Status:
COMPLETED
Phase 1 Study of a H5N1 Influenza Vaccine (Reverse Genetic Reassortant)
Lead Sponsor:
Alachua Government Services, Inc.
Conditions:
Influenza
Pandemic Influenza
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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/05/200...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
422 Patients enrolled
Trial Details
Trial ID
NCT00783926
Start Date
July 1 2008
End Date
July 1 2009
Last Update
October 9 2015
Active Locations (6)
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1
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67207
2
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States, 40509
3
The Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
4
Rochester Clinical Research
Rochester, New York, United States, 14609