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

Primary Purpose

Preventive Avian Flu

Status
Completed
Phase
Phase 1
Locations
Thailand
Study Type
Interventional
Intervention
Avian Flu Vaccine
Placebo
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Preventive Avian Flu focused on measuring Avian Flu, H5N2

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Faculty of Tropical Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A/17/turkey/Turkey/05/133 (H5N2)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 25, 2012
Last Updated
August 7, 2012
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT01656356
Brief 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
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

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preventive Avian Flu
Keywords
Avian Flu, H5N2

7. Study Design

Study Phase
Phase 1

8. Arms, Groups, and Interventions

Arm Title
A/17/turkey/Turkey/05/133 (H5N2)
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Avian Flu Vaccine
Intervention Type
Biological
Intervention Name(s)
Placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Faculty of Tropical Medicine
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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