Efficacy, safety, and immunogenicity of an enterovirus 71 vaccine in China.

BACKGROUND: Enterovirus 71 (EV71) is one of the major causative agents of outbreaks of hand, foot, and mouth disease or herpangina worldwide. This phase 3 trial was designed to evaluate the efficacy, safety, and immunogenicity of an EV71 vaccine. METHODS: We conducted a randomized, double-blind, placebo-controlled, multicenter trial in which 10,007 healthy infants and young children (6 to 35 months of age) were randomly assigned in a 1:1 ratio to receive two intramuscular doses of either EV71 vaccine or placebo, 28 days apart. The surveillance period was 12 months. The primary end point was the occurrence of EV71-associated hand, foot, and mouth disease or herpangina. RESULTS: During the 12-month surveillance period, EV71-associated disease was identified in 0.3% of vaccine recipients (13 of 5041 children) and 2.1% of placebo recipients (106 of 5028 children) in the intention-to-treat cohort. The vaccine efficacy against EV71-associated hand, foot, and mouth disease or herpangina was 94.8% (95% confidence interval [CI], 87.2 to 97.9; P<0.001) in this cohort. Vaccine efficacies against EV71-associated hospitalization (0 cases vs. 24 cases) and hand, foot, and mouth disease with neurologic complications (0 cases vs. 8 cases) were both 100% (95% CI, 83.7 to 100 and 42.6 to 100, respectively). Serious adverse events occurred in 111 of 5044 children in the vaccine group (2.2%) and 131 of 5033 children in the placebo group (2.6%). In the immunogenicity subgroup (1291 children), an anti-EV71 immune response was elicited by the two-dose vaccine series in 98.8% of participants at day 56. An anti-EV71 neutralizing antibody titer of 1:16 was associated with protection against EV71-associated hand, foot, and mouth disease or herpangina. CONCLUSIONS: The EV71 vaccine provided protection against EV71-associated hand, foot, and mouth disease or herpangina in infants and young children. (Funded by Sinovac Biotech; ClinicalTrials.gov number, NCT01507857.).

[Rate of infection and related risk factors on hepatitis C virus in three counties of Jiangsu province].

OBJECTIVE: To investigate the hepatitis C virus (HCV) infection rate among general population in Jiangsu province and to analyze the main risk factors for HCV infection. METHODS: Subjects in 3 counties were surveyed by stratified cluster random sampling in the National Major Science and Technology Projects demonstration area in Jiangsu province. Interview was carried out with uniformly- designed questionnaires. Blood samples were collected and anti-HCV tested. Data were analysed under SPSS 13.0. Case-control study was conducted on two groups with subjects under 1:4 matching by sex, age, village of residence and status of HCV infection. Cox's proportional hazards regression analysis was then performed to analyze the risk factors for HCV infection. RESULTS: The positive rate of anti-HCV was higher in females (0.965%, 95%CI:0.899%-1.035%) than in males (0.572%, 95%CI:0.517%-0.632%). Significant differences were noticed among the positive rates of anti-HCV in the three counties (0.131%, 95%CI:0.103%-0.164%;0.316%, 95%CI: 0.268%-0.370%; 2.173% , 95% CI:2.039%-2.315% , respectively). Peak prevalence of anti-HCV (1.577%, 95%CI:1.425%-1.740%) was observed among persons at 50-59 years of age. Bottom rate (0.161%, 95%CI:0.125%-0.204%) was observed below 30 years of age. High anti-HCV positive rate was detected in people with lower education background or belonged to 'floating population'. Factors as having histories of hospitalization (OR = 3.049, 95% CI:1.322-7.036), blood transfusion (OR = 14.319, 95%CI:2.318-88.459) or sharing razor (OR = 3.604, 95%CI:1.096-11.851) were risk factors of HCV infection in the area with the lowest anti-HCV positive rate. In another county, factor as having histories of 'blood products transfusion' (OR = 7.202, 95% CI:1.170-44.310) appeared important while in the third county, having history of 'blood donation' (OR = 7.496, 95%CI:6.121- 9.180); 'blood transfusion' (OR = 2.305, 95%CI:1.578-3.369) and 'invasive physical examination' (OR = 1.258, 95% CI:1.021-1.549) appeared to be important. Age seemed a risk factor for HCV infection. "Sharing razor" was a specifically important risk factor among the 30- year-olds. "Having received acupuncture" was noticed a risk factor only among people at 50-59 years of age while "Having received invasive physical examination" was important in the 50-59 and 60-69 year-olds. CONCLUSION: High anti-HCV positive rate was observed in people at middle of aged population, as well as in those with poor education or under 'floating'. Unsafe blood donation or having received blood-product transfusion might be the risk factors in the last decades. Factors as sharing razor, having received acupuncture or invasive examination might be specifically risky in different populations.

New loci associated with chronic hepatitis B virus infection in Han Chinese.

Chronic hepatitis B virus (HBV) infection is a challenging global health problem. To identify genetic loci involved in chronic HBV infection, we designed a three-phase genome-wide association study in Han Chinese populations. The discovery phase included 951 HBV carriers (cases) and 937 individuals who had naturally cleared HBV infection (controls) and was followed by independent replications with a total of 2,248 cases and 3,051 controls and additional replications with 1,982 HBV carriers and 2,622 controls from the general population. We identified two new loci associated with chronic HBV infection: rs3130542 at 6p21.33 (near HLA-C, odds ratio (OR) = 1.33, P = 9.49 × 10(-14)) and rs4821116 at 22q11.21 (in UBE2L3, OR = 0.82, P = 1.71 × 10(-12)). Additionally, we replicated the previously identified associations of HLA-DP and HLA-DQ variants at 6p21.32 with chronic HBV infection. These findings highlight the importance of HLA-C and UBE2L3 in the clearance of HBV infection in addition to HLA-DP and HLA-DQ.