NCT03020771

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

Completed Phase 1 Last updated 16 October 2017

What this trial tests

Phase 1 trial testing KIRIM-KONGO-VAX in Crimean-Congo Hemorrhagic Fever in 60 participants. Completed in 1 June 2017.

Timeline

1 December 2014

Primary endpoint
1 June 2017

1 June 2017

Quick facts

Lead sponsor	The Scientific and Technological Research Council of Turkey
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	60
Start date	1 December 2014
Primary completion	1 June 2017
Estimated completion	1 June 2017

Drugs / interventions tested

• KIRIM-KONGO-VAX — full drug profile →
• Placebo

Conditions studied

• Crimean-Congo Hemorrhagic Fever — all drugs for Crimean-Congo Hemorrhagic Fever →

Sponsor

The Scientific and Technological Research Council of Turkey

Who can join

Adults 18 to 55, any sex, with Crimean-Congo Hemorrhagic Fever. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. COVID-19 vaccines: breaking record times to first-in-human trials.
   Kim YC, Dema B, Reyes-Sandoval A. · · 2020 · cited 77× · PMID 32377399 · DOI 10.1038/s41541-020-0188-3
2. UK vaccines network: Mapping priority pathogens of epidemic potential and vaccine pipeline developments.
   Noad RJ, Simpson K, Fooks AR, Hewson R, et al · · 2019 · cited 23× · PMID 31522809 · DOI 10.1016/j.vaccine.2019.09.009
3. Crimean-Congo Hemorrhagic Fever Virus for Clinicians-Diagnosis, Clinical Management, and Therapeutics.
   Frank MG, Weaver G, Raabe V, State of the Clinical Science Working Group of the National Emerging Pathogens Training, et al · · 2024 · cited 18× · PMID 38666553 · DOI 10.3201/eid3005.231648
4. Development of a protective inactivated vaccine against Crimean-Congo hemorrhagic fever infection.
   Berber E, Çanakoğlu N, Tonbak Ş, Ozdarendeli A. · · 2021 · cited 14× · PMID 34703927 · DOI 10.1016/j.heliyon.2021.e08161
5. Therapeutic management of Crimean-Congo haemorrhagic fever.
   de la Calle-Prieto F, Martín-Quirós A, Trigo E, Mora-Rillo M, et al · · 2018 · cited 10× · PMID 28669587 · DOI 10.1016/j.eimc.2017.04.007
6. Crimean-Congo haemorrhagic fever (CCHF): present and future therapeutic armamentarium.
   Di Bella S, Babich S, Luzzati R, Cavasio RA, et al · · 2024 · cited 2× · PMID 39660152 · DOI 10.53854/liim-3204-2
7. Manejo terapéutico de la fiebre hemorrágica de Crimea-Congo Therapeutic management of Crimean-Congo haemorrhagic fever
   · 2017