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Mao Q.-Y.,Chinese National Institute for the Control of Pharmaceutical and Biological Products | Liao X.-Y.,Chinese National Institute for the Control of Pharmaceutical and Biological Products | Yu X.,Hualan Biological Engineering Inc. | Li N.,Hualan Biological Engineering Inc. | And 7 more authors.
Chinese Medical Journal

Background Enterovirus 71 (EV71) and coxsackievirus A16 (Cox A16) are major causative agents for hand, foot and mouth disease (HFMD). Studies indicate that the frequent HFMD outbreaks result in a few hundreds children's death in China in recent years. The vaccine and other research for HFMD need to be developed urgently. The aims of our study were: to explore dynamic development of mother-source neutralizing antibodies against EV71 and Cox A16 in infants from Jiangsu Province, China, and to provide the fundamental data for further establishing of corresponding immunization course. Methods Peripheral blood samples were collected from 133 of parturient women once immediately before delivery and their infants at two and seven months of age. Method of micro-dose cytopathogenic effect was used to measure neutralizing antibodies against EV71 and Cox A16, respectively. Results Seropositive rates of anti-EV71 and anti-Cox A16 in prenatal women were 79.7% (106/133) and 92.5% (123/133), respectively; geometric mean titers (GMTs) were 29.0 and 61.9; 75.9% (101/133) prenatal women were both positive in anti-EV71 and anti-Cox A16; seropositive rates of anti-EV71 and anti-Cox A16 were 25.6% (34/133) and 38.3% (51/133) in infants at two months of age; GMTs were 12.3 and 18.0, respectively. GMTs of anti-EV71 were significantly higher for infants at seven months (82.6) compared with that at two months (P <0.05), showing infants had inapparently infected by EV71 during two to seven months. Although only one offspring (0.75%) at seven months was found having anti-Cox A16 transfered from maternal, this observation suggested no maternal antibody may remain in infants at seven months. Conclusions The prevalence of EV71 and Cox A16 were relatively high in Jiangsu Province. Bivalent vaccine against both EV71 and Cox A16 should be developed, and the ideal time point for prime immunization for infants is around 2-5 months of age. Source

Wang Z.-Z.,Peking University | Li M.-Q.,U.S. Center for Disease Control and Prevention | Wang P.,U.S. Center for Disease Control and Prevention | Yang Z.-X.,U.S. Center for Disease Control and Prevention | And 6 more authors.

Objectives: To compare immunogenicity of hepatitis B vaccine between the standard 3-dose (20. μg) and 2-dose with higher-dosage (60. μg) regimens in healthy young adults and evaluate the safety profile. Methods: A randomized, parallel-group clinical trial was conducted among healthy young adults aged 18-25 years. Subjects were randomly assigned to three groups. One group was administered hepatitis B vaccine with the standard regimen of 0-1-6 month (20. μg) and other groups were immunized with regimens of 0-1 or 0-2 month (60. μg) respectively. Serum samples were collected at 1 month after a series vaccination and 12 months after the first-dose inoculation for anti-HBs antibody measurement with a Chemiluminescent Microparticle ImmunoAssay (CMIA). Results: The seroprotection rates in 20. μg (0-1-6 month), 60. μg (0-1 month) and 60. μg (0-2 month) groups were 100, 93.64 and 99.19% at month 7/2/3, and 100, 96.04 and 95.90% at month 12, respectively. There were no significant differences among three vaccine groups (p >. 0.05). The geometric mean concentration (GMC) of anti-HBs was significantly higher in 20. μg (0-1-6 month) group than that in 60. μg (0-1 month) group at month 7/2 (1847.99 vs. 839.27. mIU/ml, p = 0.004), but was similar to that in 60. μg (0-2 month) group at month 7/3 (1847.99 vs. 1244.80. mIU/ml, p = 0.138). At month 12, the GMC in 20. μg (0-1-6 month) group was significantly higher than those of other groups (1456.63 vs. 256.30, 235.15. mIU/ml, respectively, p <. 0.001). The total incidence of injection-site or systemic adverse reactions was <3%. Conclusions: A 2-dose with higher-dosage hepatitis B vaccine regimens are comparable to the standard 3-dose regimen in terms of immunogenicity except a relatively rapid decline in GMC levels which are associated with the longevity of protection. All formulations of hepatitis B vaccine were well tolerated. Clinicaltrials.gov identifier: NCT02203357. © 2016 Elsevier Ltd. Source

Chen J.,Peking University | Liang Z.,Chinese National Institute for the Control of Pharmaceutical and Biological Products | Lu F.,Peking University | Fang X.,Chinese National Institute for the Control of Pharmaceutical and Biological Products | And 7 more authors.

It is well documented that 5-10% hepatitis B adult vaccinees are non- and hypo-responders and probably are not adequately protected against hepatitis B virus (HBV) infection. The sequence variations of genes involved in processes such as pathogen recognition, antigen processing and presentation, and differentiation/maturation of lymphocytes may affect the duration and intensity of protective humoral immune response to the hepatitis B vaccine. In this study, frequencies of 53 known SNPs within 21 candidate genes were analyzed among 46 responders and 24 non-responders. Four SNPs (rs2243248, rs1805015, rs1295686 and rs3804100) in IL-4, IL-4RA, IL-13 and TLR2 genes were found significantly associated with the vaccinees' status of serum anti-HBV response triggered by the vaccine (P< 0.05). Two SNPs (rs1295686 and rs1805015) also showed significant association with the vaccine-induced immune response when analyzed together with risk factors such as age and gender, by multivariable logistic regression analysis (P< 0.05). Further, haplotype analysis showed that the AG haplotype defined by SNPs rs1143633 (IL-1B; intron) and rs1143627 (IL-1B; intron) was present more frequently in non-responders than in responders (P=0.035). Thus, specific SNPs in genes of cytokines/cytokine receptors and TLR2 were associated with status of the hepatitis B vaccine-induced protective humoral immune response. © 2010 Elsevier Ltd. Source

Zhu F.-C.,U.S. Center for Disease Control and Prevention | Sun K.-X.,Peking University | Pan H.-X.,U.S. Center for Disease Control and Prevention | Yang Z.-H.,Shenzhen Kangtai Biological Products Co. | And 6 more authors.

Background and Aims: To evaluate immunogenicity and efficacy of a 10 μg recombinant Saccharomyces cerevisiae-derived hepatitis B vaccine (Kangtai Biological Products Co. Ltd, Shenzhen, China) (Hep-KSC) in newborns. Methods: Overall 1197 infants born to mothers negative for HBV markers (NM group) and 534 born to HBsAg-positive mothers (PM Group) were enrolled. Infants in NM group were given 10 μg Hep-KSC, 10 μg Engerix-B or 5 μg Hep-KSC and those in PM group received 10 μg Hep-KSC or 10 μg Engerix-B at 0, 1 and 6 months, with an additional 200 IU HBIG at birth for the latter. Results: For NM Group, 10 μg Hep-KSC paralleled 10 μg Engerix-B but outperformed 5 μg Hep-KSC regarding seroprotective rate (95.06% vs 94.83% vs 89.67%, p = 0.0077) and anti-HBs geometric mean concentration (GMC) (798.87 mIU/ml vs 790.16 mIU/ml vs 242.04 mIU/ml, p < 0.0001) at 7 months. The proportion of infants with anti-HBs greater than 1000 mIU/ml was higher in 10 μg Hep-KSC than 5 μg Hep-KSC group (45.77% vs 11.93%, p < 0.0001) at 7 and 12 months. For PM Group, the HBsAg positivity rate in 10 μg Hep-KSC and 10 μg Engerix-B group was 1.60% and 4.27% at 7 months, respectively. In 10 μg Hep-KSC group, 93.61% and 91.29% achieved seroprotection at 7 and 12 months, respectively, and correspondingly 90.24% and 86.96% in 10 μg Engerix-B group. The anti-HBs GMC was comparable between 10 μg Hep-KSC and 10 μg Engerix-B group at 7 and 12 months (575.31 mIU/ml vs 559.64 mIU/ml; 265.79 mIU/ml vs 264.48 mIU/ml). Conclusions: 10 μg Hep-KSC might be appropriate for neonatal immunization with good immunogenicity and efficacy, especially for infants born to HBsAg-positive mothers. © 2016. Source

Pan H.-X.,U.S. Center for Disease Control and Prevention | Zeng Y.,Shenzhen Kangtai Biological Products Co. | Song X.-F.,Shenzhen Kangtai Biological Products Co. | Zhang Y.-J.,U.S. Center for Disease Control and Prevention | And 3 more authors.

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 60. μg 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 24. h. 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. Clinicaltrials.gov identifier: NCT01203319. © 2014. Source

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