Phase I/II Safety and Immunogenicity of Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1) in Healthy Thais
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Mahidol University
- Enrollment
- 363
- Locations
- 1
- Primary Endpoint
- Systemic reaction and local reaction (vital sign, temperature)
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Punnee Pitisuttithum
Professor
Mahidol University
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Systemic reaction and local reaction (vital sign, temperature)
Time Frame: 11/2 year
Secondary Outcomes
- Humoral immune response(11/2 year)