Safety and Immunogenicity of Live Attenuated Influenza H5N2

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-06-30

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.

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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.

Conditions

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Influenza Due to Influenza A Virus Subtype H5N2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A/17/turkey/Turkey/05/133 (H5N2)

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.

Group Type EXPERIMENTAL

Avian Flu Vaccine

Intervention Type BIOLOGICAL

Placebo

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.

Group Type PLACEBO_COMPARATOR

Avian Flu Vaccine

Intervention Type BIOLOGICAL

Interventions

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Avian Flu Vaccine

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes