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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01666262
• Other study ID #: GPO FLU VACCINE-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 11, 2010
• Last updated: August 10, 2012
• Start date: September 2009
• Est. completion date: January 2012

Study information

• Verified date: August 2012
• 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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• Vaccine A/17/CA/2009/38 (H1N1)
Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1)

Other:
• Placebo:Stabilizer
5% sucrose

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systemic reaction and local reaction (vital sign, temperature)		11/2 year	Yes
Secondary	Humoral immune response	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.	11/2 year	No