Evaluation of Pandemic Influenza A (H1N1)Candidate Vaccines

This study has been completed.
Sponsor:
Collaborators:
Hospital Universitario da USP
Instituto da Criança do Hospital das Clínicas da Faculdade de Medicina da USP
Information provided by (Responsible Party):
Butantan Institute
ClinicalTrials.gov Identifier:
NCT01111968
First received: April 14, 2010
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

This is a prospective phase I study to evaluate the safety, tolerability and immunogenicity of nine adjuvanted candidate vaccines against pandemic influenza A (H1N1) virus.


Condition Intervention Phase
Influenza
Biological: pandemic vaccine 1
Biological: pandemic vaccine 2
Biological: pandemic vaccine 5
Biological: pandemic vaccine 6
Biological: pandemic vaccine 9
Biological: pandemic vaccine 10
Biological: pandmeic vaccine 11
Biological: pandmeic vaccine 12
Biological: pandmic vaccine 13
Biological: placebo group 14
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Safety, Tolerability and Immunogenicity of Adjuvanted Candidate Vaccines Against Pandemic Influenza A (H1N1)

Resource links provided by NLM:


Further study details as provided by Butantan Institute:

Primary Outcome Measures:
  • the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay [ Time Frame: 21 days after each vaccination ] [ Designated as safety issue: No ]
    Volunteers will receive two doses of vaccine,21 days apart.


Secondary Outcome Measures:
  • Safety and tolerability [ Time Frame: 30 minutes and 72 hours after vaccination ] [ Designated as safety issue: Yes ]
    Evaluation of local and systemic adverse effects throught the study period


Enrollment: 266
Study Start Date: January 2010
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pandemic vaccine 1
7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
Biological: pandemic vaccine 1
7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
Other Name: vaccine group C
Experimental: pandemic vaccine 2
3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
Biological: pandemic vaccine 2
3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
Other Name: vaccine group I
Experimental: pandemic vaccine 5
7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion
Biological: pandemic vaccine 5
7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion
Other Name: vaccine group N
Experimental: pandemic vaccine 6
3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion
Biological: pandemic vaccine 6
3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion
Other Name: vaccine group A
Experimental: pandemic vaccine 9
7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
Biological: pandemic vaccine 9
7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
Other Name: vaccine group F
Experimental: pandemic vaccine 10
3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
Biological: pandemic vaccine 10
3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
Other Name: vaccine group L
Experimental: pandemic vaccine 11
7,5µg of A/H1N1 with Al(OH)3
Biological: pandmeic vaccine 11
7,5µg of A/H1N1 with Al(OH)3
Other Name: vaccine group E
Experimental: pandemic vaccine 12
3,75µg of A/H1N1 with Al(OH)3
Biological: pandmeic vaccine 12
3,75µg of A/H1N1 with Al(OH)3
Other Name: vaccine group K
Experimental: pandemic vaccine 13
15µg of A/H1N1 with no adjuvant
Biological: pandmic vaccine 13
15µg of A/H1N1 with no adjuvant
Other Name: vaccine group H
Placebo Comparator: placebo group 14
placebo
Biological: placebo group 14
All elements of the vaccine but antigen and adjuvant
Other Name: vaccine group B

Detailed Description:

The candidate vaccines are produced by Butantan institute - Sao Paulo, Brazil

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Health adults of both genders
  • Age ≥ 18 ≤ 50 years
  • Able to understand every required study procedure
  • Female volunteers should agree to take an acceptable contraceptive method Menopause is characterized by absence of menstrual flux for two consective years
  • Normal values for pre-stablished laboratory assays
  • Accpetance to participate and sign the consent form

Exclusion Criteria:

  • Any chronic condition
  • Be on immunossupressive or stimulant therapy
  • Have egg alergy
  • Have past history of alergy to sazonal influenza vaccine
  • Have received another inactivated vaccine within the prior 2 weeks or a live vaccine in the past four weeks to his/her participation in the study
  • Acute infectious disease during seven days prior vaccination
  • Female on breasthfeeding
  • Confirmed prior infection by pandemic influenza A
  • Participation in another clinical trial in the last 6 months
  • Any other condition identified by the principal investigator which is considered not safe for enrollment of the volunteer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01111968

Locations
Brazil
Centro de Pesquisa Clinica do Instituto da Criança do hospital das Clinicas da Faculdade de Medicina da USP
Sao Paulo, Brazil, 05403-900
Centro de Pesquisa Clínica do Hospital Universitário da USP
Sao Paulo, Brazil, 05508000
Sponsors and Collaborators
Butantan Institute
Hospital Universitario da USP
Instituto da Criança do Hospital das Clínicas da Faculdade de Medicina da USP
Investigators
Principal Investigator: Lucia MA Campos, MD. PhD Children´s Institute - School of Medicine of University of Sao Paulo
  More Information

No publications provided by Butantan Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Butantan Institute
ClinicalTrials.gov Identifier: NCT01111968     History of Changes
Other Study ID Numbers: BUTVAC - Influenza A (H1N1)
Study First Received: April 14, 2010
Last Updated: February 5, 2013
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Butantan Institute:
vaccine
pandemic influenza A
adjuvant
safety

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014