Healthy
Conditions
Keywords
Pseudomonas Aeruginosa
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.
Interventions
BIOLOGICALIC43
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.
DRUGPlacebo
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.
Sponsors
Valneva Austria GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| systemic and local tolerability at intervals up to day 180 | see above |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Austria, Germany
Outcome results
None listed