Clinical trial NCT01656356: Phase I Safety and Immunogenicity of Live Attenuated Influenza H5 Candidate Vaccine Strain A/17/Turkey/Turkey/05/133 (H5N2) in Healthy Thai Volunteers
Official title: Phase I Safety and Immunogenicity of Live Attenuated Influenza H5 Candidate Vaccine Strain A/17/Turkey/Turkey/05/133 (H5N2) in Healthy Thai Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Preventive Avian Flu
Keywords: Avian Flu
H5N2
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2012-08-03
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Tropical Medicine
Study officials:
References: