Study Assessing Safety and Immunogenicity of IC43 Vaccination Against Pseudomonas Aeruginosa in Healthy Volunteers - Full Text View

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 Intercell AG:

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

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

Intercell AG

Investigators

Study Director:

Sonja Ernsthofer, Mag.

Intercell AG

More Information

No publications provided

Responsible Party:	Intercell AG
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 Intercell AG:

Pseudomonas Aeruginosa

Additional relevant MeSH terms:

Pseudomonas Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 22, 2013