Study of Seasonal Influenza Vaccine Against H5N1 Avian Influenza Virus

July 22, 2013 updated by: Armed Forces Research Institute of Medical Sciences, Thailand

Evaluation of In Vitro Cross-Reactivity With Avian Influenza H5N1 Virus in Healthy Volunteers Vaccinated With a Prime Boost Regimen of Seasonal Influenza Vaccine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand
        • United States Embassy Medical Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
antibody titers
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
safety of 2 doses of seasonal influenza vaccine in healthy adults
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Armed Forces Research Institute of Medical Sciences, Thailand

Investigators

  • Principal Investigator: Delia B Bethell, BM BCh, Armed Forces Research Institute of Medical Sciences, Thailand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

January 6, 2010

First Submitted That Met QC Criteria

January 6, 2010

First Posted (Estimate)

January 7, 2010

Study Record Updates

Last Update Posted (Estimate)

July 23, 2013

Last Update Submitted That Met QC Criteria

July 22, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WRAIR1525
  • HSRRB No. A-15223 (Other Identifier: Human Subjects Research Review Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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