Safety and Immunogenicity of Live Attenuated Influenza H5N2

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

Detailed Description
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It is a double blind randomized study using 7.5-8.5 log EID50 dose which is the same dose as being tested in phase I. 150 participants (100 vaccinees and 50 placebos) age 18-49 years old will be enrolled. All will be separated in 4 batches; Batch 1: 36 participants (24 vaccinees and 12 placebos) Batch 2: 38 participants (25 vaccinees and 13 placebos) Batch 3: 38 participants (25 vaccinees and 13 placebos) Batch 4: 38 participants (26 vaccinees and 12 placebos) Each batch will be admitted in the isolation ward for 5 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 28 days apart. Total follow up is 60 day.

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

Conditions
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Influenza Due to Influenza A Virus Subtype H5N2

Intervention / Treatment
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* Biological: Avian Flu Vaccine


Participation Criteria
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Eligibility Criteria
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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 Poultry workers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A/17/turkey/Turkey/05/133 (H5N2)<br>100 participants will be admitted in the isolation ward for 5 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 28 days apart and will be followed for the total of 60 days. | Biological: Avian Flu Vaccine<br> <br> |
| Placebo Comparator: Placebo<br>50 participants will be admitted in the isolation ward for 5 days after each administered placebo mainly for safety assessment. Two doses placebo will be given by intranasal route 28 days apart and will be followed for the total of 60 days. | Biological: Avian Flu Vaccine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase II safety and immunogenicity of live attenuated influenza H5 candidate vaccine strain A/17/turkey/Turkey/05/133 (H5N2) in healthy Thai volunteers |  | within 60 days after screening |