国际著名SCI期刊中国卫生问题研究(七十二)-卫管学术天堂
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选文:西部健康经济与管理研究中心
主审:杨风博士编辑:陆芬
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Immunity duration of a recombinant adenovirus type-5 vector-based Ebola vaccine and a homologous prime-boost immunisation in healthy adults in China:final report of a randomised, double-blind, placebo-controlled吴延睿 , phase 1 trial
Jing-Xin Li; Li-Hua Hou; Fan-Yue Meng; Shi-Po Wu; Yue-Mei Hu; Qi Liang; Kai Chu; Zhe Zhang; Jun-Jie Xu; Rong Tang; Wen-Juan Wang; Pei Liu; Jia-Lei Hu; Li Luo; Rong Jiang; Feng-Cai Zhu; Wei Chen
Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, Jiangsu Province;
Beijing Institute of Biotechnology杨政道 , Fengtai District, Beijing 100039;
Tianjin CanSino Biotechnology Inc, TEDA West District, Tianjin 300457;
and School of Public Health何岩柯 , SoutheastUniversity漆思弓, Nanjing 210009, Jiangsu Province;
Summary
Background: The 2013–15 Ebola virus disease epidemic in west Africa greatly accelerated the development of Ebola vaccine. We aimed to analyse the immune persistence induced by one shot of an adenovirus type-5 vector-based Ebola virus vaccine up to 6 months and the eff ect of boosting with a homologous vector in healthy adults in China.
Methods: In a randomised, double-blind, placebo-controlled, phase 1 clinical trial in one site in Jiangsu Province, China李叶娜 , 120 healthy adults aged 18–60 years received an initial dose of intramuscular adenovirus type-5 Ebola virus vaccine of 4·0 × 101? viral particles, 1·6 × 1011 viral particles梅朵瑞恩 , or placebo, and were followed up to day 168. Participants were subsequently re-recruited to receive a booster dose of the same vaccine or placebo, in the same dose宝日龙梅 , at month 6. Women who were pregnant, breastfeeding, or planned to become pregnant during the next month were excluded. Randomisation was conducted by computer-generated block randomisation. Randomisation data were unmasked for interim analysis of the data obtained between days 0–28 but not disclosed to participants or site staff . Safety and immunogenicity analysis were done on the intention-to-treat population. We aimed to assess the safety profi le of the experimental vaccine and the immunity responses to a single-dose immunisation or a homologous prime-boost regimen. Primary outcomes were Ebola glycoprotein-specifi c ELISA antibody responses 28 days post-boost and the occurrences of adverse reactions post-boost. The original trial and the extended booster study were registered with ClinicalTrials.gov, numbers NCT02326194 and NCT02533791, respectively.
Findings: Between Dec 28, 2014, and Jan 9, 2015, we enrolled 210 volunteers. 90 participants were not randomised due to not meeting inclusion criteria (61), meeting exclusion criteria (4), or withdrawal of consent (25). 120 people were randomly assigned to receive intramuscular Ebola vaccine at 4·0 × 101? viral particles (low dose鹰县事件 , n=40), Ebola vaccine at 1·6 × 1011 viral particles (high dose, n=40), or placebo (n=40, in two groups of 20). After prime vaccination, the geometric mean titer (GMT) of ELISA EC 90 peaked at 682·7 (95% CI 424·3–1098·5) in the low-dose vaccine group and 1305·7 (970·1–1757·2) in the high-dose vaccine group at day 28, and then fell gradually through the next a few months to 575·5 (394·8–838·8) in the high-dose vaccine group and 197·9 (107·9–362·7) in the low-dose vaccine group at day 168. No specific response was recorded in the placebo group with a GMT of 5·0. Of the 120 participants involved in the initial trial, ten participants declined to participate, and 110 were included in the boost immunisation: 38 received the low dose, 35 received the high dose,陈雁升 and 37 received the placebo. At day 28 after boost vaccination, the ELISA EC 90 titres rapidly rose to 6110 (95% CI 4705–7935) in the low-dose group and to 11825 (8904–15705) in the high dose group. 78 of 110 participants reported at least one solicited adverse reaction within the first 7 days after booster administration. Both of the groups who received vaccine showed signifi cantly higher incidence of mild or moderate solicited adverse reactions than did the placebo group.
Interpretation: The adenovirus 5-vectored Ebola vaccine of 1·6 × 1011 viral particles was highly immunogenic and safe. The lower dose of 4·0 × 101? viral particles was also safe, but immunogenicity seemed to be more vulnerable to the pre-existing immunity of adenovirus 5. A homologous priming-boosting regimen with adenovirus type-5 Ebola vaccine at 6 months interval was able to elicit greater antibody responses with longer duration. These results support an immunisation strategy to implement a booster injection for a more durable protection against Ebola virus disease.
Funding: Chinese Ministry of Science and Technology and The National Health and Family Planning Commission, Be ijing Institute of Biotechnology, and Tianjin CanSino Biotechnology.
Origin
Lancet Glob Health 2017;5: e324–34
Lifestyle behaviors and ethnic identity among diverse women at high risk for type 2 diabetes
Susan D. Brown;Samantha F. Ehrlich;Ai Kubo;Ai-Lin Tsai;Monique M. Hedderson面条君 , Charles P. Quesenberry Jr.;Assiamira Ferrara
Division of Research伊川民声网 , Kaiser Permanente Northern California, Oakland兽血沸腾后传 , CA, United States
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Abstract
Background: Diet and physical activity lifestyle behaviors are modifiable risk factors for type 2 diabetes and are shaped by culture, potentially influencing diabetes health disparities.Objectives: We examined whether ethnic identitydthe strength of attachment to one’s ethnic group李嘉一 , and a long-standing focus of psychological researchdcould help account for variations in lifestyle behaviors within a diverse population at high risk for chronic disease.Methods: Using data from the Gestational Diabetes’ Effects on Moms trial, this US-based cross-sectional study included 1463 pregnant women (74% from minority ethnic/racial groups; 46% born outside the US) with gestational diabetes (GDM), a common pregnancy complication conferring high risk for type 2 diabetes after delivery. Mixed linear regression models examined whether ethnic identity is associated with lifestyle behaviors after adjusting for demographic, clinical, and acculturative characteristics (e.g., nativity and length of residence in the US).Results: In the overall sample炒螺明 , a one-unit increase in ethnic identity score was significantly associated with 3% greater fiber intake, 4% greater fruit/vegetable intake, 11% greater total activity龙凌音 , and 11% greater walking (p values < 0.01). Within ethnic/racial groups, a one-unit increase in ethnic identity score was significantly associated with 17% greater fiber intake among Filipina women; 5% lower total caloric intake among non-Hispanic White women; and 40% greater total activity, 35% greater walking, and 8% greatertotal caloric intake among Latina women(p values≤0.03).Conclusion: Results from this large study suggest that ethnic group attachment is associated with some lifestyle behaviors, independent of acculturation indicators, among young women with GDM who are at high risk for type 2 diabetes. Stronger ethnic identity may promote certain choices known to be with reduced risk of type 2 diabetes. Prospective research is needed to clarify the temporal nature of associations between ethnic identity and modifiable diabetes risk factors.
Origin
Social Science & Medicine 160 (2016) 87-93
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