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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Punnee Pitisuttithum, Mahidol University
ClinicalTrials.gov Identifier:
NCT01666262
First received: January 11, 2010
Last updated: August 10, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Healthy
Biological: Vaccine A/17/CA/2009/38 (H1N1)
Other: Placebo:Stabilizer
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Systemic reaction and local reaction (vital sign, temperature) [ Time Frame: 11/2 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Humoral immune response [ Time Frame: 11/2 year ] [ Designated as safety issue: No ]

    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.



Enrollment: 363
Study Start Date: September 2009
Study Completion Date: January 2012
Arms Assigned Interventions
Experimental: A/17/CA/2009/38 (H1N1) Biological: Vaccine A/17/CA/2009/38 (H1N1)
Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1)
Other Name: GPO Flu Vaccine-01
Placebo Comparator: Stabilizer Other: Placebo:Stabilizer
5% sucrose

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.

  Eligibility

Ages Eligible for Study:   9 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01666262

Locations
Thailand
Faculty of Tropical Medicine, Mahidol University
Bangkok, Thailand, 10400
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Prof.Punnee Pitisuttithum, MBBS,DTM&HDipGrad Mahidol University
  More Information

No publications provided

Responsible Party: Punnee Pitisuttithum, Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01666262     History of Changes
Other Study ID Numbers: GPO FLU VACCINE-01
Study First Received: January 11, 2010
Last Updated: August 10, 2012
Health Authority: Thailand: Ethical Committee
Thailand: Food and Drug Administration

Keywords provided by Mahidol University:
FLU
H1N1
GPO
PLAIV

ClinicalTrials.gov processed this record on October 20, 2014