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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:
ClinicalTrials.gov Identifier:
NCT01656356
First Posted: August 3, 2012
Last Update Posted: August 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Punnee Pitisuttithum, Mahidol University
  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:


Further study details as provided by Punnee Pitisuttithum, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01656356


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

Responsible Party: Punnee Pitisuttithum, Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01656356     History of Changes
Other Study ID Numbers: GPO AVIAN FLU Vaccine-V02
First Submitted: July 25, 2012
First Posted: August 3, 2012
Last Update Posted: August 8, 2012
Last Verified: August 2012

Keywords provided by Punnee Pitisuttithum, Mahidol University:
Avian Flu
H5N2

Additional relevant MeSH terms:
Influenza in Birds
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs