Clinical Trial: Phase I Study to Evaluate Basic Pharmacodynamic, Pharmacological and Toxicological Effects of the Newly Developed Crimean-Congo Hemorrhagic Fever Vaccine for Humans
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Phase I Study to Evaluate Basic Pharmacodynamic, Pharmacological and Toxicological Effects of the Newly Developed Crimean-Congo Hemorrhagic Fever Vaccine for Humans, Prepa
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.
Detailed Summary:
Sponsor: Tubitak
Current Primary Outcome: 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 ]
Original Primary Outcome: Safety (adverse events) [ Time Frame: One year follow up ]
Current Secondary Outcome: Immunogenicity [ Time Frame: One year follow up ]
Original Secondary Outcome: Same as current
Information By: Tubitak
Dates:
Date Received: January 11, 2017
Date Started: December 2014
Date Completion: June 2017
Last Updated: January 13, 2017
Last Verified: January 2017