Phase I Study to Evaluate Basic Pharmacodynamic, Pharmacological and Toxicological Effects of the Newly Developed Crimean-Congo Hemorrhagic Fever Vaccine for Humans

Study Overview
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Brief Summary
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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.

Official Title
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Phase I Study to Evaluate Basic Pharmacodynamic, Pharmacological and Toxicological Effects of the Newly Developed Crimean-Congo Hemorrhagic Fever Vaccine for Humans, Prepared in Cell Culture and Inactivated With Formalin, and Administered Subcutaneously or Intramuscularly With Two Different Doses

Conditions
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Crimean-Congo Hemorrhagic Fever

Intervention / Treatment
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* Biological: KIRIM-KONGO-VAX
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, white in the 18-55 age range, men and/or women who agree not to become pregnant until 2 months after the start of the last vaccination Body weights are at limits to exclude anorexia or obesity (The BMI limits accepted for this study are 18.5-30 kg /m2) According to clinical and standard laboratory tests, physical and spiritually healthy volunteers. Exclusion Criteria: The 20 days before the study any vaccination applied volunteers Persons with clinically significant liver, kidney, gastrointestinal, cardiovascular, psychiatric, pulmonary, hematologic, endocrinological, or other significant acute or chronic abnormalities in the medical history of the volunteer or in the examination. Volunteers who have previously had any pulmonary infection or have previously used immunosuppressive drugs (including corticosteroids) for any reason

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 5 mcg IM<br> | Biological: KIRIM-KONGO-VAX<br>* Crimean-Congo Hemorrhagic Fever Vaccine<br>|
| Active Comparator: 5 mcg SC<br> | Biological: KIRIM-KONGO-VAX<br>* Crimean-Congo Hemorrhagic Fever Vaccine<br>|
| Placebo Comparator: 5 mcg IM control<br>0.9% NaCl Solution | Other: Placebo<br> <br> |
| Placebo Comparator: 5 mcg SC control<br>0.9% NaCl Solution | Other: Placebo<br> <br> |
| Active Comparator: 10 mcg IM<br> | Biological: KIRIM-KONGO-VAX<br>* Crimean-Congo Hemorrhagic Fever Vaccine<br>|
| Active Comparator: 10 mcg SC<br> | Biological: KIRIM-KONGO-VAX<br>* Crimean-Congo Hemorrhagic Fever Vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crimean-congo hemorrhagic fever, vaccine, human, phase I