The Erciyes University Vaccine Research and Development Application and Research Center (ERAGEM) was established using the internal resources of Erciyes University and is accredited to meet World Health Organization (WHO) standards. It houses Biosafety Level 2 (BSL-2), Biosafety Level 3 (BSL-3), and Animal Biosafety Level 3 (ABSL-3) laboratories. ERAGEM commenced its vaccine development efforts in 2013 and was officially founded on May 3, 2015, following the publication of the regulation in the Official Gazette numbered 29344 (http://www.resmigazete.gov.tr/eskiler/2015/05/20150503-13.htm). As a center equipped with BSL-3 laboratories that ensure high biosafety standards in Turkey, it specializes in conducting research and development activities related to vaccines, particularly against viral diseases.
The infrastructure project for establishing the pilot facility required for the production of vaccine doses to be used in Phase 1, Phase 2, and Phase 3 clinical trials was approved by the Presidency of Strategy and Budget under the Infrastructure Support Program in October 2018. The tender for the project titled “Establishment of a GMP Laboratory for Crimean-Congo Hemorrhagic Fever (CCHF) Vaccine Phase Studies” was conducted in March 2020, and the contract was signed in April 2020, marking the beginning of the construction phase.
ERAGEM has achieved significant milestones in the development of vaccines against critical viral diseases. The inactivated whole-virus vaccine (KKA-Vax) developed for Crimean-Congo Hemorrhagic Fever (CCHF) underwent Phase 1 trials in April 2017, successfully tested on 52 volunteers at the Erciyes University Good Clinical Practices Center (İKUM). Furthermore, a CCHF vaccine development project supported by TÜBİTAK (1003 - Priority Areas R&D Projects Support Program) was completed in 2019. The adenovirus vector-based vaccine developed in this project demonstrated 100% protection in animal models.
As of 2020, following the global emergence of COVID-19, which was declared a pandemic by the World Health Organization (WHO), ERAGEM quickly initiated vaccine development efforts shortly after the virus was detected in Turkey. Utilizing the Biosafety Level 3 (BSL-3) and Animal Biosafety Level 3 (ABSL-3) laboratories at the center, the virus was first isolated as part of a project in collaboration with the Turkish Ministry of Health, the Turkey Health Institutes Association (TÜSEB), and Erciyes University. Subsequently, the preclinical studies of the inactivated whole-virus vaccine were completed. During this process, Phase 1 and Phase 2 clinical trials were conducted in collaboration with the Erciyes University Good Clinical Practices Center (İKUM). The Phase 3 trials, coordinated by the Turkish Ministry of Health and conducted nationwide, led to the emergency use authorization of the TURKOVAC vaccine in December 2021.
During the development of the TURKOVAC vaccine, ERAGEM successfully isolated the wild-type Wuhan strain of SARS-CoV-2 (SARS-CoV-2/human/TUR/ERAGEM-001/2020) and mapped its full genome. Emerging variants of concern during the pandemic, such as Alpha, Delta, Omicron, BA.5, and XBB, were also rapidly isolated, and their genome sequences were completed. The effectiveness of the TURKOVAC vaccine against these variants was investigated through experiments on transgenic mice and by analyzing the sera of volunteers participating in the Phase trials.
In 2022, research on the adenovirus vector-based vaccine developed against Crimean-Congo Hemorrhagic Fever (CCHF) resumed. As part of a project supported by TÜSEB in 2023, the goal is to complete the preclinical phase by 2025 and fulfill the necessary conditions for transitioning to the clinical phase.
