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Safety and Immunogenicity of Live Attenuated Influenza H5N2 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Safety and Immunogenicity of Live Attenuated Influenza H5N2

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

NCT01841918•Mahidol University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 49 years

Sex

ALL

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)
+7 more criteria

Locations (1)

Faculty of Tropical Medicine

Bangkok, Thailand

Key Dates

Start Date

January 1, 2013

Primary Completion Date

May 1, 2013

Completion Date

June 1, 2013

Last Updated

January 31, 2018

Enrollment

150

ACTUAL participants

Conditions

Influenza Due to Influenza A Virus Subtype H5N2

Interventions

Avian Flu Vaccine

BIOLOGICAL