کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
10964642 | 1102722 | 2014 | 5 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Safety and preliminary immunogenicity of Cuban pneumococcal conjugate vaccine candidate in healthy children: A randomized phase I clinical trial
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کلمات کلیدی
موضوعات مرتبط
علوم زیستی و بیوفناوری
ایمنی شناسی و میکروب شناسی
ایمونولوژی
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
A new heptavalent conjugate vaccine (PCV7-TT) is under development in Cuba. PCV7-TT contains 2 μg of serotypes 1, 5, 14, 18C, 19F, 23F and 4 μg of 6B, each one conjugated to tetanus toxoid (TT). This vaccine was designed with the serotypes that cause most invasive pneumococcal diseases (IPD) worldwide. In the present study, we investigated the safety and explored the immunogenicity of PCV7-TT during a controlled, randomized and double blind clinical trial phase I in 4-5-year-old children. PCV7-TT was well tolerated and as safe as Synflorix used as control vaccine. Following a single-dose vaccination, all individual serotypes included in PCV7-TT induced statistically significant increase of IgG GMC and OPA GMT. These are the first clinical results of PCV7-TT in children and they pave the way toward next clinical trials in children and infants. This clinical trial was published in the Cuban Public Register of Clinical Trials with code RPCEC00000173.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Vaccine - Volume 32, Issue 41, 15 September 2014, Pages 5266-5270
Journal: Vaccine - Volume 32, Issue 41, 15 September 2014, Pages 5266-5270
نویسندگان
Carlos P. Dotres, Rinaldo Puga, Yariset Ricardo, Carmen R. Broño, Beatriz Paredes, Vladimir EchemendÃa, Sandra Rosell, Nadezhda González, Dagmar GarcÃa-Rivera, Yury Valdés, Laboratory-Pneumococci Group Laboratory-Pneumococci Group,