Safety and Immunogenicity Study of Two Doses of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)
Primary Purpose
Influenza
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Whole virion, Vero cell-derived influenza vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Pandemic influenza
Eligibility Criteria
Inclusion Criteria:
- Are 21 to 45 years of age, inclusive, on the day of screening
- 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
- 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:
- Have a history of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza virus
- Are at high 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, metabolic, rheumatic, autoimmune, hematological or renal disorder
- Suffer from any inherited or acquired immunodeficiency
- Test positive for Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HbsAg) or Hepatitis C Virus (HCV)
- Suffer from a disease or are 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 inflammatory or degenerative neurological disease (e.g. Guillain Barré syndrome)
- Have a history of severe allergic reactions or anaphylaxis
- Have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating
- Have received a blood transfusion or immunoglobulins within 90 days of study entry
- Have donated blood or plasma within 30 days of study entry
- Have received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study
- Have undergone systemic corticoid therapy within 30 days prior to study entry
- Have a functional or surgical asplenia
- Have a known or suspected problem with alcohol or drug abuse
- Were administered an investigational drug within six weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product
- Are a member of the team conducting this study or are in a dependent relationship with the study Investigator. 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
Sites / Locations
- University of Hong Kong, Queen Mary Hospital
- Chinese University of Hong Kong, Prince of Wales Hospital
- National University Hospital
- Changi General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Intramuscular injection of whole virion, Vero cell-derived influenza vaccine containing 7.5 µg of H5N1 HA antigen per 0.5 mL in a non-adjuvanted formulation
Intramuscular injection of whole virion, Vero cell-derived influenza vaccine containing 3.75 µg of H5N1 HA antigen per 0.25 mL in a non-adjuvanted formulation
Outcomes
Primary Outcome Measures
Number of subjects with antibody response to the vaccine strain associated with protection 21 days after the second vaccination defined as titer measured by Microneutralization (MN) test >= 1:20
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00517517
Brief Title
Safety and Immunogenicity Study of Two Doses of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)
Official Title
An Open-Label Phase I/II Study to Assess the Safety and Immunogenicity of Two Doses of a Vero Cell Derived, Whole Virus Clade 2 H5N1 Influenza Vaccine in Healthy Volunteers Aged 21 to 45 Years
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ology Bioservices
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objectives of this Phase I/II study are to assess the safety and immunogenicity of two different dose levels of a non-adjuvanted H5N1 influenza vaccine in a healthy young adult population. Subjects will be randomized 1:1 to receive two intramuscular injections (21 days apart) of the vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation. Subjects will be monitored for safety and for antibody response to the vaccine. A data safety monitoring board will review the safety data after the first and second vaccination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Pandemic influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Intramuscular injection of whole virion, Vero cell-derived influenza vaccine containing 7.5 µg of H5N1 HA antigen per 0.5 mL in a non-adjuvanted formulation
Arm Title
2
Arm Type
Experimental
Arm Description
Intramuscular injection of whole virion, Vero cell-derived influenza vaccine containing 3.75 µg of H5N1 HA antigen per 0.25 mL in a non-adjuvanted formulation
Intervention Type
Biological
Intervention Name(s)
Whole virion, Vero cell-derived influenza vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation
Intervention Description
Subjects will be randomized 1:1 to receive two intramuscular injections of the whole virion, Vero cell-derived influenza vaccine containing either 3.75 mg or 7.5 mg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation on Day 0 and Day 21.
Primary Outcome Measure Information:
Title
Number of subjects with antibody response to the vaccine strain associated with protection 21 days after the second vaccination defined as titer measured by Microneutralization (MN) test >= 1:20
Time Frame
21 days after the second vaccination (= Day 42 in the study)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Are 21 to 45 years of age, inclusive, on the day of screening
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
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:
Have a history of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza virus
Are at high 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, metabolic, rheumatic, autoimmune, hematological or renal disorder
Suffer from any inherited or acquired immunodeficiency
Test positive for Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HbsAg) or Hepatitis C Virus (HCV)
Suffer from a disease or are 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 inflammatory or degenerative neurological disease (e.g. Guillain Barré syndrome)
Have a history of severe allergic reactions or anaphylaxis
Have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating
Have received a blood transfusion or immunoglobulins within 90 days of study entry
Have donated blood or plasma within 30 days of study entry
Have received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study
Have undergone systemic corticoid therapy within 30 days prior to study entry
Have a functional or surgical asplenia
Have a known or suspected problem with alcohol or drug abuse
Were administered an investigational drug within six weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product
Are a member of the team conducting this study or are in a dependent relationship with the study Investigator. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baxter Bio Science Investigator
Organizational Affiliation
Baxter Healthcare Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hong Kong, Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Chinese University of Hong Kong, Prince of Wales Hospital
City
Shatin
Country
Hong Kong
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
12. IPD Sharing Statement
Learn more about this trial
Safety and Immunogenicity Study of Two Doses of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)
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