کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
10962785 | 1102652 | 2016 | 7 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Adenovirus type 35-vectored tuberculosis vaccine has an acceptable safety and tolerability profile in healthy, BCG-vaccinated, QuantiFERON®-TB Gold (+) Kenyan adults without evidence of tuberculosis
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کلمات کلیدی
Viral particleURIPTTBCGCPKALTMTBPPDBacillus Calmette-Guérin - Bacillus Calmette-GuerinAdenovirus - آدنوویروسAlanine aminotransferase - آلانین آمینوترانسفرازSafety - ایمنیTuberculosis - بیماری سلPartial thromboplastin time - زمان ترومبوپلاستین جزئی استprothrombin time - زمان پروترومبینadverse event - عارضه جانبی یا عوارض جانبیMycobacterium tuberculosis - مایکوباکتریوم توبرکلوزیسpurified protein derivative - مشتق شده پروتئین خالصImmunity - مصونیتVaccine - واکسنCreatine phosphokinase - کراتین فسفوکیناز
موضوعات مرتبط
علوم زیستی و بیوفناوری
ایمنی شناسی و میکروب شناسی
ایمونولوژی
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چکیده انگلیسی
In a Phase 1 trial, we evaluated the safety of AERAS-402, an adenovirus 35-vectored TB vaccine candidate expressing 3 Mycobacterium tuberculosis (Mtb) immunodominant antigens, in subjects with and without latent Mtb infection. HIV-negative, BCG-vaccinated Kenyan adults without evidence of tuberculosis, 10 QuantiFERON®-TB Gold In-Tube test (QFT-G)(â) and 10 QFT-G(+), were randomized 4:1 to receive AERAS-402 or placebo as two doses, on Days 0 and 56, with follow up to Day 182. There were no deaths, serious adverse events or withdrawals. For 1 AERAS-402 QFT-G(â) and 1 AERAS-402 QFT-G(+) subject, there were 3 self-limiting severe AEs of injection site pain: 1 after the first vaccination and 1 after each vaccination, respectively. Two additional severe AEs considered vaccine-related were reported after the first vaccination in AERAS-402 QFT-G(+) subjects: elevated blood creatine phosphokinase and neutropenia, the latter slowly improving but remaining abnormal until study end. AERAS-402 was not detected in urine or throat cultures for any subject. In intracellular cytokine staining studies, curtailed by technical issues, we saw modest CD4+ and CD8+ T cell responses to Mtb Ag85A/b peptide pools among both QFT-G(â) and (+) subjects, with trends in the CD4+ T cells suggestive of boosting after the second vaccine dose, slightly more so in QFT-G(+) subjects. CD4+ and CD8+ responses to Mtb antigen TB10.4 were minimal. Increases in Adenovirus 35 neutralizing antibodies from screening to end of study, seen in 50% of AERAS-402 recipients, were mostly minimal. This small study confirms acceptable safety and tolerability profiles for AERAS-402, in line with other Phase 1 studies of AERAS-402, now to include QFT-G(+) subjects.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Vaccine - Volume 34, Issue 21, 5 May 2016, Pages 2430-2436
Journal: Vaccine - Volume 34, Issue 21, 5 May 2016, Pages 2430-2436
نویسندگان
Douglas S. Walsh, Victorine Owira, Mark Polhemus, Lucas Otieno, Ben Andagalu, Bernhards Ogutu, John Waitumbi, Anthony Hawkridge, Barbara Shepherd, Maria Grazia Pau, Jerald Sadoff, Macaya Douoguih, J. Bruce McClain,