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

Healthy Clinical Trial

Official title:

Against Pseudomonas Aeruginosa in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00778388
• Other study ID #: IC43-101
• Status: Completed
• Phase: Phase 1
• First received: October 22, 2008
• Last updated: October 18, 2012
• Start date: September 2008
• Est. completion date: September 2009

Study information

• Verified date: October 2012
• Source: Valneva Austria GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyGermany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy
• Pseudomonas Infections

Intervention

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.

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.

Locations

Country	Name	City	State
Austria	Univ.-Prof. Dr. Bernd Jilma	Vienna
Germany	Dr. Daniel Sehrt	Göttingen
Germany	Dr. Jutta Harten	Münster

Sponsors (1)

Lead Sponsor	Collaborator
Valneva Austria GmbH

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	immunogenicity at day 14		see above	Yes
Primary	rate of serious adverse events during vaccination period until 6 months after first vaccination		see above	Yes
Primary	safety laboratory parameters at intervals up to day 180		see above	Yes
Primary	systemic and local tolerability at intervals up to day 180		see above	Yes
Secondary	immunogenicity		see above	Yes
Secondary	measurement of functional antibody induction		see above	Yes
Secondary	measurement of antibody avidity on days 7 and 14		see above	Yes
Secondary	measurement of anti-histidine antibodies on days 7, 14, 90, and 180		see above	Yes