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Study Assessing Safety and Immunogenicity of IC43 Vaccination Against Pseudomonas Aeruginosa in Healthy Volunteers

Primary Purpose

Healthy

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
IC43
Placebo
Sponsored by
Valneva Austria GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy focused on measuring Pseudomonas Aeruginosa

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • written informed consent obtained prior to study entry
  • healthy adults aged between 18 and 65 years
  • no clinically relevant pathological findings in any of the investigations at the Screening visit. Minor deviations of laboratory values from the normal range may be accepted, if judged by the investigator to have no clinical relevance
  • In female subjects either childbearing potential terminated by surgery or a negative serum pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception

Exclusion Criteria:

  • History of autoimmune diseases and malignancies
  • Active or passive vaccination 4 weeks before and during the entire study protocol
  • Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
  • History of severe hypersensitivity reactions and anaphylaxis
  • Known hypersensitivity or allergic reactions to one of the components of the vaccine
  • Clinically significant diseases as judged by the investigator
  • Immunodeficiency due to immunosuppressive therapy
  • A family history of congenital or hereditary immunodeficiency

Sites / Locations

  • Univ.-Prof. Dr. Bernd Jilma
  • Dr. Daniel Sehrt
  • Dr. Jutta Harten

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

IC43 50

IC43 100 with

IC43 100 w/o

IC43 200

Placebo

Arm Description

IC43 50 mcg with AI(OH)3

IC43 100 mcg with AI(OH)3

IC43 100 mcg w/o AI(OH)3

IC43 200 mcg with AI(OH)3

Placebo (0,9% NaCl)

Outcomes

Primary Outcome Measures

immunogenicity at day 14
rate of serious adverse events during vaccination period until 6 months after first vaccination
safety laboratory parameters at intervals up to day 180
systemic and local tolerability at intervals up to day 180

Secondary Outcome Measures

immunogenicity
measurement of functional antibody induction
measurement of antibody avidity on days 7 and 14
measurement of anti-histidine antibodies on days 7, 14, 90, and 180

Full Information

First Posted
October 22, 2008
Last Updated
October 18, 2012
Sponsor
Valneva Austria GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00778388
Brief Title
Study Assessing Safety and Immunogenicity of IC43 Vaccination Against Pseudomonas Aeruginosa in Healthy Volunteers
Official Title
Against Pseudomonas Aeruginosa in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valneva Austria GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective is to confirm the optimal dose of IC43 in regard to immunogenicity, safety and tolerability.
Detailed Description
The study will be designed as a multi-center, observer-blinded, randomized, placebocontrolled phase 1 study in healthy adult subjects of 18 to 65 years of age. A total of 160 healthy male and female subjects is planned to be enrolled and randomized in five groups receiving different dosages and formulations of IC43 or placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Pseudomonas Aeruginosa

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IC43 50
Arm Type
Active Comparator
Arm Description
IC43 50 mcg with AI(OH)3
Arm Title
IC43 100 with
Arm Type
Active Comparator
Arm Description
IC43 100 mcg with AI(OH)3
Arm Title
IC43 100 w/o
Arm Type
Active Comparator
Arm Description
IC43 100 mcg w/o AI(OH)3
Arm Title
IC43 200
Arm Type
Active Comparator
Arm Description
IC43 200 mcg with AI(OH)3
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (0,9% NaCl)
Intervention Type
Biological
Intervention Name(s)
IC43
Other Intervention Name(s)
IC43 Pseudomonas Aeruginosa
Intervention Description
The study consists of a screening visit within 14 days before the administration of the investigational medicinal product (IMP), an experimental part of 180 days with seven outpatient visits on days 0, 3, 7, 14, 28, 90 and 180 and with vaccinations on days 0 and 7. IC43 vaccine will be administered intramuscularly during study visit 0 and 7 at three different doses, adjuvanted with Al(OH)3, or in one dose without Al(OH)3. Injection volumes will be 0.5 mL, 1 mL or 2 mL. Placebo will be administered intramuscularly at a dosage of 1 mL.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
NaCl
Intervention Description
The study consists of a screening visit within 14 days before the administration of the investigational medicinal product (IMP), an experimental part of 180 days with seven outpatient visits on days 0, 3, 7, 14, 28, 90 and 180 and with vaccinations on days 0 and 7. IC43 vaccine will be administered intramuscularly during study visit 0 and 7 at three different doses, adjuvanted with Al(OH)3, or in one dose without Al(OH)3. Injection volumes will be 0.5 mL, 1 mL or 2 mL. Placebo will be administered intramuscularly at a dosage of 1 mL.
Primary Outcome Measure Information:
Title
immunogenicity at day 14
Time Frame
see above
Title
rate of serious adverse events during vaccination period until 6 months after first vaccination
Time Frame
see above
Title
safety laboratory parameters at intervals up to day 180
Time Frame
see above
Title
systemic and local tolerability at intervals up to day 180
Time Frame
see above
Secondary Outcome Measure Information:
Title
immunogenicity
Time Frame
see above
Title
measurement of functional antibody induction
Time Frame
see above
Title
measurement of antibody avidity on days 7 and 14
Time Frame
see above
Title
measurement of anti-histidine antibodies on days 7, 14, 90, and 180
Time Frame
see above

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: written informed consent obtained prior to study entry healthy adults aged between 18 and 65 years no clinically relevant pathological findings in any of the investigations at the Screening visit. Minor deviations of laboratory values from the normal range may be accepted, if judged by the investigator to have no clinical relevance In female subjects either childbearing potential terminated by surgery or a negative serum pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception Exclusion Criteria: History of autoimmune diseases and malignancies Active or passive vaccination 4 weeks before and during the entire study protocol Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine History of severe hypersensitivity reactions and anaphylaxis Known hypersensitivity or allergic reactions to one of the components of the vaccine Clinically significant diseases as judged by the investigator Immunodeficiency due to immunosuppressive therapy A family history of congenital or hereditary immunodeficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonja Ernsthofer, Mag.
Organizational Affiliation
Valneva Austria GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Univ.-Prof. Dr. Bernd Jilma
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Dr. Daniel Sehrt
City
Göttingen
Country
Germany
Facility Name
Dr. Jutta Harten
City
Münster
Country
Germany

12. IPD Sharing Statement

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Study Assessing Safety and Immunogenicity of IC43 Vaccination Against Pseudomonas Aeruginosa in Healthy Volunteers

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