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

Mahidol University

Status and phase

Completed

Phase 1

Conditions

Preventive Avian Flu

Treatments

Biological: Placebo

Biological: Avian Flu Vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT01656356

GPO AVIAN FLU Vaccine-V02

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 49 years old

Volunteers

Accepts Healthy Volunteers

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