The Phase 19 phase of human trials in the vaccine based on virus-like particles (VLP), developed against Covid-2 and considered one of the most innovative vaccine methods, is starting soon.
The Phase 19 phase of human trials in the vaccine based on virus-like particles (VLP), developed against Covid-2 and considered one of the most innovative vaccine methods, is starting soon. At least 19 volunteers are sought for the new phase of the domestic VLP-based vaccine, which is under the umbrella of the TÜBİTAK COVID-480 Turkey Platform.
Industry and Technology Minister Mustafa Varank, who voluntarily vaccinated in the clinical research Phase 1 study of the VLP vaccine candidate, called for Phase 2. Minister Varank, in his post on his social media account, said, “We successfully completed the Phase 1 phase in our most innovative vaccine candidate. We are looking for volunteers who meet the conditions for the Phase 2 phase of the VLP vaccine, which I volunteer. We want our vaccine to be healing to the world. " used the expressions.
Phase 2 study of the VLP vaccine candidate will be conducted at Kocaeli University and Istanbul Yedikule Chest Diseases Training and Research Hospital under the coordination of Ankara Oncology Training and Research Hospital Clinical Research Center. Applications will be taken from onkoloji.gov.tr and covid19.tubitak.gov.tr.
ITS RELIABILITY PROVEN
Prof. Dr. A new stage was started in the human trials of the domestic VLP vaccine candidate, which was developed as a result of the joint project of Mayda Gürsel and the couple of İhsan Gürsel from Bilkent University. Studies have begun for the Phase 1 phase, which will measure the effectiveness of the VLP vaccine, whose reliability has been proven in Phase 2.
THERE WERE 1 VOLUNTEERS IN PHASE 38
In Phase 1 phase, Industry and Technology Minister Varank, TÜBİTAK President Prof. Dr. At least 38 volunteers will participate in the Phase 2 phase of human trials, where a total of 480 people, together with Hasan Mandal, were vaccinated voluntarily.
OVER 18 YEARS OLD, NO ANTIBODY DEVELOPED IN BODY
Volunteers will be selected from those who are over the age of 18, who do not have any health problems or diseases, and who are in good general health. Volunteers will be asked to not have developed Covid-19 antibodies, and Covid-19 PCR, HIV, Hepatitis B and C tests to be negative.
THERE WILL NOT BE PREGNANT
Pregnant women cannot volunteer. The volunteers will have their complete blood count, liver, kidney function and blood glucose measured. Volunteers will also be asked to sign the informed consent form.
3 DOSE INTERVAL IN 2 WEEKS
480 volunteers who meet all these criteria will be vaccinated by subcutaneous injection method, that is, under the skin, not into the muscle from the arm. Volunteers will be given two doses of vaccine with an interval of 3 weeks.
EFFECTIVE AGAINST THE BRITISH VARIAT
Phase-2 vaccines, which are prepared to be effective against both Wuhan and the British variant, will be administered at Kocaeli University and Istanbul Yedikule Chest Diseases Training and Research Hospital under the coordination of Ankara Oncology Training and Research Hospital Clinical Research Center.
ONE YEAR MONITORING PROCESS
Immunity of the volunteers will be monitored for a year after the vaccinations to be made with an interval of 21 days. Volunteers will be examined at regular intervals during this period.
3 THOUSAND VOLUNTEERS IN PHASE 15
Within 2 days following the completion of Phase 15 vaccination studies in all volunteers, Phase 3, that is, the basic clinical trial phase, which is required for widespread administration, will begin. In Phase 3, vaccines will be administered to more than 40 thousand volunteers in nearly 10 centers to be selected from across Turkey.
IN WHO LIST
World No. TÜBİTAK Covidien-19 Turkey Platform covered by the vaccine candidate developed with a single VLP technology, taking place in the WHO Covidien-30 vaccine candidates list March 19 clinical stage this kind in the world was the 4th vaccine candidate.
FIRST DOSE VACCINE APPLIED ON 17 APRIL
Minister Varank, Mayda and İhsan Gürsel visited Nobel İlaç's Biotechnological Medicine Facility in Gebze TÜBİTAK Marmara Teknokent (MARTEK) in January to see the work of the teachers on site. Varank came to Ankara Oncology Hospital Phase-17 Clinical Research Center on April 1 with TÜBİTAK President Mandal and became the first dose of vaccine. The second dose of vaccine was administered to Varank and Mandal on May 7.
IMMUNE REACTION
In VLP type vaccines, the developed virus-like particles mimic the virus in a way that does not cause infection. While these particles induce an immune response, they do not cause illness.
VACCINE ANTIGEN WITH 4 PROTEINS
Another feature of the vaccine candidate developed by the Gürsel couple is that, unlike other VLP vaccines, 4 structural proteins of the virus are used as vaccine antigens in this platform. In this respect, there is no vaccine candidate entering the clinical phase in the world.
VOLUNTEER AWARENESS
Volunteering is of great importance in Phase 2 and Phase 3 studies of the domestic vaccine. In order to increase the awareness of volunteers, an application page was opened on the website of the TÜBİTAK COVID-19 Turkey Platform and the Ankara Oncology Training and Research Hospital. Those who want to become a volunteer can apply by filling out the "volunteer form" available at onkoloji.gov.tr and covid19.tubitak.gov.tr.
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