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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

Sponsor
Mahidol University (Other)
Overall Status
Completed
CT.gov ID
NCT01656356
Collaborator
(none)
1
Location
2
Arms

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Biological: Avian Flu Vaccine
  • Biological: Placebo
 Phase 1

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.

Study Design

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
Study Start Date :
May 1, 2012
Actual Primary Completion Date :
Aug 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: A/17/turkey/Turkey/05/133 (H5N2)

Biological: Avian Flu Vaccine
Placebo Comparator: Placebo

Biological: Placebo

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 49 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Faculty of Tropical Medicine Bangkok Thailand 10400

    Sponsors and Collaborators

    • Mahidol University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Punnee Pitisuttithum, Professor, Mahidol University
    ClinicalTrials.gov Identifier:
    NCT01656356
    Other Study ID Numbers:
    • GPO AVIAN FLU Vaccine-V02
    First Posted:
    Aug 3, 2012
    Last Update Posted:
    Aug 8, 2012
    Last Verified:
    Aug 1, 2012
    Keywords provided by Punnee Pitisuttithum, Professor, Mahidol University
    Avian Flu
    H5N2
    Additional relevant MeSH terms:
    Influenza in Birds

    Study Results

    No Results Posted as of Aug 8, 2012