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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03020771

Enrollment

Registered

2017-01-13

Start date

2014-12-31

Completion date

2017-06-30

Last updated

2017-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crimean-Congo Hemorrhagic Fever

Keywords

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

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.

Interventions

BIOLOGICALKIRIM-KONGO-VAX

Crimean-Congo Hemorrhagic Fever Vaccine

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026