Yerli aşı TURKOVAC'ta yeni gelişme
Ankara Şehir Hastanesi Genel Hastane Başhekimi Doç. Dr. İhsan Ateş, yerli covid-19 aşısı Turkovac’da kaydedilen önemli aşamaya ilişkin açıklamalarda bulundu.
Turkovac Faz-3 A rapel doz çalışmasına ilişkin açıklamalarda bulunan Ankara Şehir Hastanesi Genel Hastane Başhekimi Doç. Dr. İhsan Ateş, “Daha önce Covid-19 enfeksiyonu geçirmemiş gönüllülere yapılacak bir rapel doz çalışmasıdır. Çalışmanın özelliği ise Faz-3 A dediğimiz açık etiketli bir çalışma. Yani gönüllümüz, gönüllülük kriterlerini taşıdığı takdirde bu aşıyı kendi seçiyor. İsteyen gönüllümüze Coronavac, isteyen gönüllümüze de Turkovac yapıyoruz. Çalışma yaklaşık 7 bin 400 kişilik bir çalışma.
İki kollu, 3 bin 700 Turkovac 3 bin 700 Coronavac gönüllüsü dahil edeceğiz. Dün itibariyle gönüllülerimizi almaya başladık. Çok fazla gönüllü başvurusu var. Şu anda gönüllüleri kriterlere göre seçmeye başladık. An itibariyle 100'ün üzerinde gönüllünün kriterlere uygun olduğunu saptadık ve şu anda aşılamaya başlamış bulunmaktayız. Faz-3 A çalışmamıza 41 merkezde başladık. Büyükşehirlerimiz Ankara, İstanbul, Adana, Gaziantep, Bursa dahil olmak üzere 41 merkezde Faz-3 A çalışmalarımızı yürüteceğiz” diye konuştu.
"111 Turkovac, 111 Coronavac gönüllüsü üzerinde çift kör randomize bir çalışma tamamladık"
Faz-3 A çalışması öncesinde tamamlanan Faz-2 B çalışması hakkında önemli bilgiler aktaran Başhekim Doç. Dr. Ateş, “Bu çalışmadan önce Faz-2 B Rapel doz çalışmasını yaptık. Daha önce de belirttiğimiz gibi 111 Turkovac, 111 Coronavac gönüllüsü üzerinde çift kör randomize bir çalışma tamamladık. Dün itibariyle birinci aydaki etkinlik verilerimizi son gönüllümüzün de antikor düzeylerine bakara etkinlik verilerimize ulaştık. Tabi ki bu Faz-2 B çalışmamızın hem etkinlik hem de güvenlik verilerinin olumlu olması üzerine Faz-3 A çalışmamıza başladık. Buradan şöyle bir müjde verebiliriz; Turkovac aşımız Coronavac ile yaptığımız Faz-2 B çift kör randomize çalışmada hem güvenli olduğu saptandı hem de etkinlik noktasında olumlu verilerimiz var” açıklamasında bulundu.
"Bazı parametrelerde çok daha iyi sonuçlar elde ettik, bazı parametrelerde de benzer yanıtlar elde ettik"
Faz-2 B çalışması kapsamında Coronavac ile karşılaştırmalı olarak incelendiğinin ve bu sonuçların nasıl olduğu sorusunu yanıtlayan Başhekim Doç. Dr. Ateş, “Burada karşılaştırma aşısı olduğu için Delta'ya Alfa'ya ve orijinal Wuhan virüsüne karşı antikor titrelerini inceledik. Bazı parametrelerde çok daha iyi sonuçlar elde ettik, bazı parametrelerde de benzer yanıtlar elde ettik. Bir aşının Acil Kullanım Onayı (AKO) alabilmesi için Dünya Sağlık Örgütü (DSÖ) tarafından belirlenen bazı kriterler var. Bu kriterlere uyum sağlandığı takdirde gerekli komisyonlar bir araya gelip etkinlik verilerini inceleyerek Acil Kullanım Onayı vereceklerdir” ifadelerini kullandı.
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