Phase I Safety and Immunogenicity of Live Attenuated Influenza H5 Candidate Vaccine Strain A/17/Turkey/Turkey/05/133 (H5N2) in Healthy Thai Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Preventive Avian Flu
- Sponsor
- Mahidol University
- Locations
- 1
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Punnee Pitisuttithum
Professor
Mahidol University
Eligibility Criteria
Inclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified