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

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 Overview

• Status: Completed
• Conditions: Crimean-Congo Hemorrhagic Fever
• Intervention / Treatment: Other: Placebo; Biological: KIRIM-KONGO-VAX

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Scientific and Technological Research Council of Turkey
• Collaborators: MonitorCRO
• Investigators: Principal Investigator: Aydın Erenmemisoglu, MD PhD, TC Erciyes University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: January 11, 2017
• First Submitted That Met QC Criteria: January 12, 2017
• First Posted (Estimate): January 13, 2017

Study Record Updates

• Last Update Posted (Actual): October 17, 2017
• Last Update Submitted That Met QC Criteria: October 16, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: vaccine; Crimean-congo hemorrhagic fever; human; phase I
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Arbovirus Infections; Vector Borne Diseases; Body Temperature Changes; Tick-Borne Diseases; Bunyaviridae Infections; Fever; Hemorrhagic Fevers, Viral; Hemorrhagic Fever, Crimean
• Other Study ID Numbers: MON116.40.1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No