Walvax Biotechnology

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PubMed | Inc. Deer Park, Walvax Biotechnology, University of Houston and The Michael key Veterans Affairs Medical Center
Type: Journal Article | Journal: The American journal on addictions | Year: 2016

We previously reported that an anti-methamphetamine (MA) vaccine attenuated drug-conditioned effects in mice, but it used a carrier protein and adjuvant not available for clinical use. Here we produced a vaccine with the same hapten (succinyl-methamphetamine, SMA) but attached to tetanus toxoid (SMA-TT) and adsorbed to aluminum hydroxide, components approved for use in humans. We then assessed the vaccines ability to generate anti-MA antibodies, alter acquisition and reinstatement of MA place conditioning, and prevent MA brain penetration.Mice were administered SMA-TT at weeks 0 and 3 and non-vaccinated mice received saline. Anti-MA antibody concentrations were determined at 8 and 12 weeks. Place conditioning began during week 9 in which vaccinated and non-vaccinated mice were divided into groups and conditioned with .5, or 2.0mg/kg MA. Following acquisition training, mice were extinguished and then a reinstatement test was performed in which mice were administered their original training dose of MA. Separate groups of non-vaccinated and vaccinated mice were administered .5 and 2.0mg/kg MA and brain MA levels determined.Anti-MA antibody levels were elevated at week 8 and remained so through week 12. The SMA-TT vaccine attenuated acquisition and reinstatement of MA place conditioning. Significantly greater proportions of vaccinated mice during acquisition and reinstatement tests showed conditioned place aversion. Moreover, MA brain levels were decreased in vaccinated mice following administration of both doses of MA.Results support further development of anti-MA vaccines using components approved for use in humans.


PubMed | Walvax Biotechnology, Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, PLA Fourth Military Medical University, Centers for Disease Control and Prevention and Beijing Chaoyang District Center for Disease Control and Prevention
Type: Journal Article | Journal: BMJ open | Year: 2016

The invasive pneumococcal diseases (IPDs) caused by Streptococcus pneumoniae pose an enormous threat to children under 5years of age. However, routine use of pneumococcal conjugate vaccines could aid in reducing the incidence of IPDs. The purpose of this clinical trial is to assess the non-inferiority of the investigational 13-valent pneumococcal conjugate vaccine (PCV13) to the currently licensed 7-valent pneumococcal conjugate vaccine (PCV7).1040 infants will receive a three-dose series of either PCV13 or PCV7 at ages 3, 4 and 5months, respectively, and a booster dose at 12-15months. Primary end points are the percentage of participants reaching a serotype-specific IgG concentration of 0.35g/mL and the IgG antibody geometric mean concentrations (GMCs) measured 30days after the primary immunisation. Secondary end points include the percentage of vaccine recipients reaching a serotype-specific IgG concentration threshold of 1.0g/mL, the percentage of participants reaching the pneumococcal opsonophagocytic assay (OPA) titre threshold of 1:8, and the geometric mean titres (GMTs) of OPA measured 30days after primary and booster doses. The number of standard IgG responders and IgG GMCs measured 30days after the booster immunisation will also be determined. To evaluate differences between two groups, the sequential testing of the non-inferiority of PCV13 for the seven common serotypes and its effectiveness in treating the six additional serotypes will be performed.Ethics approvals have been granted by the Ethics Committees at the three provinces involved in this study: Shanxi, Henan and Hebei. The trial will be reported in accordance with the CONSORT guidance.NCT02736240.


Chen B.,Chinese University of Hong Kong | Gu T.,Centers for Disease Control and Prevention | Ma B.,Walvax Biotechnology | Zheng G.,Yunnan Guandu Prison | And 8 more authors.
Journal of Molecular Neuroscience | Year: 2014

Accumulating evidence suggests that the hypothalamic-pituitary-adrenal (HPA) axis might play a major role in genetic susceptibility of aggressive behavior. The aim of the present study is to investigate the association between corticotrophin-releasing hormone receptor 1 (CRHR1) gene and aggressive behavior in Chinese southwest Han population. Participants consist of 282 healthy controls and 177 violent criminals (including robbery and intentional injury, which represent for aggressive behavior towards property and aggressive behavior towards others). Three tag single nucleotide polymorphisms (SNPs) of CRHR1 gene including rs4458044, rs242924, and rs1768996 were genotyped using improved multiplex ligase detection reaction (iMLDR) methods. Single-locus analysis revealed that none of the studied SNPs was significantly associated with the risk of aggressive behavior; however, haplotype analysis showed that a haplotype GGA significantly increased the susceptibility of aggressive behavior towards others with an odds ratios equal to 3.32 (p = 0.003). The present results, for the first time, indicate that the CRHR1 gene polymorphism is significantly associated with aggressive behavior in Chinese southwest Han population. Subjects with GGA haplotype have an increased susceptibility to aggressive behavior towards others. © 2013 Springer Science+Business Media.


PubMed | Chinese University of Hong Kong, Walvax Biotechnology, Changsha Medical University and Kunming Medical University
Type: Journal Article | Journal: Genetics and molecular research : GMR | Year: 2014

In this study, we investigated the association between 5 interferon regulatory factor-5 (IRF5) single nucleotide polymorphisms (SNPs) and autoimmune diseases using the Medline citation index. Twenty-eight studies with 74 comparisons, including 16 rheumatoid arthritis (RA), 43 systemic lupus erythematous (SLE), 2 juvenile idiopathic arthritis (JIA), 6 multiple sclerosis (MS), and 5 systemic sclerosis (SSc) studies, were examined in the meta-analysis. The SNP rs2004640 was significantly associated with SLE, MS, and SSc, but not with JIA [odds ratio (OR)=1.06, 95% confidence interval (CI)=0.90-1.24, P=0.48] or RA (OR=1.03, 95%CI=0.95-1.11, P=0.44). A significant association was observed between rs2280714 and SLE, MS, and SSc, but not RA (OR=1.01, 95%CI=0.94-1.09, P=0.80). Rs10954213 was associated with the pathogenesis of SLE, RA, MS, and SSc. rs2070197 and the exon 6 insertion were significantly associated with SLE. Haplotypes containing rs2004640T and rs2280714T were significantly associated with an increased risk of SLE, but not with RA. This meta-analysis certified that IRF5 polymorphisms confer susceptibility to SLE, MS, and SSc. To further confirm the correlations between polymorphisms of IRF5 and autoimmune disease susceptibility, studies involving a larger number of patients worldwide are necessary.


Tang L.,Changsha Medical University | Chen B.,Chinese University of Hong Kong | Ma B.,Walvax Biotechnology | Nie S.,Kunming Medical University
Genetics and Molecular Research | Year: 2014

In this study, we investigated the association between 5 interferon regulatory factor-5 (IRF5) single nucleotide polymorphisms (SNPs) and autoimmune diseases using the Medline citation index. Twenty-eight studies with 74 comparisons, including 16 rheumatoid arthritis (RA), 43 systemic lupus erythematous (SLE), 2 juvenile idiopathic arthritis (JIA), 6 multiple sclerosis (MS), and 5 systemic sclerosis (SSc) studies, were examined in the meta-analysis. The SNP rs2004640 was significantly associated with SLE, MS, and SSc, but not with JIA [odds ratio (OR) = 1.06, 95% confidence interval (CI) = 0.90-1.24, P = 0.48] or RA (OR = 1.03, 95%CI = 0.95-1.11, P = 0.44). A significant association was observed between rs2280714 and SLE, MS, and SSc, but not RA (OR = 1.01, 95%CI = 0.94-1.09, P = 0.80). Rs10954213 was associated with the pathogenesis of SLE, RA, MS, and SSc. rs2070197 and the exon 6 insertion were significantly associated with SLE. Haplotypes containing rs2004640T and rs2280714T were significantly associated with an increased risk of SLE, but not with RA. This meta-analysis certified that IRF5 polymorphisms confer susceptibility to SLE, MS, and SSc. To further confirm the correlations between polymorphisms of IRF5 and autoimmune disease susceptibility, studies involving a larger number of patients worldwide are necessary. © FUNPEC-RP.


Chen Y.-Q.,Walvax Biotechnology | Zhang M.-F.,Walvax Biotechnology | He J.-D.,Walvax Biotechnology | Tao J.-M.,Walvax Biotechnology | And 4 more authors.
Chinese Journal of Biologicals | Year: 2014

Objective: To investigate the immunogenicity of group Y meningococcal polysaccharide (MenYPS)-protein conjugate vaccine using avirulent mutant CRM197 of natural diphtheria toxoid and tetanus toxoid (TT) as carriers in mice. Methods: MenYPS was derived with 1, 6-adipic acid dihydrazide (ADH) to prepare derivative MenYPS-ADH which was covalently bound to CRM197 and TT in mediation of N-(3-dimethylaminoprophyl)-N′-ethylcarbodiimide hydrochloride (EDAC) to prepare three batches of MenYPS-CRM 197 and MenYPS-TT conjugates respectively. The serogroup-specificity of polysaccharide antigen in the conjugates was determined by double immunodiffusion test in agar. BALB/c mice were injected s. c. with the prepared derivates and conjugates, 2.5 μ.g for each, on days 0, 14 and 28 separately. Serum samples were collected on days 7, 29 and 35, and determined for GMTs of antibodies. Sterility and abnormal toxicity tests were performed according to the Chinese Requirements for Biologics (2000 edition). Results: The prepared three batches of MenYPS-CRM197 and MenYPS-TT conjugates formed precipitation lines with diagnostic serum for MenYPS, both of which induced high antibody titer in mice. However, the GMTs of antibodies in sera of mice after immunization with the 2nd and the 3rd doses of MenYPS-TT and MenYPS-CRM197 showed no significant difference (each P > 0.05), both of which were significantly higher than those with MenYPS-ADH (each P < 0.05). The GMTs of mice after immunization with the 2nd dose of MenYPS-TT and MenYPS-CRM197 were significantly higher than those after the 1st dose, while after the 3rd dose than after the 2nd dose (each P < 0.01). The result of sterility test met the Chinese Requirements for Biologics (2000 edition). In abnormal toxicity test, no abnormal reaction or death was observed in the guinea pigs and mice during an observation period of 7 d, while the bodyweights were gained. Conclusion: Both MenYPS and CRM197 conjugates induced high antibody titer and immune memory in BALB/c mice.


Trademark
Walvax Biotechnology | Date: 2012-03-20

Bacteriostats for medicinal, dental and veterinary use; Biocides; Biological tissue cultures for veterinary purposes; Chemical reagents for medical or veterinary purposes; Depuratives for the body; Dietetic foods adapted for medical purposes; Fillings for teeth; Pharmaceutical preparation for skin care; Pharmaceutical preparations for ocular or intraocular surgery; Pharmaceutical preparations for wounds; Pharmaceutical products for the prevention and treatment of cancer; Surgical tissues; Vaccines. Biological research; Chemical research; Design services for packaging; Dress design services; Material testing; Programming of computer software for others; Surveying; Technical research in the field of aeronautics; Weather forecasting.


Trademark
Walvax Biotechnology | Date: 2012-03-20

Bacteriostats for medicinal, dental and veterinary use; Biocides; Biological tissue cultures for veterinary purposes; Chemical reagents for medical or veterinary purposes; Depuratives for the body; Dietetic foods adapted for medical purposes; Fillings for teeth; Pharmaceutical preparation for skin care; Pharmaceutical preparations for ocular or intraocular surgery; Pharmaceutical preparations for wounds; Pharmaceutical products for the prevention and treatment of cancer; Surgical tissues; Vaccines. Biological research; Chemical research; Design services for packaging; Dress design services; Material testing; Programming of computer software for others; Surveying; Technical research in the field of aeronautics; Weather forecasting.


NEW YORK--(BUSINESS WIRE)--Medidata (NASDAQ: MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced that its industry-leading technology platform has been adopted by Walvax Biotechnology Co., Ltd (“Walvax”) (SZSE: 300142), a biopharmaceutical company in China. Walvax is harnessing the Medidata Clinical Cloud® platform to improve data management activities and drive biomedical innovation in the development of a pneumococcal conjugate vaccine for infants. “Pneumococcal infections—including pneumonia, blood infections and meningitis—can be extremely difficult to treat, making prevention through vaccination a critical component of patient care,” said Yi Zhang, Vice President, Walvax. “We’re pleased to be using Medidata’s robust, globally-validated technology to bring greater speed and operational efficiencies to our pneumococcal conjugate vaccine trials, ultimately leading to a safe and effective way to ensure young children are protected from the devastating effects of pneumococcal diseases.” Founded in 2001, Walvax Biotechnology specializes in the research, development, production and distribution of bio-medicine products, including vaccines and blood products. To optimize the execution of its novel research on a vaccine for pneumococcal conjugate (PCV13)—the first multi-center clinical trials to be conducted on infants and toddlers in China—Walvax is utilizing Medidata’s cloud-based technology for electronic data capture and management (Medidata Rave®). The Chinese biopharmaceutical company is also leveraging training available through Medidata’s professional services offering to speed study implementation and ensure trial timelines are met. "Medidata's cloud-based platform is designed to bring efficiencies to clinical trials of all sizes and therapeutics areas," said Takeru Yamamoto, Medidata’s managing director of the Asia-Pacific (APAC) region. "We’re proud to be collaborating with Walvax as the organization advances pneumococcal conjugate vaccine research in China, resulting in better preventative treatment for young people around the world." Walvax Biotechnology Co., Ltd. (“Walvax”) was founded in 2001, which is a modern biological pharmaceutical enterprise engaged in R & D, production and sales of bio-medicine products. Walvax is a National Validated High-tech Enterprise and Enterprise Technical Center. In November, 2010, Walvax Biotechnology Co., Ltd. (stock name: Walvax Biotech, and stock code: 300142) listed on Shenzhen Stock Exchange. Walvax is committed to provide safe bio-medicine (such as vaccines, blood products and so on) with excellent quality and advanced technology for domestic and foreign markets. Walvax’s headquarters is located in Kunming, Yunnan Province of China. Walvax has a staff of more than 1,200, and has a modern R&D center in National High-tech Zone of Kunming, and a modern vaccine production base and pilot base in High-tech Zone of Yunnan Yuxi and Jiangsu Taizhou China Medical City, respectively. Walvax’s marketing network covers 30 provinces and cities of China, which includes more than 2,000 counties. Medidata is the leading global provider of cloud-based solutions for clinical research in life sciences, transforming clinical development through its advanced applications and intelligent data analytics. The Medidata Clinical Cloud® brings new levels of productivity and quality to the clinical testing of promising medical treatments, from study design and planning through execution, management and reporting. We are committed to advancing the competitive and scientific goals of global customers, which include over 90% of the top 25 global pharmaceutical companies; innovative biotech, diagnostic and device firms; leading academic medical centers; and contract research organizations.

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