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

NCT00778388 | Completed Phase 1 DMC

• 1 other identifier: IC43-101
• Study Type: interventional
• Target: 157
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Healthy

Keywords

Pseudomonas Aeruginosa

Outcome Measures

Primary Outcomes (4)

• immunogenicity at day 14

  see above

• rate of serious adverse events during vaccination period until 6 months after first vaccination

  see above

• safety laboratory parameters at intervals up to day 180

  see above

• systemic and local tolerability at intervals up to day 180

  see above

Secondary Outcomes (4)

• immunogenicity

  see above

• measurement of functional antibody induction

  see above

• measurement of antibody avidity on days 7 and 14

  see above

• measurement of anti-histidine antibodies on days 7, 14, 90, and 180

  see above

Study Arms (5)

IC43 50

ACTIVE COMPARATOR

IC43 50 mcg with AI(OH)3

Biological: IC43

IC43 100 with

ACTIVE COMPARATOR

IC43 100 mcg with AI(OH)3

Biological: IC43

IC43 100 w/o

ACTIVE COMPARATOR

IC43 100 mcg w/o AI(OH)3

Biological: IC43

IC43 200

ACTIVE COMPARATOR

IC43 200 mcg with AI(OH)3

Biological: IC43

Placebo

PLACEBO COMPARATOR

Placebo (0,9% NaCl)

Drug: Placebo

Interventions

IC43 BIOLOGICAL

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.

Also known as: IC43 Pseudomonas Aeruginosa

IC43 100 w/o; IC43 100 with; IC43 200; IC43 50

Placebo DRUG

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.

Also known as: NaCl

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Valneva Austria GmbH: lead

Study Sites (3)

Univ.-Prof. Dr. Bernd Jilma

Vienna, Vienna, 1090, Austria

Location

Dr. Daniel Sehrt

Göttingen, Göttingen, Germany

Location

Dr. Jutta Harten

Münster, Münster, Germany

Location

MeSH Terms

Conditions

Pseudomonas Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Sonja Ernsthofer, Mag.

  Valneva Austria GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2008
• First Posted: October 23, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: October 19, 2012

Record last verified: 2012-10

Locations

DE (2); AU (1)