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Safety and Immunogenicity of Live Attenuated Influenza H5N2

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ClinicalTrials.gov Identifier: NCT01841918
Recruitment Status : Completed
First Posted : April 29, 2013
Last Update Posted : January 31, 2018
Sponsor:
Collaborators:
The Government Pharmaceutical Organization
World Health Organization
Information provided by (Responsible Party):
Punnee Pitisuttithum, Mahidol University

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
Influenza Due to Influenza A Virus Subtype H5N2 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.


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Study Type : Interventional  (Clinical Trial)
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 : January 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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



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 [ Time Frame: within 60 days after screening ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • Poultry workers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841918


Locations
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Thailand
Faculty of Tropical Medicine
Bangkok, Thailand, 10400
Sponsors and Collaborators
Mahidol University
The Government Pharmaceutical Organization
World Health Organization

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Punnee Pitisuttithum, Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01841918     History of Changes
Other Study ID Numbers: GPO AVIAN FLU Vaccine-V02-2
First Posted: April 29, 2013    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: July 2017
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs