Randomized clinical trial of immunogenicity and safety of a recombinant H1N1/2009 pandemic influenza vaccine containing Advax™ polysaccharide adjuvant.
Randomized clinical trial of immunogenicity and safety of a recombinant H1N1/2009 pandemic influenza vaccine containing Advax™ polysaccharide adjuvant.
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DOI：
10.1016/j.vaccine.2012.06.009
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发表时间：
2012-08-03
期刊：
影响因子：
5.5
通讯作者：
Petrovsky N
中科院分区：
文献类型：
--
作者：
Gordon DL;Sajkov D;Woodman RJ;Honda-Okubo Y;Cox MM;Heinzel S;Petrovsky N
在流感大流行期间，及时提供疫苗至关重要。基于重组血凝素（rHA）的疫苗可以克服基于鸡蛋的疫苗的生产障碍，但以前从未在现实生活中的大流行环境中进行过测试。主要目的是确定重组大流行疫苗的功效以及其免疫原性是否可以通过新型多糖佐剂（Advax™）增强。在rHA H1N1/2009疫苗（含或不含佐剂）的随机、受试者和观察者设盲、平行组研究中招募了281名18-70岁的成人。在第0周和第3周用rHA 3、11或45 μ g进行免疫接种。血清学和安全性随访6个月。在基线时，只有9.1%的受试者（95% CI = 6.0 - 13.2）具有血清保护性H1N1/2009滴度。血清转化率因rHA剂量、佐剂存在、受试者年龄和免疫接种次数而异。在接受rHA 45 ug和佐剂的18 - 49奥尔兹中，80%（95% CI = 52 - 96）在第3周时获得血清保护，表示抗体滴度较基线增加11.1倍。与单独的rHA相比，Advax™佐剂在第一次免疫后将血清保护率提高了1.9倍，在第二次免疫后提高了2.5倍。血清保护作用持续到第26周，疫苗耐受性良好，没有安全性问题。该研究证实了在实际流感大流行开始后的短时间内设计、制造和释放重组疫苗的能力。Advax™佐剂显著增强rHA免疫原性。
Timely vaccine supply is critical during influenza pandemics. A recombinant hemagglutinin (rHA)-based vaccine could overcome production hurdles of egg-based vaccines but has never previously been tested in a real-life pandemic setting. The primary aim was to determine the efficacy of a recombinant pandemic vaccine and whether its immunogenicity could be enhanced by a novel polysaccharide adjuvant (Advax™). 281 adults aged 18–70 years were recruited in a randomized, subject and observer blinded, parallel-group study of rHA H1N1/2009 vaccine with or without adjuvant. Immunizations were at 0 and 3 weeks with rHA 3, 11 or 45 ug. Serology and safety was followed for 6 months. At baseline, only 9.1% of subjects (95% CI = 6.0 – 13.2) had seroprotective H1N1/2009 titers. Seroconversion rates varied by rHA dose, presence of adjuvant, subject age and number of immunizations. Eighty percent (95% CI = 52 – 96) of 18 – 49 year olds who received rHA 45ug with adjuvant were seroprotected at week 3, representing a 11.1-fold increase in antibody titers from baseline. Advax™ adjuvant increased seroprotection rates by 1.9 times after the first, and 2.5 times after the second, immunization when compared to rHA alone. Seroprotection was sustained at 26 weeks and the vaccine was well tolerated with no safety issues. The study confirmed the ability to design, manufacture, and release a recombinant vaccine within a short time from the start of an actual influenza pandemic. Advax™ adjuvant significantly enhanced rHA immunogenicity.
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影响因子：
4.4
作者：
Geeraedts F;Bungener L;Pool J;ter Veer W;Wilschut J;Huckriede A
通讯作者：
Huckriede A
DOI：
10.1136/bmj.b3928
发表时间：
2009-10-06
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Garcia-Garcia L;Valdespino-Gómez JL;Lazcano-Ponce E;Jimenez-Corona A;Higuera-Iglesias A;Cruz-Hervert P;Cano-Arellano B;Garcia-Anaya A;Ferreira-Guerrero E;Baez-Saldaña R;Ferreyra-Reyes L;Ponce-de-León-Rosales S;Alpuche-Aranda C;Rodriguez-López MH;Perez-Padilla R;Hernandez-Avila M
通讯作者：
Hernandez-Avila M
影响因子：
6.7
作者：
Geeraedts F;Goutagny N;Hornung V;Severa M;de Haan A;Pool J;Wilschut J;Fitzgerald KA;Huckriede A
通讯作者：
Huckriede A
影响因子：
4.3
作者：
Cooper, Peter D.;Petrovsky, Nikolai
通讯作者：
Petrovsky, Nikolai
影响因子：
3.7
作者：
Nohynek H;Jokinen J;Partinen M;Vaarala O;Kirjavainen T;Sundman J;Himanen SL;Hublin C;Julkunen I;Olsén P;Saarenpää-Heikkilä O;Kilpi T
通讯作者：
Kilpi T