Safety and Immunogenicity of Live Attenuated Influenza H5N2
Influenza Due to Influenza A Virus Subtype H5N2
About this trial
This is an interventional prevention trial for Influenza Due to Influenza A Virus Subtype H5N2
Eligibility 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
- Poultry workers
Sites / Locations
- Faculty of Tropical Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
A/17/turkey/Turkey/05/133 (H5N2)
Placebo
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.
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.