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

Mahidol University

Status and phase

Completed

Phase 2

Conditions

Avian Influenza

Treatments

Biological: OrniFlu® inactivated vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT02229357

GPO Avian Flu Vaccine-Boost

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 49 years old

Volunteers

Accepts 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