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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004514-18 | EudraCT Number |
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The purpose of this clinical trial is to investigate the safety and tolerability of IM administered CV8102 and an IM administered combination of CV8102 and rabies vaccine in humans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CV8102 | Experimental |
| |
| Rabipur | Active Comparator |
| |
| CV8102 + Rabipur | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CV8102 | Biological | Subjects will receive 2 intramuscular doses of CV8102 given 21 days apart |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with serious and non serious adverse events | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) of CV8102 within the dose range of 25 µg to 250 µg. | Up to day 49 | |
| MTD of CV8102 in combination with rabies vaccine | Up to Day 49 | |
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Inclusion Criteria:
Exclusion Criteria:
Use of any investigational or non-registered product (adjuvant, drug) other than CV8102 within 4 weeks preceding the administration of the CV8102, or planned use of any such agent during the trial period
Subject has received any licensed or non-licensed vaccines within 4 weeks prior to the administration of CV8102 alone or in combination with the licensed rabies vaccine or planned vaccinations during the trial period
Any treatment with immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of CV8102 alone or in combination with the licensed rabies vaccine. The use of inhaled and nasal steroids, as well as topical steroids outside the vaccination area, will be permitted
Any medically diagnosed or suspected immune deficient condition based on medical history and physical examination
History of autoimmune disease or suspected autoimmune disease based on medical history and physical examination that cannot be ruled out based on further examinations
Administration of immunoglobulins (Igs) and/or any blood products within the 3 months preceding the administration of CV8102 or licensed rabies vaccine
Acute disease at the time of enrolment. Acute disease is defined as the presence of any acute condition including but not limited to non-febrile or febrile common colds, urinary tract infections, inflammatory, allergic or traumatic conditions that may interfere with safety assessment of the investigational products
Presence or evidence of significant acute or chronic disease, in particular heart disease including coronary artery disease and chronic pulmonary diseases (e.g., chronic obstructive pulmonary disease [COPD]); uncontrolled medical or psychiatric illness (subjects with uncomplicated chronic diagnoses stable and treated for ≥ 3 months e.g., mild hypertension well-controlled with medication, may be enrolled - provided the condition and its therapy are known not to be associated with an immunocompromised state or an autoimmune disease)
Major congenital defects
Known allergy to any component (or closely related substance) of the licensed rabies vaccine product
Known type I allergy to beta-lactam antibiotics
Evidence of current alcohol or drug abuse
History of any neurological disorders or seizures
Known seropositivity for human immunodeficiency virus (HIV), hepatitis B virus (HBV) (except in subjects previously vaccinated against HBV) or hepatitis C virus (HCV)
Foreseeable non-compliance with protocol as judged by the Investigator
History of any life-threatening anaphylactic reactions
Subjects with impaired coagulation in whom an IM injection is contraindicated.
Additional exclusion criteria for subjects participating in the (adjuvanted) rabies vaccination part:
Subject has previously received any investigational or licensed rabies vaccine
Intending to travel to regions/countries for which rabies vaccinations are recommended or where high risk of infection exists according to travel recommendations by the German Society of Tropical Medicine and International Health (DTG) during the trial and F/U period
Subject is taking chloroquine for malaria treatment or prophylaxis.
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| Name | Affiliation | Role |
|---|---|---|
| Ingo Meyer, MD | CRS Clinical Research Services Mönchengladbach GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Mönchengladbach GmbH | Mönchengladbach | Germany |
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| ID | Term |
|---|---|
| D011818 | Rabies |
| ID | Term |
|---|---|
| D018353 | Rhabdoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| Rabipur |
| Biological |
Subjects will receive 2 intramuscular doses of Rabipur given 21 days apart |
|
| CV8102 + Rabipur | Biological | Subjects will receive 2 intramuscular doses of CV8102+Rabipur given 21 days apart |
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| Vaccination-elicited serum rabies VNTs among the dose groups |
| Up to day 35 |
| Vaccination-elicited innate and adaptive immune responses | Evaluation of corresponding serum and blood parameters (e.g. relevant cytokines, chemokines, immune effector molecules and lymphocyte phenotyping) | Up to Day 35 |
| D007239 | Infections |