Phase I Study to Evaluate Basic Pharmacodynamic, Pharmacological and Toxicological Effects of the Newly Developed Crimean-Congo Hemorrhagic Fever Vaccine for Humans
October 16, 2017 updated by: Aydin Erenmemisoglu, The Scientific and Technological Research Council of Turkey
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 5 mcg IM
|
Crimean-Congo Hemorrhagic Fever Vaccine
|
|
Active Comparator: 5 mcg SC
|
Crimean-Congo Hemorrhagic Fever Vaccine
|
|
Placebo Comparator: 5 mcg IM control
0.9% NaCl Solution
|
|
|
Placebo Comparator: 5 mcg SC control
0.9% NaCl Solution
|
|
|
Active Comparator: 10 mcg IM
|
Crimean-Congo Hemorrhagic Fever Vaccine
|
|
Active Comparator: 10 mcg SC
|
Crimean-Congo Hemorrhagic Fever Vaccine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
One year follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
One year follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Aydın Erenmemisoglu, MD PhD, TC Erciyes University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2014
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
January 11, 2017
First Submitted That Met QC Criteria
January 12, 2017
First Posted (Estimate)
January 13, 2017
Study Record Updates
Last Update Posted (Actual)
October 17, 2017
Last Update Submitted That Met QC Criteria
October 16, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MON116.40.1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.