Clinical trial NCT00778388: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pseudomonas Aeruginosa
Lead sponsor: Valneva Austria GmbH
Sponsor class: INDUSTRY
First posted: 2008-10-23
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: immunogenicity at day 14
timeFrame: see above
measure: rate of serious adverse events during vaccination period until 6 months after first vaccination
timeFrame: see above
measure: safety laboratory parameters at intervals up to day 180
timeFrame: see above
measure: systemic and local tolerability at intervals up to day 180
timeFrame: see above
Secondary outcomes:
measure: immunogenicity
timeFrame: see above
measure: measurement of functional antibody induction
timeFrame: see above
measure: measurement of antibody avidity on days 7 and 14
timeFrame: see above
measure: measurement of anti-histidine antibodies on days 7, 14, 90, and 180
timeFrame: see above
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Univ.-Prof. Dr. Bernd Jilma
city: Göttingen
country: Germany
facility: Dr. Daniel Sehrt
city: Münster
country: Germany
facility: Dr. Jutta Harten
Study officials:
affiliation: Valneva Austria GmbH
name: Sonja Ernsthofer, Mag.
role: STUDY_DIRECTOR
References: