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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH
ClinicalTrials.gov Identifier:
NCT00778388
First received: October 22, 2008
Last updated: October 18, 2012
Last verified: October 2012
  Purpose

The objective is to confirm the optimal dose of IC43 in regard to immunogenicity, safety and tolerability.


Condition Intervention Phase
Healthy
Biological: IC43
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Against Pseudomonas Aeruginosa in Healthy Volunteers

Further study details as provided by Valneva Austria GmbH:

Primary Outcome Measures:
  • immunogenicity at day 14 [ Time Frame: see above ] [ Designated as safety issue: Yes ]
  • rate of serious adverse events during vaccination period until 6 months after first vaccination [ Time Frame: see above ] [ Designated as safety issue: Yes ]
  • safety laboratory parameters at intervals up to day 180 [ Time Frame: see above ] [ Designated as safety issue: Yes ]
  • systemic and local tolerability at intervals up to day 180 [ Time Frame: see above ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • immunogenicity [ Time Frame: see above ] [ Designated as safety issue: Yes ]
  • measurement of functional antibody induction [ Time Frame: see above ] [ Designated as safety issue: Yes ]
  • measurement of antibody avidity on days 7 and 14 [ Time Frame: see above ] [ Designated as safety issue: Yes ]
  • measurement of anti-histidine antibodies on days 7, 14, 90, and 180 [ Time Frame: see above ] [ Designated as safety issue: Yes ]

Enrollment: 157
Study Start Date: September 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IC43 50
IC43 50 mcg with AI(OH)3
Biological: IC43
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.
Other Name: IC43 Pseudomonas Aeruginosa
Active Comparator: IC43 100 with
IC43 100 mcg with AI(OH)3
Biological: IC43
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.
Other Name: IC43 Pseudomonas Aeruginosa
Active Comparator: IC43 100 w/o
IC43 100 mcg w/o AI(OH)3
Biological: IC43
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.
Other Name: IC43 Pseudomonas Aeruginosa
Active Comparator: IC43 200
IC43 200 mcg with AI(OH)3
Biological: IC43
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.
Other Name: IC43 Pseudomonas Aeruginosa
Placebo Comparator: Placebo
Placebo (0,9% NaCl)
Drug: Placebo
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.
Other Name: NaCl

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  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: NCT00778388

Locations
Austria
Univ.-Prof. Dr. Bernd Jilma
Vienna, Austria, 1090
Germany
Dr. Daniel Sehrt
Göttingen, Germany
Dr. Jutta Harten
Münster, Germany
Sponsors and Collaborators
Valneva Austria GmbH
Investigators
Study Director: Sonja Ernsthofer, Mag. Valneva Austria GmbH
  More Information

No publications provided

Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT00778388     History of Changes
Other Study ID Numbers: IC43-101
Study First Received: October 22, 2008
Last Updated: October 18, 2012
Health Authority: Austria: Agency for Health and Food Safety
Germany: Paul-Ehrlich-Institut

Keywords provided by Valneva Austria GmbH:
Pseudomonas Aeruginosa

Additional relevant MeSH terms:
Pseudomonas Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 18, 2014