Phase 1 Study of a H5N1 Influenza Vaccine (Reverse Genetic Reassortant)

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00783926
First received: October 31, 2008
Last updated: July 21, 2009
Last verified: July 2009
  Purpose

The objectives of this study are to assess the dose-related safety and immunogenicity of six different dose levels of inactivated, Vero cell-derived reverse genetic reassortant A/H5N1/Indonesia/05/2005 influenza vaccine in a healthy young adult population. Subjects will receive 2 vaccinations (21 days apart) at the dose to which they were assigned. Blood will be drawn from all subjects for serum antibody determination on Days 0, 21, 42 and 180. Body temperature will be measured daily for 6 days following vaccination. Injection site reactions and systemic reactions will be monitored throughout the entire 180 days of the study. Safety data obtained at 7 days after the first vaccination for all dose levels in Cohort 1 will be reviewed by a Data Monitoring Committee and a recommendation will be obtained whether to proceed to the second vaccination of Cohort 1 and to the first vaccination of Cohort 2.


Condition Intervention Phase
Influenza
Pandemic Influenza
Biological: H5N1 Influenza Vaccine, Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted (reverse genetic reassortant/H5N1 hemagglutinin antigen)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Double Blind, Multi-Center, Phase 1 Study of a Vero Cell-Derived, Whole Virus Clade 2 H5N1 Influenza Vaccine in Healthy Subjects Aged 18 to 45 Years

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Number of subjects with an antibody response to the vaccine strain associated with protection 21 days after the second vaccination [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency and severity of systemic reactions and injection site reactions after the first and second vaccinations [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]

Enrollment: 422
Study Start Date: July 2008
Study Completion Date: July 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
60 subjects randomized in an equal number to six different vaccine doses
Biological: H5N1 Influenza Vaccine, Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted (reverse genetic reassortant/H5N1 hemagglutinin antigen)
2 x 0.5 mL intramuscular injections 21 days apart (one of six different doses of hemagglutinin antigen without adjuvant)
Experimental: Cohort 2
Following review of safety data of Cohort 1, approximately 360 additional subjects randomized in an equal number to the six different vaccine doses
Biological: H5N1 Influenza Vaccine, Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted (reverse genetic reassortant/H5N1 hemagglutinin antigen)
2 x 0.5 mL intramuscular injections 21 days apart (one of six different doses of hemagglutinin antigen without adjuvant)

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects who

  • Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry
  • Are clinically healthy, as determined by the Investigator's clinical judgment through collection of medical history and performance of a physical examination
  • Are physically and mentally capable of participating in the study
  • Are willing to refrain from blood donation for the duration of Part A of the study (until Day 42 [= 21 days after the second vaccination])
  • Agree to keep a daily record of symptoms for the duration of the study
  • If female and capable of bearing children - have a negative urine pregnancy test result within 24 hours of the scheduled first vaccination and agree to employ adequate birth control measures for the duration of the study.

Exclusion Criteria:

Subjects will be excluded from participation in this study if they:

  • Have a history of exposure to H5N1 influenza virus or a history of vaccination with an H5N1 influenza vaccine
  • Are at potential occupational risk of contracting H5N1 influenza infection (e.g., poultry workers)
  • Suffer from or have a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, rheumatic, autoimmune, hematological, metabolic or renal disorder
  • Have a Body Mass Index > 35
  • Have hypertension at screening that is graded as greater than Stage 1 (defined as a systolic pressure > 159 or diastolic pressure > 99) while seated and at rest (measurement shall be repeated twice before subject is excluded)
  • Have clinically significant abnormal clinical laboratory values at screening as determined by the Investigator
  • Have clinically significant electrocardiographic abnormalities at screening
  • Test positive for HIV, HBcAb or HCV
  • Suffer from any kind of immunodeficiency
  • Suffer from a disease or were undergoing a form of treatment within 30 days of study entry or are currently undergoing a form of treatment that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (>800µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs
  • Have a history of severe allergic reactions (e.g. clinically severe urticaria, allergic rhinitis, asthma) or anaphylaxis (a medical emergency caused by an acute hypersensitivity reaction involving several organ systems including, but not limited to, cardio-respiratory signs with mucosal and/or skin changes (e.g. angioedema, etc) that presents as or rapidly progresses to a severe life-threatening reaction.
  • Have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating
  • Have received any blood products (e.g. a blood transfusion or immunoglobulins within 90 days of vaccination in this study
  • Have donated one or more units of blood (approximately 450 mL) or plasma within 30 days of vaccination in this study
  • Have received any live vaccine within 4 weeks or an inactivated vaccine or subunit vaccine within 2 weeks prior to vaccination in this study
  • Have functional or surgical asplenia
  • Have a positive urine drug screen (unless the subject is currently prescribed the drug detected by a licensed health care provider and the continued administration of the drug would not otherwise exclude the subject from participation)
  • Have a known or suspected problem with alcohol or drug abuse
  • Were administered an investigational drug within six weeks prior to study entry
  • Are concurrently participating in a clinical study that includes the administration of an investigational product
  • Are a member of the team conducting this study
  • Are in a dependent relationship with the study Investigator or with a study team member. Dependent relationships include close relatives (i.e. children, partner/spouse, siblings, parents) as well as employees of the Investigator or site conducting the study
  • If female: are pregnant or lactating
  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: NCT00783926

Locations
United States, Kansas
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67207
United States, Kentucky
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States, 40509
United States, Missouri
The Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
United States, New York
Rochester Clinical Research
Rochester, New York, United States, 14609
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, Texas
Research Across America
Dallas, Texas, United States, 75234
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: Baxter BioScience Investigator, MD Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Karen Near, MD; Medical Director, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00783926     History of Changes
Other Study ID Numbers: 810801
Study First Received: October 31, 2008
Last Updated: July 21, 2009
Health Authority: United States: Food and Drug Administration

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