Preventive Avian Flu
Conditions
Keywords
Avian Flu, H5N2
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.
Interventions
BIOLOGICALAvian Flu Vaccine
BIOLOGICALPlacebo
Sponsors
Mahidol University
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
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) * 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
Countries
Thailand
Outcome results
None listed