MedTrace Logo

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

NCT03020771 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-10-17

No results posted yet for this study

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

Interventions

BIOLOGICAL

KIRIM-KONGO-VAX

Crimean-Congo Hemorrhagic Fever Vaccine

OTHER

Placebo

Sponsors & Collaborators

  • MonitorCRO

    collaborator INDUSTRY

  • The Scientific and Technological Research Council of Turkey

    lead OTHER

Principal Investigators

  • Aydın Erenmemisoglu, MD PhD · TC Erciyes University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-06-30
Completion
2017-06-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03020771 on ClinicalTrials.gov