Safety and Immunogenicity of Live Attenuated Influenza H5N2
- Conditions
- Influenza Due to Influenza A Virus Subtype H5N2
- Registration Number
- NCT01841918
- Lead Sponsor
- Mahidol University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Faculty of Tropical Medicine
🇹🇭Bangkok, Thailand
Faculty of Tropical Medicine🇹🇭Bangkok, Thailand