Advax™，基于Delta菊糖，当与乙肝表面抗原，制定了新的多糖

StephenW

Source: Vaccine  |  Posted 3 days ago
Immunogenicity and safety of Advax™, a novel polysaccharide adjuvant based on delta inulin, when formulated with hepatitis B surface antigen: A randomized controlled Phase 1 study; Gordon D, Kelley P, Heinzel S, Cooper P, Petrovsky N; Vaccine (Sep 2014)

   

There is a need for additional safe and effective human vaccine adjuvants. Advax™ is a novel adjuvant produced from semi-crystalline particles of delta inulin. In animal studies Advax enhanced humoral and cellular immunity to hepatitis B surface antigen (HBsAg) without inducing local or systemic reactogenicity. This first-in-man Phase 1 clinical trial tested the safety and tolerability of three intramuscular doses of HBsAg formulated with Advax in a group of healthy adult subjects. Advax was well tolerated with injection site pain scores not significantly different to subjects receiving HBsAg alone and no adverse events were reported in subjects that received Advax. Seroprotection and HBsAb geometric mean titers (GMT) after three immunizations were higher in the Advax 5mg (seroprotection 5/6, 83.3%, GMT 40.7, 95% CI 11.9-139.1) and 10mg (seroprotection 4/5, 80%, GMT 51.6, 95% CI 10.0-266.2) groups versus HBsAg alone (seroprotection 1/5, 20%, GMT 4.1, 95% CI 1.3-12.8). Similarly the proportion of subjects with positive CD4 T-cell responses to HBsAg was higher in the Advax 5mg (4/6, 67%) and Advax 10mg (4/5, 80%) groups versus HBsAg alone (1/5, 20%). These results confirm the safety, tolerability and immunogenicity of Advax adjuvant observed in preclinical studies. Advax may represent a suitable replacement for alum adjuvants in prophylactic human vaccines subject to confirmation of current results in larger studies. Australia and New Zealand Clinical Trial Registry: ACTRN12607000598482.

StephenW

资料来源：疫苗|发表于3天前
免疫原性和Advax™，基于Delta菊糖，当与乙肝表面抗原，制定了新的多糖佐剂的安全性的随机对照第一阶段的研究;戈登D，凯利磷，Heinzel S，库珀磷，彼得罗夫斯基N;疫苗（2014年9月）

   

有需要额外的安全有效的人用疫苗佐剂。 Advax™是从三角形菊糖的半结晶颗粒产生了一种新的佐剂。在动物研究中Advax增强体液和细胞免疫对乙肝表面抗原（HBsAg）而不会引起局部或全身反应原性。这种先入人第1阶段临床试验测试了三个肌内剂量的HBsAg中的一组健康成年受试者的配制Advax的安全性和耐受性。 Advax耐受性良好，注射部位疼痛评分没有显著不同仅获得HBsAg的科目，也没有不良反应报告在接受Advax科目。血清保护和乙肝表面抗体几何平均滴度（GMT）经过三次免疫接种是在Advax5毫克（血清保护5/6，83.3％，40.7 GMT，95％CI为11.9-139.1）和10毫克（血清保护五分之四，80％，51.6北京时间高，95％CI为10.0-266.2）组与单纯乙肝表面抗原（血清保护五分之一，20％，格林尼治标准时间4.1，95％CI为1.3-12.8）。同样的受试者阳性的CD4 T细胞应答对HBsAg的比例是在Advax5毫克（4/6，67％）和Advax10毫克（五分之四，80％）组与HBsAg的单独（五分之一，20％高）。这些结果证实Advax佐剂在临床前研究中观察到的安全性，耐受性和免疫原性。 Advax可能是一个合适的替代品用于预防人类疫苗受到更多的研究确认了目前的结果明矾佐剂。澳大利亚和新西兰临床试验注册地：ACTRN12607000598482。

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新的疫苗？

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疫苗佐剂.