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

Mahidol University

Status and phase

Completed

Phase 2

Phase 1

Conditions

Healthy

Treatments

Other: Placebo:Stabilizer

Biological: Vaccine A/17/CA/2009/38 (H1N1)

Study type

Interventional

Funder types

Other

Identifiers

NCT01666262

GPO FLU VACCINE-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

363 patients

Sex

All

Ages

9 to 65 years old

Volunteers

Accepts Healthy Volunteers

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