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Safety and Immunogenicity of Live Attenuated Influenza H5N2

Primary Purpose

Influenza Due to Influenza A Virus Subtype H5N2

Status

Completed

Phase

Phase 2

Locations

Thailand

Study Type

Interventional

Intervention

Avian Flu Vaccine

About this trial

This is an interventional prevention trial for Influenza Due to Influenza A Virus Subtype 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
Poultry workers

Sites / Locations

Faculty of Tropical Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

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

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Phase II safety and immunogenicity of live attenuated influenza H5 candidate vaccine strain A/17/turkey/Turkey/05/133 (H5N2) in healthy Thai volunteers

Secondary Outcome Measures

Full Information

NCT ID

NCT01841918

First Posted

January 29, 2013

Last Updated

January 30, 2018

Sponsor

Mahidol University

Collaborators

The Government Pharmaceutical Organization, World Health Organization

1. Study Identification

Unique Protocol Identification Number

NCT01841918

Brief Title

Safety and Immunogenicity of Live Attenuated Influenza H5N2

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 Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mahidol University

Collaborators

The Government Pharmaceutical Organization, World Health Organization

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza Due to Influenza A Virus Subtype H5N2

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Avian Flu Vaccine

Primary Outcome Measure Information:

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

Time Frame

within 60 days after screening

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

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 Poultry workers

Facility Information:

Facility Name

Faculty of Tropical Medicine

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

28533093

Citation

Pitisuttithum P, Boonnak K, Chamnanchanunt S, Puthavathana P, Luvira V, Lerdsamran H, Kaewkungwal J, Lawpoolsri S, Thanachartwet V, Silachamroon U, Masamae W, Schuetz A, Wirachwong P, Thirapakpoomanunt S, Rudenko L, Sparrow E, Friede M, Kieny MP. Safety and immunogenicity of a live attenuated influenza H5 candidate vaccine strain A/17/turkey/Turkey/05/133 H5N2 and its priming effects for potential pre-pandemic use: a randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2017 Aug;17(8):833-842. doi: 10.1016/S1473-3099(17)30240-2. Epub 2017 May 19.

Results Reference

derived

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Safety and Immunogenicity of Live Attenuated Influenza H5N2

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