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Phase I Safety and Immunogenicity of Live Attenuated Influenza H5 Candidate Vaccine Strain A/17/Turkey/Turkey/05/133 (H5N2) in Healthy Thai Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Punnee Pitisuttithum, Mahidol University
ClinicalTrials.gov Identifier:
NCT01656356
First received: July 25, 2012
Last updated: August 7, 2012
Last verified: August 2012
History of Changes
  Purpose

The purpose of this study is to evaluate safety and reactogenicity of live attenuated influenza H5 vaccine candidate strain A/17/turkey/Turkey/05/133 (H5N2) manufactured by GPO, in Thailand to previously healthy Thais.


Condition Intervention Phase
Preventive Avian Flu
 Biological: Avian Flu Vaccine
Biological: Placebo
 Phase 1

Study Type: Interventional
Official Title: Phase I Safety and Immunogenicity of Live Attenuated Influenza H5 Candidate Vaccine Strain A/17/Turkey/Turkey/05/133 (H5N2) in Healthy Thai Volunteers

Resource links provided by NLM:

MedlinePlus related topics: Bird Flu Flu
U.S. FDA Resources

Further study details as provided by Mahidol University:

Study Start Date: May 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A/17/turkey/Turkey/05/133 (H5N2) Biological: Avian Flu Vaccine
Placebo Comparator: Placebo Biological: Placebo

Detailed Description:

It is a phase I randomized placebo controlled trial (vaccine and placebo ratio of 2:1). A phase II study is planned to be conducted following review of results of this phase.

Phase I: It is a double blind randomized placebo controlled trial involving 24 participants age 18-49 years (16 will receive vaccines and 8 will receive placebo). All will be admitted in the isolation ward for 10-14 days after each immunization mainly for safety assessment. Two doses of live attenuated influenza H5 vaccine candidate strain A/17/turkey/Turkey/05/133 (H5N2) will be given by intranasal route 21 days apart. Each group of 4 participants will be immunized at a time at 30-60 mins interval. All participants will be followed 21 days after each immunization. Total follow up is 60 day.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Age 18-49 years old
  • Having Thai ID card or equivalent
  • Are seronegative to the specific H5 influenza virus determined by antibody titer less than 1:40 by HAI test to the corresponding antigen.
  • Anti HIV - Negative
  • All hematology & biochemistry and urine analysis are within normal range or of no clinical significance (not more than 1.5 times of normal value)
  • Able to read and write and sign written informed consent.

Exclusion Criteria:

  • Known history of egg allergy
  • Having had recently influenza infection confirmed as H5
  • History of bronchial asthma
  • History of chronic lung diseases
  • History of chronic rhinitis
  • History of immunodeficiency state
  • History of immunosuppression
  • History of heavy smoking (more than 5 rolls per day)
  • History of alcoholic (pure drink 200 ml per day)
  • Acute infectious and noninfectious diseases (within 2 weeks)
  • Exacerbation of chronic diseases or cancer or HIV positives
  • Anamnestic leukocytosis, hepatitis B and C positives
  • The volunteers who have been taking immunoglobulin products or have had a blood transfusion during past three months before the beginning of the experiment
  • Participation in other research study or stop participant less than 1 month
  • Pregnancy or plan to become pregnant for 60 days after enrollment or breast feeding
  • Any concomitant medication with Aspirin
  • The volunteers who have family members with immunodeficiency
  • Poultry workers
  • Have undertaken international travel within the one week prior to immunization
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656356

Locations
Thailand
Faculty of Tropical Medicine
Bangkok, Thailand, 10400
Sponsors and Collaborators
Mahidol University
  More Information

No publications provided

Responsible Party: Punnee Pitisuttithum, Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01656356     History of Changes
Other Study ID Numbers: GPO AVIAN FLU Vaccine-V02
Study First Received: July 25, 2012
Last Updated: August 7, 2012
Health Authority: Thailand: Ethical Committee
Thailand: Food and Drug Administration

Keywords provided by Mahidol University:
Avian Flu
H5N2

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

ClinicalTrials.gov processed this record on May 16, 2013