Study of Seasonal Influenza Vaccine Against H5N1 Avian Influenza Virus
Information source: Armed Forces Research Institute of Medical Sciences, Thailand
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Influenza
Intervention: FluMist® live, attenuated, intranasal seasonal influenza vaccine (Biological); Fluzone® inactivated influenza virus vaccine (Biological)
Phase: N/A
Status: Completed
Sponsored by: Armed Forces Research Institute of Medical Sciences, Thailand Official(s) and/or principal investigator(s):
Delia B Bethell, BM BCh, Principal Investigator, Affiliation: Armed Forces Research Institute of Medical Sciences, Thailand
Summary
This will be a randomized, open-label, pilot feasibility study of four 2-dose vaccine
regimens in healthy volunteers using two commercially available seasonal influenza vaccines
to compare immune responses and in vitro cross-reactivity against H5N1. Vaccine doses will
be spaced by approximately 8 weeks to allow for optimal prime boost conditions. Humoral,
cellular and secretory immune responses will be measured 2 and 4 weeks after each vaccine
dose and compared with baseline values.
Clinical Details
Official title: Evaluation of In Vitro Cross-Reactivity With Avian Influenza H5N1 Virus in Healthy Volunteers Vaccinated With a Prime Boost Regimen of Seasonal Influenza Vaccine
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: antibody titers
Secondary outcome: safety of 2 doses of seasonal influenza vaccine in healthy adults
Eligibility
Minimum age: 18 Years.
Maximum age: 49 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Aged 18-49 years.
2. Healthy as determined by the PI or designate
3. Willing to give informed consent.
4. Willing to attend follow-up appointments and undergo study procedures.
5. US passport holder residing in Bangkok
6. If military, have a letter of approval for participation from the chain of command
(Unit Commander).
Exclusion Criteria:
1. History of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine.
2. Severe or life-threatening reaction to any previous vaccine.
3. History of chronic respiratory illness, including asthma and sinusitis.
4. History of heart disease
5. History of kidney disease
6. Metabolic disease such as diabetes
7. Immunocompromised as determined by the PI, or a household contact of an
immunocompromised individual.
8. History of Guillain-Barre syndrome.
9. Blood disease including sickle cell disease and/or bleeding tendency (by history or
based on medical records).
10. Any influenza vaccination within the previous 6 months, or any other vaccine within
30 days of either dose of influenza vaccine.
11. Pregnant woman or nursing mother or unwilling to use reliable contraception during
the study period until the final day of follow-up.
12. Blood donation within the preceding 3 months, or screening hemoglobin value of <12. 5
g/dl.
13. Receipt of blood products including immunoglobulins within the preceding 3 months.
14. Receiving any of the following therapies: aspirin, warfarin, theophylline, phenytoin,
aminopyrine, immunosuppressive drugs,
15. Receipt of any antiviral agents within 48 hours of vaccine administration.
16. HIV positive on screening blood tests.
17. Any other condition that in the opinion of the study investigator warrants exclusion
from the study.
Locations and Contacts
United States Embassy Medical Unit, Bangkok, Thailand
Additional Information
Starting date: November 2009
Last updated: July 22, 2013
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