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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

Primary Purpose

Crimean-Congo Hemorrhagic Fever

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

KIRIM-KONGO-VAX

Placebo

About this trial

This is an interventional prevention trial for Crimean-Congo Hemorrhagic Fever focused on measuring Crimean-congo hemorrhagic fever, vaccine, human, phase I

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

5 mcg IM

5 mcg SC

5 mcg IM control

5 mcg SC control

10 mcg IM

10 mcg SC

Arm Description

0.9% NaCl Solution

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Immunogenicity

This secondary outcome will be performed at every humoral and cellular level after each immunization, based on immunological responses.

Full Information

NCT ID

NCT03020771

First Posted

January 11, 2017

Last Updated

October 16, 2017

Sponsor

The Scientific and Technological Research Council of Turkey

Collaborators

MonitorCRO

1. Study Identification

Unique Protocol Identification Number

NCT03020771

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

December 2014 (Actual)

Primary Completion Date

June 2017 (Actual)

Study Completion Date

June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Scientific and Technological Research Council of Turkey

Collaborators

MonitorCRO

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crimean-Congo Hemorrhagic Fever

Keywords

Crimean-congo hemorrhagic fever, vaccine, human, phase I

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

5 mcg IM

Arm Type

Active Comparator

Arm Title

5 mcg SC

Arm Type

Active Comparator

Arm Title

5 mcg IM control

Arm Type

Placebo Comparator

Arm Description

0.9% NaCl Solution

Arm Title

5 mcg SC control

Arm Type

Placebo Comparator

Arm Description

0.9% NaCl Solution

Arm Title

10 mcg IM

Arm Type

Active Comparator

Arm Title

10 mcg SC

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

KIRIM-KONGO-VAX

Intervention Description

Crimean-Congo Hemorrhagic Fever Vaccine

Intervention Type

Other

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

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.

Description

Time Frame

One year follow up

Secondary Outcome Measure Information:

Title

Immunogenicity

Description

This secondary outcome will be performed at every humoral and cellular level after each immunization, based on immunological responses.

Time Frame

One year follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aydın Erenmemisoglu, MD PhD

Organizational Affiliation

TC Erciyes University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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