Sağlıklı yetişkinlerde dondurularak kurutulmuş, sıcaklığa dayanıklı deneysel bir tüberküloz (TB) aşısını test eden bir klinik deney, bunun güvenli olduğunu ve hem antikorları hem de bağışıklık sisteminin hücresel kolundan gelen tepkileri uyardığını buldu. Faz 1 denemesi, Ulusal Sağlık Enstitüleri’nin bir parçası olan Ulusal Alerji ve Bulaşıcı Hastalıklar Enstitüsü (NIAID) tarafından desteklenmiştir. Adayın sıcaklığa dayanıklı olmayan bir formu daha önce çeşitli klinik deneylerde test edilmişti. Ancak bu, ısıya dayanıklı (ısıya dayanıklı) bir formda herhangi bir alt ünite TB aşısı adayının ilk klinik denemesiydi. Sonuçlar bugün (6 Mart 2023) dergide yayınlanacak.
The current trial investigated whether administering temperature-stable vaccine containing both ID93 and GLA-SE in a single vial would be as effective at inducing an immune response as a regimen in which non-thermostable ID93 and liquid GLA-SE are held in two vials and combined prior to injection. A single-vial presentation of a thermostable vaccine would have clear advantages in ease of storage, transport and administration, the investigators note.
Daniel F. Hoft, M.D., Ph.D., director of the Saint Louis University Center for Vaccine Development, led the single-site trial at the university’s School of Medicine. Twenty-three participants received the thermostable single-vial regimen, while 22 participants received the two-vial, non-thermostable regimen. Both vaccine presentations were safe and well-tolerated. Recipients of the single-vialled thermostable vaccine had robust T-cell responses and produced higher levels of antibodies in the blood than those receiving the non-thermostable two-vial presentation.
The investigators note some limitations in this small trial. For example, no established correlates of protection define what immune responses are required for vaccine-induced protection from TB disease. Therefore, it is not possible to say whether the enhanced immune responses seen in the thermostable vaccine formulation would translate to improved protective vaccine efficacy. Nevertheless, they conclude, results of this trial demonstrate “a proof-of-concept that adjuvant-containing vaccines can be formulated in a freeze-dried single-vial presentation without detrimentally impacting clinical immunogenicity or safety characteristics.”
Reference: “Safety and immunogenicity of a thermostable formulation of the ID93 + GLA-SE tuberculosis vaccine candidate in healthy adults” by ZK Sagawa et al., 6 March 2023, Nature Communications.