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

Study Overview
=================
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.

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

Conditions
-----------------
Avian Influenza

Intervention / Treatment
-----------------
* Biological: OrniFlu® inactivated vaccine


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects exhibiting sero-responses in each of the assays (HAI, microneutralization) in the prime-boost and the control groups. |  | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 12 Month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
H5N2 Vaccine