Summary Background Helicobacter pylori is one of the most common gastric pathogens, affecting at least half the world's population, and is strongly associated with gastritis, peptic ulcer, gastric ...adenocarcinoma, and lymphoma. We aimed to assess the efficacy, safety, and immunogenicity of a three-dose oral recombinant H pylori vaccine in children in China. Methods We did this randomised, double-blind, placebo-controlled, phase 3 trial at one centre in Ganyu County, Jiangsu Province, China. Healthy children aged 6–15 years without past or present H pylori infection were randomly assigned (1:1), via computer-generated randomisation codes in blocks of ten, to receive the H pylori vaccine or placebo. Participants, their guardians, and study investigators were masked to treatment allocation. The primary efficacy endpoint was the occurrence of H pylori infection within 1 year after vaccination. We did analysis in the per-protocol population. This trial is registered with ClinicalTrials.gov , number NCT02302170. Findings Between Dec 2, 2004, and March 19, 2005, we randomly assigned 4464 participants to either the vaccine group (n=2232) or the placebo group (n=2232), of whom 4403 (99%) participants completed the three-dose vaccination schedule and were included in the per-protocol efficacy analysis. We extended follow-up to 3 years. We recorded 64 events of H pylori infection within the first year (14 events in 2074·3 person-years at risk in the vaccine group vs 50 events in 2089·6 person-years at risk in the placebo group), resulting in a vaccine efficacy of 71·8% (95% CI 48·2–85·6). 157 (7%) participants in the vaccine group and 161 (7%) participants in the placebo group reported at least one adverse reaction. Serious adverse events were reported in five (<1%) participants in the vaccine group and seven (<1%) participants in the placebo group, but none was considered to be vaccination related. Interpretation The oral recombinant H pylori vaccine was effective, safe, and immunogenic in H pylori -naive children. This vaccine could substantially reduce the incidence of H pylori infection; however, follow up over a longer period is needed to confirm the protection of the vaccine against H pylori -associated diseases. Funding Chongqing Kangwei Biological Technology.
Summary Schistosomiasis remains an important public health issue, with a large number of cases reported across sub-Saharan Africa, and parts of Asia and Latin America. China was once highly endemic, ...but has made substantial progress and is moving towards elimination of schistosomiasis. Meanwhile, despite long-term, repeated, school-based chemotherapy in many African countries, more than 90% of all schistosomiasis cases are concentrated in Africa, and hence, this continent constitutes the key challenge for schistosomiasis control. Opportunities and issues for international collaboration in the fight against schistosomiasis are outlined with a focus on China's experiences, including the role of public health authorities and intersectoral collaboration, use of new and effective snail control approaches and diagnostic tools adapted to the specific stage of control, as well as the strengthening of risk mapping and surveillance-response mechanisms. Training courses targeting African governmental officials and professionals, coupled with field visits of African scientists and control programme managers to China, and vice versa, are considered important for improved schistosomiasis control and elimination. The crucial question remains whether the Chinese experience can be translated and applied in African countries to improve the effectiveness of health interventions and scale-up.
Oxygen reduction reaction (ORR) is Achilles’ heel of zinc‐air battery. The ideal electrocatalyst for ORR should combine both high activity and high stability. In order to achieve this goal, a new N, ...S co‐doped carbon coated Fe3N nanoparticles electrocatalyst with redistributed charge was designed and synthesized. The doping of S elements destroyed the ordered structure of carbon matrix, which cooperated with Fe3N nanoparticles to cause charge redistribution of carbon atoms. Furthermore, the carbon shell protected Fe3N from corrosion during the electrocatalytic process. Fe3N/NSC electrocatalyst showed excellent ORR property with E1/2=0.86 V, and the zinc‐air battery assembled based on it could run stably for more than 650 hours. This work provides a strategy to regulate the redistributed charge of carbon atoms to boost its electrocatalytic activity and stability together.
Carbon shelter: Fe3N@NSC with high activity and excellent stability was synthesized by a facile process. The high activity was obtained due to the co‐doping of N and S into carbon matrix collaboratively with Fe3N that lead to the outflow of electrons from carbon, and the exposure of more positive charges on carbon atoms. Carbon shell protected Fe3N from corrosion during the electrocatalytic process and afforded its excellent stability. Thus, the zinc air battery (ZAB) assembled with Fe3N@NSC as cathode showed great potential for practical applications.
Abstract Background Relapsed or refractory Hodgkin's lymphoma is a challenge for medical oncologists because of poor overall survival. We aimed to assess the feasibility, safety, and efficacy of ...CD30-targeting CAR T cells in patients with progressive relapsed or refractory Hodgkin's lymphoma, in which CD30 expression is mostly positive. Methods This open-label, phase 1 study took place at the Chinese PLA General Hospital. Eligible patients (aged 16–80 years) had relapsed or refractory Hodgkin's lymphoma. All patients received a conditioning chemotherapy regimen at the discretion of physician, followed by the infusion of CD30-directed CAR T cells. Using escalating doses to avoid severe toxicity associated with infusion, patients received a starting dose of 3·2 × 105 CAR T cells per kg and then infused by 5-fold increments continuously for 3–5 days. After the dose-escalation infusion, no patients experienced greater than grade 3 toxicity events. We periodically monitored the expression level of CAR transgenes in peripheral blood and biopsied tumour tissues according to assigned protocol by quantitative PCR. Two-way analysis of variance (ANOVA) was used to determine the significance of the differences between means in all experiments. This trial was approved by the Institutional Review Board at the Chinese PLA General Hospital and is registered with ClinicalTrials.gov , number NCT02259556 . All patients gave written informed consent before enrolment. Findings Between Dec 1, 2014, and Mar 1, 2015, 11 patients were enrolled. All of whom had a heavy pretreatment history (15 previous treatments, range 6–24) or multiple tumour lesions (3·3 lymph node regions involved, range 0-7; involvement of one or more extralymphatic organs), or both. The patients received a mean of 1·5×107 CAR-positive T cell per kg (SD 0·25, range 1·2–2·1) in total during infusion. Nine (82%) patients responded to the treatment: one (9%) patient maintained continuous complete remission, five (46%) patients achieved partial response, and three (27%) patients achieved stable disease. All patients experienced tolerable infusion-related febrile syndrome. One (9%) patient had 5 days of self-limiting arthralgia, myalgia, and dual knee swelling 2 weeks after cell infusion. The copy number of CAR transgene in peripheral blood peaked 3–17 days after infusion, which was accompanied by a two-times higher increase in the number of lymphocytes. Analysis of biopsied tissues revealed a highly efficient trafficking of CAR T cells into the targeted sites. Interpretation CD30-directed CAR T-cell therapy was safe, feasible, and efficient in patients with relapsed or refractory Hodgkin's lymphoma and guaranteed a large-scale patients recruitment. Funding Science and Technology Planning Project of Beijing City (No. Z151100003915076) and National Natural Science Foundation of China (Nos. 31270820, 81230061, 81121004, and 81402566).
Summary Background The combination of stent insertion and single high-dose brachytherapy is a feasible and safe palliative treatment regimen in patients with unresectable oesophageal cancer. We aimed ...to further assess the efficacy of this treatment strategy compared to a conventional covered stent in patients with dysphagia caused by unresectable oesophageal cancer. Methods In this multicentre, single-blind, randomised, phase 3 trial, we enrolled patients with unresectable oesophageal cancer from 16 hospitals in China. We included adult patients (aged ≥20 years) with progressive dysphagia, unresectable tumours due to extensive lesions, metastases, or poor medical condition, and with clear consciousness, cooperation, and an Eastern Cooperative Oncology Group (ECOG) performance status score of 0–3. Eligible patients were randomly assigned (in 1:1 ratio, no stratification) to receive either a stent loaded with125 iodine radioactive seeds (irradiation group) or a conventional oesophageal stent (control group). The primary endpoint was overall survival. Survival analyses were done in a modified intention-to-treat group. This study is registered with ClinicalTrials.gov , number NCT01054274. Findings Between Nov 1, 2009, and Oct 31, 2012, 160 patients were randomly assigned to receive treatment with either an irradiation stent (n=80) or a conventional stent (n=80). During a median follow-up of 138 days (IQR 72–207), 148 stents (73 in the irradiation group and 75 in the control group) were successfully placed into the diseased oesophagus in 148 participants. Median overall survival was 177 days (95% CI 153–201) in the irradiation group versus 147 days (124–170) in the control group (p=0·0046). Major complications and side-effects of the treatment were severe chest pain (17 23% of 73 patients in the irradiation group vs 15 20% of 75 patents in the control group), fistula formation (six 8% vs five 7%), aspiration pneumonia (11 15% vs 14 19%), haemorrhage (five 7% vs five 7%), and recurrent dysphagia (21 28% vs 20 27%). Interpretation In patients with unresectable oesophageal cancer, the insertion of an oesophageal stent loaded with125 iodine seeds prolonged survival when compared with the insertion of a conventional covered self-expandable metallic stent. Funding National High-tech Research Foundation of China, National Basic Research Program of China, Jiangsu Provincial Special Program of Medical Science, National Scientific and Technical Achievement Translation Foundation, and National Natural Science Foundation of China.
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