Study of Seasonal Influenza Vaccine Against H5N1 Avian Influenza Virus
Evaluation of In Vitro Cross-Reactivity With Avian Influenza H5N1 Virus in Healthy Volunteers Vaccinated With a Prime Boost Regimen of Seasonal Influenza Vaccine
2 other identifiers
interventional
26
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 6, 2010
CompletedFirst Posted
Study publicly available on registry
January 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedJuly 23, 2013
July 1, 2013
8 months
January 6, 2010
July 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
antibody titers
12 weeks
Secondary Outcomes (1)
safety of 2 doses of seasonal influenza vaccine in healthy adults
12 weeks
Study Arms (4)
Autologous prime boost regimen 1
ACTIVE COMPARATORFluMist® live intranasal vaccine (LAIV) 0.2mL (0.1mL per nostril): 2 doses separated by 8 weeks (+/- 7 days)
Autologous prime boost regimen 2
ACTIVE COMPARATORFluzone® inactivated seasonal influenza virus vaccine intramuscularly: 2 doses separated by 8 weeks (+7 days)
Heterologous prime boost regimen 1
EXPERIMENTALFluMist® live, intranasal vaccine single dose, followed by Fluzone® inactivated influenza virus vaccine 8 weeks (+/-7 days) later
Heterologous prime boost regimen 2
EXPERIMENTALFluzone® inactivated seasonal influenza virus vaccine single dose, followed by FluMist® live, intranasal seasonal influenza vaccine 0.2mL 8 weeks (+/- 7 days) later
Interventions
FluMist® live, attenuated, intranasal seasonal influenza vaccine 0.2mL (0.1mL per nostril)
Fluzone® inactivated influenza virus vaccine 0.5mL intramuscularly
Eligibility Criteria
You may qualify if:
- Aged 18-49 years.
- Healthy as determined by the PI or designate
- Willing to give informed consent.
- Willing to attend follow-up appointments and undergo study procedures.
- US passport holder residing in Bangkok
- If military, have a letter of approval for participation from the chain of command (Unit Commander).
You may not qualify if:
- History of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine.
- Severe or life-threatening reaction to any previous vaccine.
- History of chronic respiratory illness, including asthma and sinusitis.
- History of heart disease
- History of kidney disease
- Metabolic disease such as diabetes
- Immunocompromised as determined by the PI, or a household contact of an immunocompromised individual.
- History of Guillain-Barre syndrome.
- Blood disease including sickle cell disease and/or bleeding tendency (by history or based on medical records).
- Any influenza vaccination within the previous 6 months, or any other vaccine within 30 days of either dose of influenza vaccine.
- Pregnant woman or nursing mother or unwilling to use reliable contraception during the study period until the final day of follow-up.
- Blood donation within the preceding 3 months, or screening hemoglobin value of \<12.5 g/dl.
- Receipt of blood products including immunoglobulins within the preceding 3 months.
- Receiving any of the following therapies: aspirin, warfarin, theophylline, phenytoin, aminopyrine, immunosuppressive drugs,
- Receipt of any antiviral agents within 48 hours of vaccine administration.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
United States Embassy Medical Unit
Bangkok, Thailand
Related Publications (1)
Bethell D, Saunders D, Jongkaewwattana A, Kramyu J, Thitithayanont A, Wiboon-ut S, Yongvanitchit K, Limsalakpetch A, Kum-Arb U, Uthaimongkol N, Garcia JM, Timmermans AE, Peiris M, Thomas S, Engering A, Jarman RG, Mongkolsirichaikul D, Mason C, Khemnu N, Tyner SD, Fukuda MM, Walsh DS, Pichyangkul S. Evaluation of in vitro cross-reactivity to avian H5N1 and pandemic H1N1 2009 influenza following prime boost regimens of seasonal influenza vaccination in healthy human subjects: a randomised trial. PLoS One. 2013;8(3):e59674. doi: 10.1371/journal.pone.0059674. Epub 2013 Mar 26.
PMID: 23555741RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Delia B Bethell, BM BCh
Armed Forces Research Institute of Medical Sciences, Thailand
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2010
First Posted
January 7, 2010
Study Start
November 1, 2009
Primary Completion
July 1, 2010
Study Completion
June 1, 2012
Last Updated
July 23, 2013
Record last verified: 2013-07