Status:
COMPLETED
Study to Assess Safety of an Inactivated H5N1 Influenza Vaccine Administered in GelVac Nasal Powder to Healthy Young Adults
Lead Sponsor:
Alachua Government Services, Inc.
Conditions:
Phase 1 Safety Study of GelVac Nasal Powder H5N1 Influenza Vaccine
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
Brief Summary
This is a double-blind, placebo controlled, safety and immunogenicity study of GelVac™ nasal powder H5N1 influenza vaccine. Healthy male and female subjects between 18 and 49 years of age who are elig...
Eligibility Criteria
Inclusion
- able to read and sign Informed Consent Form (ICF).
- male or female \> 18 and \< 49 years of age at the time the ICF is signed.
- generally healthy, as determined by medical history and clinical assessment.
- able to attend all scheduled visits and to comply with all trial procedures.
- if female of child-bearing potential, use of an acceptable method of contraception or abstinence for at least 4 weeks prior to the first vaccination through at least four weeks after the second vaccination. Acceptable methods are hormonal birth control or a barrier method with spermicide.
- if female, post menopausal (no menstrual period within the last 12 months), surgically sterile (hysterectomy or tubal ligation), or have a negative urine pregnancy test within 24 hours prior to the time of vaccination.
Exclusion
- has a known allergy to fruits (e.g., apples, oranges) or pectin and/or pectin by-products (including jams or jellies).
- has a known allergy to dairy/milk products/lactose.
- is breast-feeding or pregnant or planning on becoming pregnant within 1 month of vaccination.
- has a history of a chronic viral infection (i.e.; Shingles, Herpes Zoster, HIV).
- has a history of severe allergic reaction following influenza vaccination, systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing the same substances.
- has a history of demyelinating disease (esp. Guillian-Barre Syndrome).
- history of Bell's Palsy.
- immunosuppression as a result of underlying illness or treatment.
- use of oral steroids, parenteral steroids, or high-dose inhaled steroids (\>800 µg/day of beclomethasone dipropionate or equivalent) within 1 month prior to vaccination.
- use of other immunosuppressive or cytotoxic drugs or radiation therapy within six months prior to vaccination.
- use of OTC or other 'herbal' immune suppressant or stimulants within the 6 months prior to vaccination.
- active neoplastic disease or history of any hematologic malignancy in the past 5 years (except localized skin or prostate cancer that is stable in the absence of therapy).
- acute or chronic condition that (in the opinion of the Investigator) would render vaccination unsafe or would interfere with the evaluation of responses including, but not limited to the following: known chronic liver disease, significant renal disease, oxygen-dependent chronic lung disease, New York Heart Association Functional Class III or IV, unstable or progressive neurologic disorder, insulin-treated diabetes mellitus, and asthma.
- use of experimental vaccines within 6 months prior to study entry, or expected use of experimental vaccines during the entire study period after inoculation with study vaccine.
- participation in another clinical trial 30 days prior to study entry.
- use of experimental devices or participation in a medical procedure trial within the month prior to study entry, or expected use of experimental devices or participation in a medical procedure trial during the entire study period.
- receipt of immunoglobulin or other blood product within 3 months prior to enrollment.
- receipt of other licensed vaccines within the preceding 6 months or expected to receive a licensed vaccine within 28 days following last trial vaccination.
- subject is enrolled in a conflicting clinical trial.
- any disorder or therapy contraindicating influenza vaccination.
- Have a clinically significant structural abnormality of the nasopharynx (e.g., obvious deviation that obstructs airflow in either nostril), as determined by the investigator
- acute respiratory disease at the time of enrollment.
- febrile illness with temperature greater than or equal to 38 degrees Celsius (100.4 degrees F) within 72 hours prior to enrollment.
- receipt of allergy shots within the preceding 7 days or expected to receive allergy shots within 7 days following vaccination.
- any condition that, in the opinion of the investigator, would pose a health risk to the participant.
- presence of any active disease or condition at the administration site that, in the opinion of the Investigator, would impact vaccine delivery or assessment of vaccination site.
- history of drug abuse or alcohol abuse in the five years prior to enrollment. Subject who abuses alcohol or other drugs of abuse.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01258062
Start Date
September 1 2010
End Date
April 1 2011
Last Update
February 2 2017
Active Locations (1)
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1
Florida Research Network, LLC
Gainesville, Florida, United States, 32605