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

NCT03020771 | Completed Phase 1 DMC

• 1 other identifier: MON116.40.1
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Crimean-Congo Hemorrhagic Fever

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Immunogenicity

  One year follow up

Study Arms (6)

5 mcg IM

ACTIVE COMPARATOR

Biological: KIRIM-KONGO-VAX

5 mcg SC

ACTIVE COMPARATOR

Biological: KIRIM-KONGO-VAX

5 mcg IM control

PLACEBO COMPARATOR

0.9% NaCl Solution

Other: Placebo

5 mcg SC control

PLACEBO COMPARATOR

0.9% NaCl Solution

Other: Placebo

10 mcg IM

ACTIVE COMPARATOR

Biological: KIRIM-KONGO-VAX

10 mcg SC

ACTIVE COMPARATOR

Biological: KIRIM-KONGO-VAX

Interventions

KIRIM-KONGO-VAX BIOLOGICAL

Crimean-Congo Hemorrhagic Fever Vaccine

10 mcg IM; 10 mcg SC; 5 mcg IM; 5 mcg SC

Placebo OTHER

5 mcg IM control; 5 mcg SC control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Scientific and Technological Research Council of Turkey: lead
• MonitorCRO: collaborator

MeSH Terms

Conditions

Hemorrhagic Fever, Crimean

Condition Hierarchy (Ancestors)

Arbovirus Infections; Vector Borne Diseases; Infections; Tick-Borne Diseases; Virus Diseases; Bunyaviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Study Officials

• Aydın Erenmemisoglu, MD PhD

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 13, 2017
• Study Start: December 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 17, 2017

Record last verified: 2017-10