Evaluation of Pandemic Influenza A (H1N1)Candidate Vaccines

February 5, 2013 updated by: Butantan Institute

Evaluation of Safety, Tolerability and Immunogenicity of Adjuvanted Candidate Vaccines Against Pandemic Influenza A (H1N1)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

266

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403-900
        • Centro de Pesquisa Clinica do Instituto da Criança do hospital das Clinicas da Faculdade de Medicina da USP
      • Sao Paulo, Brazil, 05508000
        • Centro de Pesquisa Clínica do Hospital Universitário da USP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • vaccine group H
Placebo Comparator: placebo group 14
placebo
Biological: placebo group 14
All elements of the vaccine but antigen and adjuvant
Other Names:
  • vaccine group B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay
Time Frame: 21 days after each vaccination
Volunteers will receive two doses of vaccine,21 days apart.
21 days after each vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability
Time Frame: 30 minutes and 72 hours after vaccination
Evaluation of local and systemic adverse effects throught the study period
30 minutes and 72 hours after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Butantan Institute

Collaborators

University of Sao Paulo
Hospital Universitario da USP

Investigators

  • Principal Investigator: Lucia MA Campos, MD. PhD, Children´s Institute - School of Medicine of University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

April 14, 2010

First Submitted That Met QC Criteria

April 27, 2010

First Posted (Estimate)

April 28, 2010

Study Record Updates

Last Update Posted (Estimate)

February 6, 2013

Last Update Submitted That Met QC Criteria

February 5, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUTVAC - Influenza A (H1N1)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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