fever resolved.
  • Use of experimental vaccines or any influenza vaccine other than FluBlOk after May 31st 2007 for the 2008 Southern Hemisphere or 2007 to 2008 Northern hemisphere epidemic seasons.
  • Immunosuppression as a result of an underlying illness or treatment, or used anticancer chemotherapy or radiation therapy within the preceding 36 months.
  • Any malignancy diagnosed or treated actively during the past five (5) years, with two (2) exceptions. Subject with ANY history of lymphoproliferative disorder will be excluded. However, subjects with a history of localized non-melanotic skin cancer may be eligible.
  • Receipt of any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
  • 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.
  • Receipt of parenteral immunoglobulin or other blood product within the three months prior to study vaccination.
  • 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.
  • Known active human immunodeficiency virus, hepatitis B, or hepatitis C infection.
  • History of alcohol or drug abuse in the last 5 years.
  • Not available for three or more consecutive weeks during flu surveillance period.
  • Any acute or chronic condition that, in the opinion of the investigator, would render vaccination unsafe or interfere with the evaluation of responses or render the subject unable to meet the requirements of the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00539981


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Locations
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United States, California
Impact Clinical Trials
Beverly Hills, California, United States, 90211
Benchmark Research - Sacramento
Sacramento, California, United States, 95816
Benchmark Research - San Francisco
San Francisco, California, United States, 94102
United States, Florida
University Clinical Research, Inc
Pembroke Pines, Florida, United States, 33024
United States, Kansas
Vince and Associates
Overland Park, Kansas, United States, 66212
United States, Kentucky
Kentucky pediatric /Adult Research
Bardstown, Kentucky, United States, 40004
United States, Louisiana
Benchmarch Research - New Orleans
Metairie, Louisiana, United States, 70006
United States, Maryland
University of Maryland - Baltimore
Baltimore, Maryland, United States, 21201
United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Meridian Clinical Research
Omaha, Nebraska, United States, 68134
United States, New York
Regional Clinical Research, Inc.
Endwell, New York, United States, 13760
Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Carolina Medical Trials
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Sterling Research
Cincinnati, Ohio, United States, 45246
United States, Pennsylvania
Primary Physicians Research - Pediatric Alliance St. Clair
Pittsburgh, Pennsylvania, United States, 15241
Primary Physicians Research
Pittsburg, Pennsylvania, United States, 15241
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Benchmarch Research - Austin
Austin, Texas, United States, 78705
Benchmark Research - Fort Worth
Fort Worth, Texas, United States, 76135
Baylor College of Medicine
Houston, Texas, United States, 77030
Benchmark Research - San Angelo
San Angelo, Texas, United States, 76904
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
Protein Sciences Corporation
Investigators
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Principal Investigator: John J Treanor, MD University of Rochester

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Manon Cox, Protein Sciences Corporation
ClinicalTrials.gov Identifier: NCT00539981     History of Changes
Other Study ID Numbers: PSC04
First Posted: October 5, 2007    Key Record Dates
Last Update Posted: May 19, 2011
Last Verified: May 2011
Keywords provided by Protein Sciences Corporation:
Influenza
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Hemagglutinins
Immunologic Factors
Physiological Effects of Drugs
Agglutinins