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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

NCT ID: NCT03020771

Last Updated: 2017-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-06-30

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.

Detailed Description

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Conditions

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Crimean-Congo Hemorrhagic Fever

Keywords

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Crimean-congo hemorrhagic fever vaccine human phase I

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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5 mcg IM

Group Type ACTIVE_COMPARATOR

KIRIM-KONGO-VAX

Intervention Type BIOLOGICAL

Crimean-Congo Hemorrhagic Fever Vaccine

5 mcg SC

Group Type ACTIVE_COMPARATOR

KIRIM-KONGO-VAX

Intervention Type BIOLOGICAL

Crimean-Congo Hemorrhagic Fever Vaccine

5 mcg IM control

0.9% NaCl Solution

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

5 mcg SC control

0.9% NaCl Solution

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

10 mcg IM

Group Type ACTIVE_COMPARATOR

KIRIM-KONGO-VAX

Intervention Type BIOLOGICAL

Crimean-Congo Hemorrhagic Fever Vaccine

10 mcg SC

Group Type ACTIVE_COMPARATOR

KIRIM-KONGO-VAX

Intervention Type BIOLOGICAL

Crimean-Congo Hemorrhagic Fever Vaccine

Interventions

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KIRIM-KONGO-VAX

Crimean-Congo Hemorrhagic Fever Vaccine

Intervention Type BIOLOGICAL

Placebo

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MonitorCRO

INDUSTRY

Sponsor Role collaborator

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role lead

Responsible Party

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Aydin Erenmemisoglu

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aydın Erenmemisoglu, MD PhD

Role: PRINCIPAL_INVESTIGATOR

TC Erciyes University

Other Identifiers

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MON116.40.1

Identifier Type: -

Identifier Source: org_study_id