Crimean-Congo Hemorrhagic FeverPhase 1NCT03020771
Phase I Study to Evaluate Basic Pharmacodynamic, Pharmacological and Toxicological Effects of the Newly Developed Crimean-Congo Hemorrhagic Fever Vaccine for Humans
A Phase 1 study testing KIRIM-KONGO-VAX in people with Crimean-Congo Hemorrhagic Fever, run by The Scientific and Technological Research Council of Turkey.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Crimean-Congo Hemorrhagic Fever
- What is being tested?
- KIRIM-KONGO-VAX
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Jun 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Crimean-Congo Hemorrhagic Fever
- Being tested
- KIRIM-KONGO-VAX, Placebo
- Keywords
- Crimean-congo hemorrhagic fever, vaccine, human, phase I
- Medical subject headings
- Hemorrhagic Fever, Crimean
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KIRIM-KONGO-VAXBiological
Crimean-Congo Hemorrhagic Fever Vaccine
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| 5 mcg IM | Active comparator | Not described Receives: Biological: KIRIM-KONGO-VAX |
| 5 mcg SC | Active comparator | Not described Receives: Biological: KIRIM-KONGO-VAX |
| 5 mcg IM control | Placebo comparator | 0.9% NaCl Solution Receives: Other: Placebo |
| 5 mcg SC control | Placebo comparator | 0.9% NaCl Solution Receives: Other: Placebo |
| 10 mcg IM | Active comparator | Not described Receives: Biological: KIRIM-KONGO-VAX |
| 10 mcg SC | Active comparator | Not described Receives: Biological: KIRIM-KONGO-VAX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year follow up
Secondary outcomes (1)
Immunogenicity
This secondary outcome will be performed at every humoral and cellular level after each immunization, based on immunological responses.
Measured: One year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startDec 2014
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crimean-Congo Hemorrhagic FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Scientific and Technological Research Council of Turkey
- Sponsor type
- University, hospital or other
- Collaborators
- MonitorCRO
- Responsible party
- Principal investigator, Aydin Erenmemisoglu, The Scientific and Technological Research Council of Turkey
- Investigators
- Aydın Erenmemisoglu, MD PhD, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020771
- Sponsor's protocol ID
- MON116.40.1
- Status last verified
- Oct 2017
- First submitted
- 11 Jan 2017
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03020771
- Acronym / sponsor ID
- MON116.40.1
- Conditions
- Crimean-Congo Hemorrhagic Fever
- Keywords
- Crimean-congo hemorrhagic fever, vaccine, human, phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Scientific and Technological Research Council of TurkeyUniversity, hospital or other
- Collaborators
- MonitorCRO
- Study start
- Dec 2014 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 5 mcg IM | Active comparator | Biological: KIRIM-KONGO-VAX |
| 5 mcg SC | Active comparator | Biological: KIRIM-KONGO-VAX |
| 5 mcg IM control | Placebo comparator | Other: Placebo0.9% NaCl Solution |
| 5 mcg SC control | Placebo comparator | Other: Placebo0.9% NaCl Solution |
| 10 mcg IM | Active comparator | Biological: KIRIM-KONGO-VAX |
| 10 mcg SC | Active comparator | Biological: KIRIM-KONGO-VAX |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KIRIM-KONGO-VAXCrimean-Congo Hemorrhagic Fever Vaccine | Biological | 10 mcg IM, 10 mcg SC, 5 mcg IM, 5 mcg SC |
| Placebo | Other | 5 mcg IM control, 5 mcg SC control |
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.
1 secondary outcome
Immunogenicity
Time frame: One year follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aydın Erenmemisoglu, MD PhD principal investigator
TC Erciyes University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KIRIM-KONGO-VAX in people with Crimean-Congo Hemorrhagic Fever, run by The Scientific and Technological Research Council of Turkey.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2017; AzTrials last refreshed its copy on 29 Oct 2026.