Phase I/II Safety and Immunogenicity of Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1) in Healthy Thais

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: Vaccine A/17/CA/2009/38 (H1N1)

• Registration Number: NCT01666262
• Lead Sponsor: Mahidol University

Brief Summary

The purpose of this study is to evaluate safety and reactogenicity of Pandemic Live Attenuated Influenza Vaccine (PLAIV) manufactured by GPO, Thailand, and to evaluate humoral immune response of the above vaccine after intranasal application by using HAI test, micro neutralization assays.

Detailed Description

Part A: 24 volunteers will be enrolled and divided into 2 groups -12 volunteers in each of 2 groups receiving either 5.0-6.5 log 10 EID50 or 6.6-7.5 log10 EID50 respectively. 9 who will received vaccine vaccine strain and 3 who will received placebo.

Part B: Total 324 participants will randomized into 2 group using 3:1 ratio (300 vaccines:100 placebos). There are 3 stratified age groups: \>12-18 years, \>18-49 years and \>49 years.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-01-11
• Study Completion: 2012-01
• Status Verified: 2012-08
• Study First Submitted QC: 2012-08-10
• Last Update Submitted: 2012-08-10
• Study First Posted: 2012-08-16
• Last Update Posted: 2012-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 363

Inclusion Criteria

• Healthy
• Age 9 - >49 years old
• Having Thai ID card or equivalent
• Are seronegative to the specific H1N1 influenza virus determined by antibody titer less than 1:10 by HAI test to the corresponding antigen
• Anti HIV - Negative
• All hematology & biochemistry within normal range
• Able to read and write and sign written informed consent

Exclusion Criteria

• Known history of egg allergy
• Having had recently influenza infection confirmed as H1N1 (indeed all other types if Influenza and vaccination with seasonal vaccine will not interfere)
• History of bronchial asthma
• History of chronic lung diseases
• History of chronic rhinitis
• History of immunodeficiency state
• History of immunosuppression
• Acute infectious and noninfectious diseases (within 2 weeks)
• Exacerbation of chronic diseases or cancer or HIV positives
• Anamnestic leukocytosis, hepatitis B and C 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
• Pregnancy or plan to become pregnant for 60 days after enrollment or breast feeding
• Any concomitant medication with Aspirin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A/17/CA/2009/38 (H1N1)	Vaccine A/17/CA/2009/38 (H1N1)	-

Primary Outcome Measures

Name	Time	Method
Systemic reaction and local reaction (vital sign, temperature)	11/2 year

Secondary Outcome Measures

Name	Time	Method
Humoral immune response	11/2 year	Peak immunogenicity blood specimen and nasal washing for accessing immune response IgA.; Nasal swab on D2, D3, D5, D7 after immunization. Blood for ASC assay at D0 (baseline) and D7 after each dose of vaccine.

Trial Locations

Locations (1)

Faculty of Tropical Medicine, Mahidol University; 🇹🇭 Bangkok, Thailand