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

Crimean-Congo Hemorrhagic Fever Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03020771
• Other study ID #: MON116.40.1
• Status: Completed
• Phase: Phase 1
• First received: January 11, 2017
• Last updated: October 16, 2017
• Start date: December 2014
• Est. completion date: June 2017

Study information

• Verified date: October 2017
• Source: Tubitak
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Crimean-Congo Hemorrhagic Fever
• Fever

Intervention

Biological:
• KIRIM-KONGO-VAX
Crimean-Congo Hemorrhagic Fever Vaccine

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Tubitak	MonitorCRO

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Immunogenicity	This secondary outcome will be performed at every humoral and cellular level after each immunization, based on immunological responses.	One year follow up