Study of Seasonal Influenza Vaccine Against H5N1 Avian Influenza Virus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Armed Forces Research Institute of Medical Sciences, Thailand
ClinicalTrials.gov Identifier:
NCT01044095
First received: January 6, 2010
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Influenza
Biological: FluMist® live, attenuated, intranasal seasonal influenza vaccine
Biological: Fluzone® inactivated influenza virus vaccine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Armed Forces Research Institute of Medical Sciences, Thailand:

Primary Outcome Measures:
  • antibody titers [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety of 2 doses of seasonal influenza vaccine in healthy adults [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 26
Study Start Date: November 2009
Study Completion Date: June 2012
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Autologous prime boost regimen 1
FluMist® live intranasal vaccine (LAIV) 0.2mL (0.1mL per nostril): 2 doses separated by 8 weeks (+/- 7 days)
Biological: FluMist® live, attenuated, intranasal seasonal influenza vaccine
FluMist® live, attenuated, intranasal seasonal influenza vaccine 0.2mL (0.1mL per nostril)
Active Comparator: Autologous prime boost regimen 2
Fluzone® inactivated seasonal influenza virus vaccine intramuscularly: 2 doses separated by 8 weeks (+7 days)
Biological: Fluzone® inactivated influenza virus vaccine
Fluzone® inactivated influenza virus vaccine 0.5mL intramuscularly
Experimental: Heterologous prime boost regimen 1
FluMist® live, intranasal vaccine single dose, followed by Fluzone® inactivated influenza virus vaccine 8 weeks (+/-7 days) later
Biological: FluMist® live, attenuated, intranasal seasonal influenza vaccine
FluMist® live, attenuated, intranasal seasonal influenza vaccine 0.2mL (0.1mL per nostril)
Biological: Fluzone® inactivated influenza virus vaccine
Fluzone® inactivated influenza virus vaccine 0.5mL intramuscularly
Experimental: Heterologous prime boost regimen 2
Fluzone® inactivated seasonal influenza virus vaccine single dose, followed by FluMist® live, intranasal seasonal influenza vaccine 0.2mL 8 weeks (+/- 7 days) later
Biological: FluMist® live, attenuated, intranasal seasonal influenza vaccine
FluMist® live, attenuated, intranasal seasonal influenza vaccine 0.2mL (0.1mL per nostril)
Biological: Fluzone® inactivated influenza virus vaccine
Fluzone® inactivated influenza virus vaccine 0.5mL intramuscularly

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01044095

Locations
Thailand
United States Embassy Medical Unit
Bangkok, Thailand
Sponsors and Collaborators
Armed Forces Research Institute of Medical Sciences, Thailand
Investigators
Principal Investigator: Delia B Bethell, BM BCh Armed Forces Research Institute of Medical Sciences, Thailand
  More Information

Additional Information:
Publications:
Responsible Party: Armed Forces Research Institute of Medical Sciences, Thailand
ClinicalTrials.gov Identifier: NCT01044095     History of Changes
Other Study ID Numbers: WRAIR1525, HSRRB No. A-15223
Study First Received: January 6, 2010
Last Updated: July 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Armed Forces Research Institute of Medical Sciences, Thailand:
seasonal influenza vaccine
avian influenza H5N1
cross reactivity
prime boost

Additional relevant MeSH terms:
Influenza, Human
Influenza in Birds
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 01, 2014