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Completed

NCT Number: NCT00778388

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

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

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Key information

Conditions

Healthy Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Pseudomonas Infections

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Univ.-Prof. Dr. Bernd Jilma, Vienna, State of Vienna, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: IC43 Pseudomonas Aeruginosa

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.

Other names: NaCl

Primary outcomes

  1. immunogenicity at day 14

    Time frame: see above

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

    Time frame: see above

  3. safety laboratory parameters at intervals up to day 180

    Time frame: see above

  4. systemic and local tolerability at intervals up to day 180

    Time frame: see above

Secondary outcomes

  1. immunogenicity

    Time frame: see above

  2. measurement of functional antibody induction

    Time frame: see above

  3. measurement of antibody avidity on days 7 and 14

    Time frame: see above

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

    Time frame: see above

Sponsors and collaborators

Lead sponsor

Valneva Austria GmbH

Industry

Registry information

Official study title

Against Pseudomonas Aeruginosa in Healthy Volunteers

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 23, 2008
Registry last updated
Oct 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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