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

This study has been completed.
Sponsor:
Information provided by:
Protein Sciences Corporation
ClinicalTrials.gov Identifier:
NCT00539981
First received: October 3, 2007
Last updated: May 16, 2011
Last verified: May 2011
  Purpose

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 Intervention Phase
Influenza
Biological: Influenza Vaccine, recombinant hemagglutinin, FluBlok
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

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 efficacy of a trivalent recombinant hemagglutinin influenza vaccine in healthy adults aged 18-49 years [ Time Frame: influenza season ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Evaluation of the immunogenicity of a trivalent recombinant hemagglutinin influenza vaccine in healthy adults aged 18-49 [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 4648
Study Start Date: September 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00539981

  Show 24 Study Locations
Sponsors and Collaborators
Protein Sciences Corporation
Investigators
Principal Investigator: John J Treanor, MD University of Rochester
  More Information

Additional Information:
No publications provided

Responsible Party: Manon Cox, Protein Sciences Corporation
ClinicalTrials.gov Identifier: NCT00539981     History of Changes
Other Study ID Numbers: PSC04
Study First Received: October 3, 2007
Last Updated: May 16, 2011
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 April 21, 2014