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

Phase 1

Completed

• Conditions: Preventive Avian Flu
• Interventions: Biological: Avian Flu Vaccine; Biological: Placebo

• Registration Number: NCT01656356
• Lead Sponsor: Mahidol University

Brief Summary

The purpose of this study is to evaluate safety and reactogenicity of live attenuated influenza H5 vaccine candidate strain A/17/turkey/Turkey/05/133 (H5N2) manufactured by GPO, in Thailand to previously healthy Thais.

Detailed Description

It is a phase I randomized placebo controlled trial (vaccine and placebo ratio of 2:1). A phase II study is planned to be conducted following review of results of this phase.

Phase I: It is a double blind randomized placebo controlled trial involving 24 participants age 18-49 years (16 will receive vaccines and 8 will receive placebo). All will be admitted in the isolation ward for 10-14 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 21 days apart. Each group of 4 participants will be immunized at a time at 30-60 mins interval. All participants will be followed 21 days after each immunization. Total follow up is 60 day.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-07-25
• Status Verified: 2012-08
• Primary Completion: 2012-08
• Study First Submitted QC: 2012-08-02
• Study First Posted: 2012-08-03
• Last Update Submitted: 2012-08-07
• Last Update Posted: 2012-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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
• The volunteers who have family members with immunodeficiency
• Poultry workers
• Have undertaken international travel within the one week prior to immunization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A/17/turkey/Turkey/05/133 (H5N2)	Avian Flu Vaccine	-
Placebo	Placebo	-

Trial Locations

Locations (1)

Faculty of Tropical Medicine; 🇹🇭 Bangkok, Thailand