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

Phase 1

Completed

• Conditions: Crimean-Congo Hemorrhagic Fever
• Interventions: Biological: KIRIM-KONGO-VAX; Other: Placebo

• Registration Number: NCT03020771
• Lead Sponsor: The Scientific and Technological Research Council of Turkey

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-13
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-16
• Last Update Posted: 2017-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5 mcg IM	KIRIM-KONGO-VAX	-
5 mcg SC control	Placebo	0.9% NaCl Solution
10 mcg IM	KIRIM-KONGO-VAX	-
5 mcg SC	KIRIM-KONGO-VAX	-
5 mcg IM control	Placebo	0.9% NaCl Solution
10 mcg SC	KIRIM-KONGO-VAX	-

Primary Outcome Measures

Name	Time	Method
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.	One year follow up	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.

Secondary Outcome Measures

Name	Time	Method
Immunogenicity	One year follow up	This secondary outcome will be performed at every humoral and cellular level after each immunization, based on immunological responses.