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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- Resilience Government Services, Inc.
- Enrollment
- 422
- Locations
- 6
- Primary Endpoint
- Number of subjects with an antibody response to the vaccine strain associated with protection 21 days after the second vaccination
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Number of subjects with an antibody response to the vaccine strain associated with protection 21 days after the second vaccination
Time Frame: 42 days
Secondary Outcomes
- Frequency and severity of systemic reactions and injection site reactions after the first and second vaccinations(180 days)