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

April 8, 2015 updated by: Punnee Pitisuttithum, Mahidol University

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

This study aim to compare immunogenicity of the inactivated H5 influenza vaccine single dose between subjects previously vaccinated with LAIV H5N2 and naïve subjects

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OrniFlu® inactivated vaccine
Biological: OrniFlu® inactivated vaccine
All subjects will receive a single dose of an H5 inactivated influenza vaccine after blood collection for immunology assays

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

World Health Organization
The Government Pharmaceutical Organization

Investigators

  • Principal Investigator: Punnee Pitisuttithum, Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

August 28, 2014

First Submitted That Met QC Criteria

August 28, 2014

First Posted (Estimate)

September 1, 2014

Study Record Updates

Last Update Posted (Estimate)

April 9, 2015

Last Update Submitted That Met QC Criteria

April 8, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPO Avian Flu Vaccine-Boost

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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