Safety and Immunogenicity of Live Attenuated Influenza H5N2

Phase 2

Completed

• 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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-29
• Study First Submitted QC: 2013-04-24
• Study First Posted: 2013-04-29
• Primary Completion: 2013-05
• Study Completion: 2013-06
• Status Verified: 2017-07
• Last Update Submitted: 2018-01-30
• Last Update Posted: 2018-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

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

Trial Locations

Locations (1)

Faculty of Tropical Medicine; 🇹🇭 Bangkok, Thailand