Trial | NCT03020771  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
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.
Study Started
Dec 31
2014
Primary Completion
Jun 30
2017
Study Completion
Jun 30
2017
Last Update
Oct 17
2017

Biological KIRIM-KONGO-VAX

Crimean-Congo Hemorrhagic Fever Vaccine

Other Placebo

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

Criteria 

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
No Results Posted