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 ]

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.


Original Primary Outcome: Safety (adverse events) [ 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.


Current Secondary Outcome: Immunogenicity [ Time Frame: One year follow up ]

This secondary outcome will be performed at every humoral and cellular level after each immunization, based on immunological responses.


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