Immune response to hepatitis B vaccine with high antigen content in non-responders after standard primary vaccination in Chinese adults.

CONTEXT: Alternative schedules are needed to provide greater immunogenicity in adults who fail to respond to the standard hepatitis B (HB) vaccine regimen. OBJECTIVE: To evaluate the immunogenicity and safety of high antigen content HB vaccine formulations administered to non-responders after routine primary vaccination. DESIGN SETTING, AND PARTICIPANTS: This was a phase III, double-blind, controlled clinical trial in China. We enrolled healthy participants (16-60 years old) seronegative for HB surface (HBs) antigen after primary vaccination, who had HBs antibody (anti-HBs) titres <10 mIU/ml at 28 days following routine vaccination with licensed HB vaccine containing 10 µg of antigen. Participants were randomised (2:2:1) to receive three booster doses of HB vaccine formulations containing 60 µg, 30 µg or 10 µg of antigen per dose 28 days apart. Blood samples were obtained pre-vaccination and 28 days after each dose to assess immunogenicity. Reactogenicity and safety were evaluated up to 28 days after each vaccine dose. RESULTS: Seroconversion rates were ≥ 92.1% and ≥ 87.1% as from the second dose of the 60 µg and 30 µg HB vaccine formulations, respectively, with geometric mean concentrations (GMCs) of ≥ 286.0 mIU/ml and ≥ 164.0 mIU/ml. In the 10 µg HB vaccine group the seroconversion rates were ≥ 83.0% and the GMCs ≥ 110.1 mIU/ml as from the second vaccine dose. All HB vaccine formulations were well tolerated: 352/1091 (32.3%) participants reported at least one injection-site or systemic adverse reaction (145/434 [33.4%] from the 60µg group; 138/435 [31.7%] from the 30 µg group and 69/222 [31.1%] from the 10 µg group). Most reactions were mild or moderate and resolved within 24h. No serious adverse events were reported. CONCLUSION: Booster vaccination with a three-dose schedule of a high antigen content HB vaccine formulation was immunogenic and well tolerated in healthy adults. Clinicaltrialsgov Identifier: NCT01203319.

Retrospective study of the incidence of HFMD and seroepidemiology of antibodies against EV71 and CoxA16 in prenatal women and their infants.

BACKGROUND: Hand, foot, and mouth disease (HFMD) has been emerging as an important public problem over the past few decades, especially in Asian and Pacific regions. A national program on EV71 vaccine development against HFMD was initiated in China, in 2008, which called for a need for seroepidemiological study for the target population. METHODOLOGY/PRINCIPAL FINDINGS: This was a retrospective study conducted in Jiangsu Province, in October, 2010. We measured the neutralizing antibodies against EV71 and CoxA16 in a cohort of infants aged of 2, 7, 12, and 27-38 months and their mothers just before delivery. Series sera samples from 975 infants and 555 mothers were collected and analyzed. Questionnaires on the history of HFMD were completed in the survey. A total of 143 HFMD cases were collected, but only 11.2% were reported to the National Infectious Disease Information Management System. The level of maternal antibody titers decreased dramatically during the first 7 month and remained at a relatively low level thereafter. But it increased significantly from month 12 to months 27-38. The accumulate incidence density of HFMD demonstrated a significant increase after 14 months of age, resulting in a accumulate incidence density of 50.8/1000 person-years in survey period. Seropositivity of EV71 antibody in infants at the age of 2 months seems to demonstrate a protective effect against HFMD. CONCLUSIONS AND SIGNIFICANCE: High seropositive rate of EV71 and CoxA16 antibody was found in prenatal women in mainland China, and there is a need to enhance the HFMD case management and the current surveillance system. We suggest that infants aged between 6 to 14 months should have the first priority to receive EV71 vaccine.

[Influence of hydrogen sulfide on important organs in rats with severe burn].

OBJECTIVE: To investigate the changes in hydrogen sulfide (H2S) and cystathionine gamma-lyase (CSE) in rats with severe burn, and to analyze the effects on important organs. METHODS: One hundred and four healthy male SD rats were divided into normal control group (NC, n = 8), burn group (B, n = 48), and H2S intervention group (HI, n = 48) according to the random number table. SD rats in HI group were intraperitoneally injected with NaHS (56 micromol/kg) once a day for 5 days. Then rats in HI and B groups were subjected to 30% TBSA full-thickness burn. Blood sample as well as heart, liver, lung, kidney, and stomach tissue samples were harvested from rats in B group at post burn hour (PBH) 2, 6, 12, 24, 48, and 96 respectively for determination of serum content of H2S and CSE activity. Serum content of alanine transaminase (ALT), aspartate aminotransferase (AST), MB isoenzyme of creatine kinase (CK-MB), urea nitrogen (BUN), and creatinine (Cr) in HI and B groups were examined at each time point. Samples were harvested from above organs in each group for histomorphological observation. Above-mentioned indexes were also determined in NC group as control. Data were processed with SNK- q test, t test, correlation analysis (between serum content of H2S and CSE activities, biochemical indexes). RESULTS: Serum content of H2S and CSE activities of above organs (except for lung tissue at PBH 48, 96) in B group within PBH 96 were lower than those in NC group, reaching minimum values at PBH 6 or 12. Compared with those in NC group, serum contents of all biochemical indexes in B group were obviously increased within PBH 48, in which serum contents of BUN [(32.5 +/- 9.8) mmol/L] and Cr [(65 +/- 9) micromol/L] reached peak at PBH 6, and serum contents of ALT [(423 +/- 59) U/L], AST [(993 +/- 60) U/L], and CK-MB [(49 261 +/- 6637) U/L] peaked at PBH 12. Serum contents of all biochemical indexes in HI group at each time point were significantly decreased as compared with those in B group, but the same change tendencies were showed in both groups. Histomorphological observation showed that all the organs were severely injured in B group at PBH 24, whereas those in HI group were markedly ameliorated. Serum content of H2S in B group was respectively correlated with CSE activities of all organs (with r value from 0.639 to 0.894, P values all below 0.005) and serum contents of biochemical indexes (with r value from 0.301 to 0.585, P values all below 0.001). CONCLUSIONS: H2S/CSE system may take part in pathophysiological process in rats with severe burn. Exogenous H2S replacement therapy can protect important organs of rats with severe burn.