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

Preventive Avian Flu Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01656356
• Other study ID #: GPO AVIAN FLU Vaccine-V02
• Status: Completed
• Phase: Phase 1
• First received: July 25, 2012
• Last updated: August 7, 2012
• Start date: May 2012

Study information

• Verified date: August 2012
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical CommitteeThailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Preventive Avian Flu

Intervention

Biological:
• Avian Flu Vaccine

• Placebo

Locations

Country	Name	City	State
Thailand	Faculty of Tropical Medicine	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand,