search
Back to results

Evaluation of Priming Effects by PLAI Vaccine on the Subsequent Response to Inactivated H5N1 Vaccine

Primary Purpose

Avian Influenza

Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
OrniFlu® inactivated vaccine
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Avian Influenza focused on measuring H5N2 Vaccine

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participated in the Phase II study Protocol No.: GPO AVIAN FLU Vaccine-V02-2
  • Healthy
  • Age 18-49 years old
  • Having Thai ID card or equivalent
  • Anti HIV - Negative
  • All hematology, biochemistry and urine analysis are within normal range or of no clinical significance (not higher than 1.5 time of normal value without any clinical finding from history and physical examination)
  • 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
  • Receiving other vaccination against H5N1
  • History of bronchial asthma
  • History of chronic lung diseases
  • History of chronic rhinitis
  • History of immunodeficiency state
  • History of immunosuppression< 6 months prior to immunization
  • History of heavy smoking (more than 5 packs per day)
  • History of alcoholic (pure drink 200 ml per day)
  • Acute infectious and noninfectious diseases (within 2 weeks)
  • HIV 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
  • Poultry workers

Sites / Locations

  • Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OrniFlu® inactivated vaccine

Arm Description

Outcomes

Primary Outcome Measures

Proportion of subjects exhibiting sero-responses in each of the assays (HAI, microneutralization) in the prime-boost and the control groups.

Secondary Outcome Measures

Post-vaccination injection site and systemic reactogenicity and adverse events to the H5 inactivated influenza vaccine in subjects previously primed with LAIV H5N2 and in naïve subjects.

Full Information

First Posted
August 28, 2014
Last Updated
April 8, 2015
Sponsor
Mahidol University
Collaborators
The Government Pharmaceutical Organization, World Health Organization
search

1. Study Identification

Unique Protocol Identification Number
NCT02229357
Brief Title
Evaluation of Priming Effects by PLAI Vaccine on the Subsequent Response to Inactivated H5N1 Vaccine
Official Title
Evaluation of Priming Effects by Pandemic Live Attenuated Influenza Vaccine (LAIV Candidate Vaccine Strain A/17/Turkey/Turkey/05/133 (H5N2)) on the Subsequent Response to Inactivated H5N1 Vaccine in Healthy Thai Volunteers: A Non-Randomized, Open Label Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (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
This study aim to compare immunogenicity of the inactivated H5 influenza vaccine single dose between subjects previously vaccinated with LAIV H5N2 and naïve subjects
Detailed Description
It is a non-randomized, open label study to evaluate a licensed OrniFlu® inactivated vaccine (produced by Microgen Russia) which will be given to healthy adult volunteers who participated in a double blind placebo-controlled study Protocol No.: GPO AVIAN FLU Vaccine-V02-2 at Vaccine Trial Centre and Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University in February to May 2013. A total of 60 subjects, of whom 40 received two doses of LAIV H5N2 (prime-boost group), and 20 received placebo (control group) in the previous study will be asked to return to the clinic to receive a single dose of an inactivated H5 influenza vaccine. Total foloww up is 90 days.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OrniFlu® inactivated vaccine
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
OrniFlu® inactivated vaccine
Intervention Description
All subjects will receive a single dose of an H5 inactivated influenza vaccine after blood collection for immunology assays
Primary Outcome Measure Information:
Title
Proportion of subjects exhibiting sero-responses in each of the assays (HAI, microneutralization) in the prime-boost and the control groups.
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Post-vaccination injection site and systemic reactogenicity and adverse events to the H5 inactivated influenza vaccine in subjects previously primed with LAIV H5N2 and in naïve subjects.
Time Frame
12 Month

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: Participated in the Phase II study Protocol No.: GPO AVIAN FLU Vaccine-V02-2 Healthy Age 18-49 years old Having Thai ID card or equivalent Anti HIV - Negative All hematology, biochemistry and urine analysis are within normal range or of no clinical significance (not higher than 1.5 time of normal value without any clinical finding from history and physical examination) 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 Receiving other vaccination against H5N1 History of bronchial asthma History of chronic lung diseases History of chronic rhinitis History of immunodeficiency state History of immunosuppression< 6 months prior to immunization History of heavy smoking (more than 5 packs per day) History of alcoholic (pure drink 200 ml per day) Acute infectious and noninfectious diseases (within 2 weeks) HIV 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 Poultry workers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Punnee Pitisuttithum
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
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

Learn more about this trial

Evaluation of Priming Effects by PLAI Vaccine on the Subsequent Response to Inactivated H5N1 Vaccine

We'll reach out to this number within 24 hrs