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Safety and Immunogenicity of Live Attenuated Influenza H5N2

Sponsor
Mahidol University (Other)
Overall Status
Completed
CT.gov ID
NCT01841918
Collaborator
The Government Pharmaceutical Organization (Other), World Health Organization (Other)
150
Enrollment
1
Location
2
Arms
5
Duration (Months)
30.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate immune response and safety of live attenuated influenza H5 vaccine candidate strain A/17/turkey/Turkey/05/133 (H5N2) manufactured by GPO, Thailand in healthy Thais.

Condition or Disease Intervention/Treatment Phase
  • Biological: Avian Flu Vaccine
 Phase 2

Detailed Description

It is a double blind randomized study using 7.5-8.5 log EID50 dose which is the same dose as being tested in phase I.

150 participants (100 vaccinees and 50 placebos) age 18-49 years old will be enrolled. All will be separated in 4 batches; Batch 1: 36 participants (24 vaccinees and 12 placebos) Batch 2: 38 participants (25 vaccinees and 13 placebos) Batch 3: 38 participants (25 vaccinees and 13 placebos) Batch 4: 38 participants (26 vaccinees and 12 placebos)

Each batch will be admitted in the isolation ward for 5 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 28 days apart. Total follow up is 60 day.

Study Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Phase II Safety and Immunogenicity of Live Attenuated Influenza H5 Candidate Vaccine Strain A/17/Turkey/Turkey/05/133 (H5N2) in Healthy Thai Volunteers
Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
May 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: A/17/turkey/Turkey/05/133 (H5N2)

100 participants will be admitted in the isolation ward for 5 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 28 days apart and will be followed for the total of 60 days.

Biological: Avian Flu Vaccine
Placebo Comparator: Placebo

50 participants will be admitted in the isolation ward for 5 days after each administered placebo mainly for safety assessment. Two doses placebo will be given by intranasal route 28 days apart and will be followed for the total of 60 days.

Biological: Avian Flu Vaccine

Outcome Measures

Primary Outcome Measures

  1. Phase II safety and immunogenicity of live attenuated influenza H5 candidate vaccine strain A/17/turkey/Turkey/05/133 (H5N2) in healthy Thai volunteers [within 60 days after screening]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 49 Years
Sexes Eligible for Study:
All
Accepts 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

  • Poultry workers

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Tropical Medicine Bangkok Thailand 10400

Sponsors and Collaborators

  • Mahidol University
  • The Government Pharmaceutical Organization
  • World Health Organization

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Punnee Pitisuttithum, Professor, Mahidol University
ClinicalTrials.gov Identifier:
NCT01841918
Other Study ID Numbers:
  • GPO AVIAN FLU Vaccine-V02-2
First Posted:
Apr 29, 2013
Last Update Posted:
Jan 31, 2018
Last Verified:
Jul 1, 2017
Additional relevant MeSH terms:
Influenza, Human

Study Results

No Results Posted as of Jan 31, 2018