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Evaluation of Pandemic Influenza A (H1N1)Candidate Vaccines

Primary Purpose

Influenza

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
pandemic vaccine 1
pandemic vaccine 2
pandemic vaccine 5
pandemic vaccine 6
pandemic vaccine 9
pandemic vaccine 10
pandmeic vaccine 11
pandmeic vaccine 12
pandmic vaccine 13
placebo group 14
Sponsored by
Butantan Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring vaccine, pandemic influenza A, adjuvant, safety

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centro de Pesquisa Clinica do Instituto da Criança do hospital das Clinicas da Faculdade de Medicina da USP
  • Centro de Pesquisa Clínica do Hospital Universitário da USP

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

pandemic vaccine 1

pandemic vaccine 2

pandemic vaccine 5

pandemic vaccine 6

pandemic vaccine 9

pandemic vaccine 10

pandemic vaccine 11

pandemic vaccine 12

pandemic vaccine 13

placebo group 14

Arm Description

7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3

3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3

7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion

3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion

7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion

3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion

7,5µg of A/H1N1 with Al(OH)3

3,75µg of A/H1N1 with Al(OH)3

15µg of A/H1N1 with no adjuvant

placebo

Outcomes

Primary Outcome Measures

the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay
Volunteers will receive two doses of vaccine,21 days apart.

Secondary Outcome Measures

Safety and tolerability
Evaluation of local and systemic adverse effects throught the study period

Full Information

First Posted
April 14, 2010
Last Updated
February 5, 2013
Sponsor
Butantan Institute
Collaborators
Hospital Universitario da USP, University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01111968
Brief Title
Evaluation of Pandemic Influenza A (H1N1)Candidate Vaccines
Official Title
Evaluation of Safety, Tolerability and Immunogenicity of Adjuvanted Candidate Vaccines Against Pandemic Influenza A (H1N1)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Butantan Institute
Collaborators
Hospital Universitario da USP, University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
The candidate vaccines are produced by Butantan institute - Sao Paulo, Brazil

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
vaccine, pandemic influenza A, adjuvant, safety

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
266 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pandemic vaccine 1
Arm Type
Experimental
Arm Description
7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
Arm Title
pandemic vaccine 2
Arm Type
Experimental
Arm Description
3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
Arm Title
pandemic vaccine 5
Arm Type
Experimental
Arm Description
7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion
Arm Title
pandemic vaccine 6
Arm Type
Experimental
Arm Description
3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion
Arm Title
pandemic vaccine 9
Arm Type
Experimental
Arm Description
7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
Arm Title
pandemic vaccine 10
Arm Type
Experimental
Arm Description
3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
Arm Title
pandemic vaccine 11
Arm Type
Experimental
Arm Description
7,5µg of A/H1N1 with Al(OH)3
Arm Title
pandemic vaccine 12
Arm Type
Experimental
Arm Description
3,75µg of A/H1N1 with Al(OH)3
Arm Title
pandemic vaccine 13
Arm Type
Experimental
Arm Description
15µg of A/H1N1 with no adjuvant
Arm Title
placebo group 14
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Biological
Intervention Name(s)
pandemic vaccine 1
Other Intervention Name(s)
vaccine group C
Intervention Description
7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
Intervention Type
Biological
Intervention Name(s)
pandemic vaccine 2
Other Intervention Name(s)
vaccine group I
Intervention Description
3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
Intervention Type
Biological
Intervention Name(s)
pandemic vaccine 5
Other Intervention Name(s)
vaccine group N
Intervention Description
7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion
Intervention Type
Biological
Intervention Name(s)
pandemic vaccine 6
Other Intervention Name(s)
vaccine group A
Intervention Description
3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion
Intervention Type
Biological
Intervention Name(s)
pandemic vaccine 9
Other Intervention Name(s)
vaccine group F
Intervention Description
7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
Intervention Type
Biological
Intervention Name(s)
pandemic vaccine 10
Other Intervention Name(s)
vaccine group L
Intervention Description
3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
Intervention Type
Biological
Intervention Name(s)
pandmeic vaccine 11
Other Intervention Name(s)
vaccine group E
Intervention Description
7,5µg of A/H1N1 with Al(OH)3
Intervention Type
Biological
Intervention Name(s)
pandmeic vaccine 12
Other Intervention Name(s)
vaccine group K
Intervention Description
3,75µg of A/H1N1 with Al(OH)3
Intervention Type
Biological
Intervention Name(s)
pandmic vaccine 13
Other Intervention Name(s)
vaccine group H
Intervention Description
15µg of A/H1N1 with no adjuvant
Intervention Type
Biological
Intervention Name(s)
placebo group 14
Other Intervention Name(s)
vaccine group B
Intervention Description
All elements of the vaccine but antigen and adjuvant
Primary Outcome Measure Information:
Title
the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay
Description
Volunteers will receive two doses of vaccine,21 days apart.
Time Frame
21 days after each vaccination
Secondary Outcome Measure Information:
Title
Safety and tolerability
Description
Evaluation of local and systemic adverse effects throught the study period
Time Frame
30 minutes and 72 hours after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucia MA Campos, MD. PhD
Organizational Affiliation
Children´s Institute - School of Medicine of University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Pesquisa Clinica do Instituto da Criança do hospital das Clinicas da Faculdade de Medicina da USP
City
Sao Paulo
ZIP/Postal Code
05403-900
Country
Brazil
Facility Name
Centro de Pesquisa Clínica do Hospital Universitário da USP
City
Sao Paulo
ZIP/Postal Code
05508000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
21945258
Citation
Precioso AR, Miraglia JL, Campos LM, Goulart AC, Timenetsky Mdo C, Cardoso MR, Luna E, Mondini G, Guedes Jda S, Raw I. A phase I randomized, double-blind, controlled trial of 2009 influenza A (H1N1) inactivated monovalent vaccines with different adjuvant systems. Vaccine. 2011 Nov 8;29(48):8974-81. doi: 10.1016/j.vaccine.2011.09.040. Epub 2011 Sep 21.
Results Reference
derived

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Evaluation of Pandemic Influenza A (H1N1)Candidate Vaccines

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