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

NCT00783926 | Completed Phase 1 DMC

• 1 other identifier: 810801
• Study Type: interventional
• Target: 422
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Influenza; Pandemic Influenza

Outcome Measures

Primary Outcomes (1)

• Number of subjects with an antibody response to the vaccine strain associated with protection 21 days after the second vaccination

  42 days

Secondary Outcomes (1)

• Frequency and severity of systemic reactions and injection site reactions after the first and second vaccinations

  180 days

Study Arms (2)

Cohort 1

EXPERIMENTAL

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)

Cohort 2

EXPERIMENTAL

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)

Interventions

H5N1 Influenza Vaccine, Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted (reverse genetic reassortant/H5N1 hemagglutinin antigen) BIOLOGICAL

2 x 0.5 mL intramuscular injections 21 days apart (one of six different doses of hemagglutinin antigen without adjuvant)

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alachua Government Services, Inc.: lead

Study Sites (6)

Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

Location

Central Kentucky Research Associates, Inc.

Lexington, Kentucky, 40509, United States

Location

The Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

Rochester Clinical Research

Rochester, New York, 14609, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Research Across America

Dallas, Texas, 75234, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Baxter BioScience Investigator, MD

  Baxter Healthcare Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 31, 2008
• First Posted: November 3, 2008
• Study Start: July 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: July 1, 2009
• Last Updated: October 9, 2015

Record last verified: 2009-07

Locations

US (6)