Back to resultsStudy of Seasonal Influenza Vaccine Against H5N1 Avian Influenza Virus
Primary Purpose
Influenza
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
FluMist® live, attenuated, intranasal seasonal influenza vaccine
Fluzone® inactivated influenza virus vaccine
Sponsored by
About this trial
This is an interventional basic science trial for Influenza focused on measuring seasonal influenza vaccine, avian influenza H5N1, cross reactivity, prime boost
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
- HIV positive on screening blood tests.
- Any other condition that in the opinion of the study investigator warrants exclusion from the study.
Sites / Locations
- United States Embassy Medical Unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Experimental
Experimental
Arm Label
Autologous prime boost regimen 1
Autologous prime boost regimen 2
Heterologous prime boost regimen 1
Heterologous prime boost regimen 2
Arm Description
FluMist® live intranasal vaccine (LAIV) 0.2mL (0.1mL per nostril): 2 doses separated by 8 weeks (+/- 7 days)
Fluzone® inactivated seasonal influenza virus vaccine intramuscularly: 2 doses separated by 8 weeks (+7 days)
FluMist® live, intranasal vaccine single dose, followed by Fluzone® inactivated influenza virus vaccine 8 weeks (+/-7 days) later
Fluzone® inactivated seasonal influenza virus vaccine single dose, followed by FluMist® live, intranasal seasonal influenza vaccine 0.2mL 8 weeks (+/- 7 days) later
Outcomes
Primary Outcome Measures
antibody titers
Secondary Outcome Measures
safety of 2 doses of seasonal influenza vaccine in healthy adults
Full Information
NCT ID
NCT01044095
First Posted
January 6, 2010
Last Updated
July 22, 2013
Sponsor
Armed Forces Research Institute of Medical Sciences, Thailand
1. Study Identification
Unique Protocol Identification Number
NCT01044095
Brief Title
Study of Seasonal Influenza Vaccine Against H5N1 Avian Influenza Virus
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 Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Armed Forces Research Institute of Medical Sciences, Thailand
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
seasonal influenza vaccine, avian influenza H5N1, cross reactivity, prime boost
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Autologous prime boost regimen 1
Arm Type
Active Comparator
Arm Description
FluMist® live intranasal vaccine (LAIV) 0.2mL (0.1mL per nostril): 2 doses separated by 8 weeks (+/- 7 days)
Arm Title
Autologous prime boost regimen 2
Arm Type
Active Comparator
Arm Description
Fluzone® inactivated seasonal influenza virus vaccine intramuscularly: 2 doses separated by 8 weeks (+7 days)
Arm Title
Heterologous prime boost regimen 1
Arm Type
Experimental
Arm Description
FluMist® live, intranasal vaccine single dose, followed by Fluzone® inactivated influenza virus vaccine 8 weeks (+/-7 days) later
Arm Title
Heterologous prime boost regimen 2
Arm Type
Experimental
Arm Description
Fluzone® inactivated seasonal influenza virus vaccine single dose, followed by FluMist® live, intranasal seasonal influenza vaccine 0.2mL 8 weeks (+/- 7 days) later
Intervention Type
Biological
Intervention Name(s)
FluMist® live, attenuated, intranasal seasonal influenza vaccine
Intervention Description
FluMist® live, attenuated, intranasal seasonal influenza vaccine 0.2mL (0.1mL per nostril)
Intervention Type
Biological
Intervention Name(s)
Fluzone® inactivated influenza virus vaccine
Intervention Description
Fluzone® inactivated influenza virus vaccine 0.5mL intramuscularly
Primary Outcome Measure Information:
Title
antibody titers
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
safety of 2 doses of seasonal influenza vaccine in healthy adults
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.
HIV positive on screening blood tests.
Any other condition that in the opinion of the study investigator warrants exclusion from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Delia B Bethell, BM BCh
Organizational Affiliation
Armed Forces Research Institute of Medical Sciences, Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
United States Embassy Medical Unit
City
Bangkok
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
23555741
Citation
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.
Results Reference
result
Links:
URL
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0059674
Description
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Study of Seasonal Influenza Vaccine Against H5N1 Avian Influenza Virus
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