---
title: 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
overall_status: COMPLETED
phase: PHASE1
sponsor: The Scientific and Technological Research Council of Turkey
study_type: INTERVENTIONAL
primary_condition: Crimean-Congo Hemorrhagic Fever
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03020771.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03020771"
ct_last_update_post_date: 2017-10-17
last_seen_at: "2026-05-12T06:34:12.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT03020771](https://clinicaltrials.gov/study/NCT03020771)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** The Scientific and Technological Research Council of Turkey
- **Collaborators:** MonitorCRO
- **Conditions:** Crimean-Congo Hemorrhagic Fever
- **Start Date:** 2014-12
- **Completion Date:** 2017-06
- **CT.gov Last Update:** 2017-10-17

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 55 Years
- **Sex:** ALL
- **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
```

## Arms

- **5 mcg IM** (ACTIVE_COMPARATOR)
- **5 mcg SC** (ACTIVE_COMPARATOR)
- **5 mcg IM control** (PLACEBO_COMPARATOR) — 0.9% NaCl Solution
- **5 mcg SC control** (PLACEBO_COMPARATOR) — 0.9% NaCl Solution
- **10 mcg IM** (ACTIVE_COMPARATOR)
- **10 mcg SC** (ACTIVE_COMPARATOR)

## Interventions

- **KIRIM-KONGO-VAX** (BIOLOGICAL) — Crimean-Congo Hemorrhagic Fever Vaccine
- **Placebo** (OTHER)

## Primary Outcomes

- **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.** _(time frame: 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 Outcomes

- **Immunogenicity** _(time frame: One year follow up)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03020771.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03020771*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*