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To prospectively evaluate the efficacy of vaccine alone compared with vaccine plus HBIG for preventing HBV transmission in neonates of HBsAg (+)/HBeAg (−) mothers.Combined immunization is currently recommended for neonates of HBsAg (+) mothers in China. As a result, a randomized design is infeasible due to ethical reasons. In practice, Guangxi Zhuang Autonomous Region and Jiangsu Province implement...
The capsid (Cap) protein, an important immunoprotective protein of porcine circovirus type 2 (PCV2), was expressed on the cell surface of the Gram-positive food-grade bacterium, Lactococcus lactis. Cap protein was fused to the peptidoglycan binding domain (known as the protein anchor domain, PA) of the lactococcal AcmA cell-wall hydrolase. The Cap protein fusion was non-covalently rebound to the surface...
The fungus of Ganoderma is a basidiomycete that possesses a variety of pharmacological effects and has been used in traditional Asian medicine for centuries. Ganoderma formosanum is a native Ganoderma species isolated in Taiwan, and we have previously demonstrated that PS-F2, a polysaccharide fraction purified from the submerged culture broth of G. formosanum, exhibits immunostimulatory properties...
Studies regarding the clinical benefits of influenza vaccination in diabetic patients are limited. This study evaluated if the elderly diabetic patients who have had influenza vaccination would have benefits such as reduced medical care and mortality.We used the universal insurance claims data from 2001 to 2009 in Taiwan to identify annual elderly patients with diabetes cohorts with (N=4454) and without...
Oral delivery with virus-like particles (VLPs) is advantageous because of the inherited entry pathway from their parental viral capsids, which enables VLP to withstand the harsh and enzymatic environment associated with human digestive tract. However, the repeat use of this system is challenged by the self-immunity. In order to overcome this problem, we engineered the recombinant capsid protein of...
The high maternal HBV DNA level is the most important factor contributing to HBV perinatal transmission. This study is to explore whether HBsAg can be used as a surrogate marker of serum HBV DNA for HBsAg-positive pregnant women.A total of 975 HBsAg-positive pregnant women and their infants were enrolled in this study. All infants received three doses of a yeast-derived recombinant Hepatitis B vaccine...
There is an urgent need for a novel vaccine that is effective against human Enterovirus 71 (EV71) outbreaks. A double-blind, randomized controlled study was to evaluate the safety and immunogenicity of a human EV71 vaccine in healthy adults, children and infants. The vaccine dosages were 200U and 400U for children and adults, and 100U, 200U and 400U for infants. Subjects were randomized to receive...
This study assessed the antibody persistence, and the immunogenicity and safety of a booster dose of a DTaP–IPV//PRP∼T (Pentaxim ® , Sanofi Pasteur's AcXim family) combined vaccine and of standalone vaccines one year after primary vaccination in the People's Republic of China. Participants (N=719) previously primed with DTaP–IPV//PRP∼T at 2, 3, 4months (Group A, N=255), 3, 4, 5months (Group...
The aim was to demonstrate the immunogenicity and safety of a DTaP-IPV//PRP-T combined vaccine (Pentaxim ® ) compared to individual vaccines in infants in the People's Republic of China. Infants (N=792) were randomly assigned to receive DTaP-IPV//PRP-T at 2, 3 and 4 months of age (Group A) or 3, 4 and 5 months of age (Group B), or DTaP (Wuhan Institute of Biological Products), PRP-T (Act-Hib...
G22, an anti-idiotype single chain antibody screened from human nasopharyngeal carcinoma phage anti-idiotype antibody library, has been already identified by He et al.G22 DNA vaccine was produced by cloning G22 gene and inserting the cloned gene into pcDNA3.1. To investigate the immunogenicity of pcDNA3.1-G22, C57BL/6 mice were immunized with the vaccine, pcDNA3.1 and PBS individually and the antibody...
The candidate recombinant hepatitis E vaccine, HEV 239, protect monkeys against infection by hepatitis E virus (HEV). The safety and immunogenicity of the vaccine for humans was assessed in a randomized controlled phase II clinical trial. The study was conducted in an endemic area of southern China and consisted of a dose scheduling, involving 457 adults and a dose escalation component involving 155...
This was a randomized safety/immunogenicity evaluation of PCV7 primary series at 3, 4, 5 months in healthy Chinese infants. Eight hundred subjects were randomized to Group 1 (PCV7 ≥7 days before DTaP), or Group 2 (PCV7 with DTaP), or Group 3 (DTaP only). Erythema and induration/swelling were recorded at the PCV7 injection site at any individual dose in no more than 12% and 8% of subjects, respectively,...
Recombinant hepatitis E virus capsid protein (HEV CP) assembles orally immunogenic virus-like particles (VLP) when expressed in an insect cell system. We used plant expression cassettes, pHEV101 and pHEV110, for transformation of potato to express HEV CP, and 10 independent transgenic lines of HEV101 and 6 lines of HEV110 were obtained. ELISA for HEV CP was performed on tuber extracts. Accumulation...
Hepatitis E virus (HEV) is an important causative agent of enterically-transmitted hepatitis. Successful vaccine development is crucial in controlling global HEV infection. HEV capsid protein, with 111 amino acids truncated at the N-terminus, was efficiently expressed in the baculovirus expression system [J. Virol. 71 (1997) 7207-13]. Expressed protein spontaneously assembled into virus-like particles...
We evaluated the potential of recombinant hepatitis E virus (rHEV) virus-like particles (VLPs) as an oral immunogen by analyzing the response of serum IgM, IgG, and IgA and fecal IgA in mice after oral administration. The capsid proteins of HEV with its N-terminal 111 amino acids truncated were expressed with a recombinant baculovirus in insect cells, where the capsid proteins self-assembled into...
To determine necessity and timing of booster of hepatitis B vaccine, we need to observe the duration of its protection. We report the results of a 15-year follow-up of a cohort of 649 children who participated a randomized, double blind, placebo-controlled trial on a plasma-derived hepatitis B vaccine in 1982. During the 15 years after vaccination, more vaccinated children had anti-HBs of 10 S/N ratios...
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