Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| MonitorCRO | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study covers the first trial of the Crimean-Congo Hemorrhagic fever virus (CKKA) vaccine on humans (healthy volunteers), which has been developed in Turkey and has completed preclinical toxicology studies to be performed on experimental animals. Also, this study is a Phase I, randomized, double-blind, national, single-center, placebo-controlled study that is designed to evaluate the safety and efficacy of the CKKA vaccine. A total of 60 (12 + 48) healthy male and/or female volunteers will be participating in this study, and the study is planned to last approximately one year.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 mcg IM | Active Comparator |
| |
| 5 mcg SC | Active Comparator |
| |
| 5 mcg IM control | Placebo Comparator | 0.9% NaCl Solution |
|
| 5 mcg SC control | Placebo Comparator | 0.9% NaCl Solution |
|
| 10 mcg IM | Active Comparator |
| |
| 10 mcg SC | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KIRIM-KONGO-VAX | Biological | Crimean-Congo Hemorrhagic Fever Vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the IMP in terms of number and frequency of any adverse events, any abnormal findings in physical examinations, ECGs, and laboratory parameters occurred during the follow up period. | The safety parameters planned for this experimental vaccine will be all adverse events experienced by the volunteers or not identified by the volunteer and identified resulting from physical examinations or laboratory tests or ECG by the investigators. | One year follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | This secondary outcome will be performed at every humoral and cellular level after each immunization, based on immunological responses. | One year follow up |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Aydın Erenmemisoglu, MD PhD | TC Erciyes University | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other |
|
| ID | Term |
|---|---|
| D006479 | Hemorrhagic Fever, Crimean |
| ID | Term |
|---|---|
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D017282 | Tick-Borne Diseases |
| D014777 | Virus Diseases |
| D002044 | Bunyaviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
Not provided
Not provided