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

Avian Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02229357
• Other study ID #: GPO Avian Flu Vaccine-Boost
• Status: Completed
• Phase: Phase 2
• First received: August 28, 2014
• Last updated: April 8, 2015
• Start date: June 2014
• Est. completion date: September 2014

Study information

• Verified date: April 2015
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical CommitteeThailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Avian Influenza

Intervention

Biological:
• OrniFlu® inactivated vaccine
All subjects will receive a single dose of an H5 inactivated influenza vaccine after blood collection for immunology assays

Locations

Country	Name	City	State
Thailand	Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University	Bangkok

Sponsors (3)

Lead Sponsor	Collaborator
Mahidol University	The Government Pharmaceutical Organization, World Health Organization

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects exhibiting sero-responses in each of the assays (HAI, microneutralization) in the prime-boost and the control groups.		12 Months	Yes
Secondary	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	Yes