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

The Scientific and Technological Research Council of Turkey

Status and phase: Completed; Phase 1

Conditions: Crimean-Congo Hemorrhagic Fever

Treatments: Other: Placebo; Biological: KIRIM-KONGO-VAX

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03020771

MON116.40.1

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 6 patient groups, including a placebo group

5 mcg IM

Active Comparator group

Treatment:

Biological: KIRIM-KONGO-VAX

5 mcg SC

Active Comparator group

Treatment:

Biological: KIRIM-KONGO-VAX

5 mcg IM control

Placebo Comparator group

Description:

0.9% NaCl Solution

Treatment:

Other: Placebo

5 mcg SC control

Placebo Comparator group

Description:

0.9% NaCl Solution

Treatment:

Other: Placebo

10 mcg IM

Active Comparator group

Treatment:

Biological: KIRIM-KONGO-VAX

10 mcg SC

Active Comparator group

Treatment:

Biological: KIRIM-KONGO-VAX