Szu S.C.,U.S. National Institutes of Health |
Hunt S.,U.S. National Institutes of Health |
Xie G.,Lanzhou Institute of Biological Products |
Robbins J.B.,U.S. National Institutes of Health |
And 4 more authors.
Vaccine | Year: 2013
Recent data showing the high incidence of typhoid fever in young children, the demonstration of safety and efficacy of a Vi conjugate for this age group, the safety and similar immunogenicity in infants when administrated concurrently with EPI vaccines, together with the interests of manufacturers and investigators in studying such conjugate vaccines prompted us to prepare a human IgG anti-Vi standard to facilitate this work. Volunteers were injected with an investigational Vi-recombinant Pseudomonas aeruginosa exoprotein A (Vi-. rEPA) conjugate vaccine. Plasmas with the highest levels of IgG anti-Vi were pooled. The IgG anti-Vi content of this preparation, assayed by precipitin analysis with purified Vi, was 33. μg/ml. Accordingly, the estimated IgG anti-Vi protective level of 3.5 ELISA unit/ml, derived from our efficacy trial of Vi-rEPA in 2-5 years old children, is equivalent to 4.3. μg/ml. This reagent is suitable for comparison of immune response of Vi conjugate vaccines or for other purposes requiring anti-Vi measurement. © 2013 .
PubMed | Pfizer, FDA CBER, GSK Vaccines, Lanzhou Institute of Biological Products and 5 more.
Type: | Journal: Clinical and vaccine immunology : CVI | Year: 2016
Opsonophagocytic assays (OPAs) are routinely used for assessing the immunogenicity of pneumococcal vaccines, with OPA data often utilized for licensure of new vaccine formulations. However, no reference serum for pneumococcal OPAs is available, making evaluation of data among different laboratories difficult. This international collaboration was initiated to: 1) assign consensus opsonic indexes (OIs) to Pneumococcal Reference Serum Lot 007sp (007sp) and a panel of calibration sera; and 2) determine if normalization with 007sp decreases the OPA variability among laboratories.To meet these goals, six participating laboratories tested a panel of sera in five runs for 13 serotypes. For each serum, consensus OIs were obtained using a mixed effects ANOVA model. For the calibration sera, normalized consensus values were also determined based on 007sp.For each serotype, the overall reduction in inter-laboratory variability was calculated by comparing the coefficients of variation of the unadjusted and the normalized values. Normalization of the results substantially reduced the inter-laboratory variability, ranging from a 15% reduction in variability for serotype 9V to 64% for serotype 7F. Normalization also increased the proportion of data within 2-fold of the consensus value from approximately 70% (average of all serotypes) to >90%.Based on the data obtained in this study, Pneumococcal Reference Standard Lot 007sp will likely be a useful reagent for normalizing pneumococcal OPA results from different laboratories. The data also support the use of the 16 FDA OPA calibration sera as part of the initial evaluation of new assays or periodic assessment of established assays.
Liang X.-F.,U.S. Center for Disease Control and Prevention |
Wang H.-Q.,U.S. Center for Disease Control and Prevention |
Wang J.-Z.,National Institute for the Control of Pharmaceuticals and Biological Products |
Fang H.-H.,National Institute for the Control of Pharmaceuticals and Biological Products |
And 19 more authors.
The Lancet | Year: 2010
Background: The current influenza pandemic calls for a safe and effective vaccine. We assessed the safety and immunogenicity of eight formulations of 2009 pandemic influenza A H1N1 vaccine produced by ten Chinese manufacturers. Methods: In this multicentre, double-blind, randomised trial, 12 691 people aged 3 years or older were recruited in ten centres in China. In each centre, participants were stratified by age and randomly assigned by a random number table to receive one of several vaccine formulations or placebo. The study assessed eight formulations: split-virion formulation containing 7·5 μg, 15 μg, or 30 μg haemagglutinin per dose, with or without aluminium hydroxide adjuvant, and whole-virion formulation containing 5 μg or 10 μg haemagglutinin per dose, with adjuvant. All formulations were produced from the reassortant strain X-179A (A/California/07/2009-A/PR/8/34). We analysed the safety (adverse events), immunogenicity (geometric mean titre [GMT] of haemagglutination inhibition antibody), and seroprotection (GMT ≥1:40) of the formulations. Analysis was by per protocol. Two sites registered their trial with ClinicalTrials.gov, numbers NCT00956111 and NCT00975572. The other eight studies were registered with the State Food and Drug Administration of China. Findings: 12 691 participants received the first dose on day 0, and 12 348 participants received the second dose on day 21. The seroprotection rate 21 days after the first dose of vaccine ranged from 69·5% (95% CI 65·9-72·8) for the 7·5 μg adjuvant split-virion formulation to 92·8% (91·9-93·6) for the 30 μg non-adjuvant split-virion formulation. The seroprotection rate was 86·5% (796 of 920; 84·1-88·7) in recipients of one dose of the 7·5 μg non-adjuvant split-virion vaccine compared with 9·8% (140 of 1432; 8·3-11·4) in recipients of placebo (p<0·0001). One dose of the 7·5 μg non-adjuvant split-virion vaccine induced seroprotection in 178 of 232 children (aged 3 years to <12 years; 76·7%, 70·7-82·0), 211 of 218 adolescents (12 years to <18 years; 96·8%, 93·5-98·7), 289 of 323 adults (18-60 years; 89·5%, 85·6-92·6), and 118 of 147 adults older than 60 years (80·3%, 72·9-86·4), meeting the European Union's licensure criteria for seroprotection in all age-groups. In children, a second dose of the 7·5 μg formulation increased the seroprotection rate to 97·7% (215 of 220, 94·8-99·3). Adverse reactions were mostly mild or moderate, and self-limited. Severe adverse effects occurred in 69 (0·6%, 0·5-0·8) recipients of vaccine compared with one recipient (0·1%, 0-0·2) of placebo. The most common severe adverse reaction was fever, which occurred in 25 (0·22%; 0·14-0·33) recipients of vaccine after the first dose and four (0·04%; 0·01-0·09) recipients of vaccine after the second dose compared with no recipients of placebo after either dose. Interpretation: One dose of non-adjuvant split-virion vaccine containing 7·5 μg haemagglutinin could be promoted as the formulation of choice against 2009 pandemic influenza A H1N1 for people aged 12 years or older. In children (aged <12 years), two 7·5 μg doses might be needed. Funding: Sinovac Biotech, Hualan Biological Bacterin, China National Biotec Group, Beijing Tiantan Biological Products, Changchun Institute of Biological Products, Changchun Changsheng Life Sciences, Jiangsu Yanshen Biological Technology Stock, Zhejiang Tianyuan Bio-Pharmaceutical, Lanzhou Institute of Biological Products, Shanghai Institute of Biological Products, and Dalian Aleph Biomedical. © 2010 Elsevier Ltd. All rights reserved.
News Article | December 9, 2016
— Intended Audience o DPT vaccine manufacturers o DPT vaccine Suppliers o Contract Research Organizations (CROs) o Research and Development (R&D) Companies o Government Research Laboratories o Independent Research Laboratories o Government and Independent Regulatory Authorities o Market Research and Consulting Service Providers o Medical Research Laboratories o Academic Medical Institutes and Universities Market Scenario: Globally the market for DPT vaccine is increasing rapidly. The major factor that derives the growth of DPT vaccine is the increasing deaths in children due to pertussis. Furthermore increasing awareness for DPT vaccines is increasing the growth of DPT Vaccine Market. Globally the market for DPT vaccine market is expected to grow at the rate of about XX% CAGR from 2016 to 2027. Key Players for DPT vaccine Market: • Merck & Co., Inc (U.S) • Sanofi (France) • GSK (U.S) • Lanzhou Institute of Biological Products (China) • wyeth (U.S) • Chiron Pharmaceutical Pvt Ltd (India) Segments Global DPT vaccine market has been segmented on the basis of type which comprises of DPaT, DTwP and Tdap. On the basis of applications include diphtheria, pertussis and tetanus. Regional Analysis of DPT vaccine Market: Globally North America is the largest market for DPT vaccine. The North American market for DPT vaccine is expected to grow at a CAGR of XX% and is expected to reach at US$ XXX Million by the end of the forecasted period. This is due to increasing number of deaths of children in the country. Europe is the second-largest market for DPT vaccine which is expected to grow at a CAGR of XX%. Furthermore Asia pacific market is expected to be the growing market for DPT vaccine market. Taste the market data and market information presented through more than 70 market data tables and figures spread in 115 numbers of pages of the project report. Avail the in-depth table of content TOC & market synopsis on “Global DPT Vaccine Market Research Report- Forecast To 2027” Study Objectives of DPT vaccine Market: o To provide detailed analysis of the market structure along with forecast for the next 10 years of the various segments and sub-segments of the DPT vaccine market o To provide insights about factors affecting the market growth o To analyze the DPT Vaccine Market based on various factors- price analysis, supply chain analysis, porters five force analysis etc. o To provide historical and forecast revenue of the market segments and sub-segments with respect to four main geographies and their countries- Americas, Europe, Asia-Pacific, and Middle East & Africa. o To provide country level analysis of the market with respect to the current market size and future prospective o To provide country level analysis of the market for segments by type, by applications and its sub-segments. o To provide overview of key players and their strategic profiling in the market, comprehensively analyzing their core competencies, and drawing a competitive landscape for the market o To track and analyze competitive developments such as joint ventures, strategic alliances, mergers and acquisitions, new product developments, and research and developments in the global Table of Content 1. Report Prologue 2. Introduction 2.1 Definition 2.2 Scope of the Study 2.2.1 Research Objective 2.2.2 Assumptions 2.2.3 Limitations 2.3 Market Structure 2.4. Market Segmentation 3. Research Methodology 3.1 Research Process 3.2 Primary Research 3.3 Secondary Research 3.4 Market Size Estimation 3.5 Forecast Model 4. Market Dynamics 4.1 Drivers 4.2 Restraints 4.3 Opportunities 4.4 Mega Trends 4.5 Macroeconomic Indicators 5. Market Factor Analysis 5.1 Value Chain Analysis 5.2 Porters Five Forces 5.3 Demand & Supply: Gap Analysis 5.4 Pricing Analysis 5.5 Investment Opportunity Analysis 5.6 Merger and Acquisition Landscape 5.7 Up-Coming Trends In Global DPT Vaccine Market 5.7.1 Market Trends 5.7.2 Technological Trends Continue………. Get Full TOC with List of Tables & Figures @ http://www.marketresearchfuture.com/request-toc/global-dpt-vaccine-market-research-report-forecast-to-2027 The report for Global DPT Vaccine Market of Market Research Future comprises of extensive primary research along with the detailed analysis of qualitative as well as quantitative aspects by various industry experts, key opinion leaders to gain the deeper insight of the market and industry performance. The report gives the clear picture of current market scenario which includes historical and projected market size in terms of value and volume, technological advancement, macro economical and governing factors in the market. The report provides details information and strategies of the top key players in the industry. The report also gives a broad study of the different markets segments and regions Related Report Ulnar Nerve Treatment Market Information, by Types of treatments (OTC pain relievers, nerve spasm drugs, physical therapy, surgery) by end users (Hospitals and Clinics, Research Centers, laboratories) - Forecast to 2022 https://www.marketresearchfuture.com/reports/ulnar-nerve-treatment-market-research-report-global-forecast-to-2022 About Market Research Future: At Market Research Future (MRFR), we enable our customers to unravel the complexity of various industries through our Cooked Research Report (CRR), Half-Cooked Research Reports (HCRR), Raw Research Reports (3R), Continuous-Feed Research (CFR), and Market Research & Consulting Services. For more information, please visit http://www.marketresearchfuture.com/reports/global-dpt-vaccine-market-research-report-forecast-to-2027
PubMed | Massachusetts Institute of Technology, Johns Hopkins University, Lanzhou Institute of Biological Products, Lanzhou University and 2 more.
Type: Journal Article | Journal: PloS one | Year: 2015
Effective tuberculosis (TB) vaccine should target tubercle bacilli with various metabolic states and confer long-term protective immunity. In this study, we constructed a novel multi-stage TB subunit vaccine based on fusion protein ESAT6-Ag85B-MPT64(190-198)-Mtb8.4-HspX (LT69 for short) which combined early expressed antigens and latency-associated antigen. The fusion protein was mixed with an adjuvant being composed of N, N-dimethyl-N, N-dioctadecylammonium bromide (DDA) and polyriboinosinic polyribocytidylic acid (PolyI:C) to construct subunit vaccine, whose immunogenicity and protective ability were evaluated in C57BL/6 mice. The results showed that LT69 had strong immunogenicity and high protective effect against Mycobacterium tuberculosis (M. tuberculosis) H37Rv aerosol challenge. Low-dose (2 g) of LT69 generated long-term immune memory responses and provided effective protection, which was even higher than traditional vaccine BCG did at 30 weeks post the last vaccination. In conclusion, multistage subunit vaccine LT69 showed high and long-term protection against M. tuberculosis infection in mice, whose effect could be enhanced by using a relative low dosage of antigen.
Xue L.,Capital Medical University |
Yao K.,Capital Medical University |
Xie G.,Lanzhou Institute of Biological Products |
Zheng Y.,Shenzhen Childrens Hospital |
And 13 more authors.
Clinical Infectious Diseases | Year: 2010
A total of 171 Streptococcus pneumoniae isolates causing invasive disease were isolated from Chinese children. The serotype distribution and antimicrobial resistance were tested. The results suggested that the 7-valent pneumococcal conjugate vaccine has a preventive effect among children and that there should be long-term surveillance for serotype 19A. © 2010 by the Infectious Diseases Society of America. All rights reserved.
Li W.,Lanzhou Institute of Biological Products
Chinese Journal of Biologicals | Year: 2010
Objective: To isolate and identify enterovirus 71(EV71) Lanzhou01 strain, analyze its biological characteristics and lay a foundation of screening candidate virus strain of EV71 vaccine. Methods: EV71 Lanzhou01 strain was isolated from the fecal specimens of patients with hand-foot-and mouth disease in Lanzhou City, China for plaque cloning and subculture, then determined for specificity by RT-PCR and for virulence by Vero cell methyl cellulose plaque method. The VP1 gene of the isolated strain was cloned and sequenced, the virulence was determined, and the morphology was observed by scanning electron microscopy. The strain was inoculated to Vero cells at various MOIs, and the CPEs were observed, based on which a virus proliferation curve was plotted. The isolated strain was subcultured continuously and analyzed for VP1 gene and amino acid sequences to evaluate the genetic stability. Results: A isolated strain was obtained by subculture in cells and plaque cloning, of which the RT-PCR product showed a specific band at length of about 250 bp on 1% agarose gel electrophoretic profile. The strain was identified as EV71 of C4 subtype by VP1 gene sequencing and phylogenetic analysis, of which the homologies of nucleotides to the isolated EV71 strains in other regions including Zhejiang and Shenzhen were not less than 99%. The virus particles under electron microscope were in spherical forms, at diameters of 20-30 nm. The strain caused typical CPE of Vero cells, of which the virulence was 6. 8 LgPFU/ml. After subculture in Vero cells for 30 passages, the nucleotide homologies of VP1 gene of various passages were more than 99. 6%. However, no significant variation of amino acid sequence or significant change of virulence was observed. Conclusions: An EV71 strain with good biological characteristics was isolated, which laid a foundation of developing inactivated vaccine and screening candidate vaccine virus strain.
Li P.,Lanzhou Institute of Biological Products
Xi bao yu fen zi mian yi xue za zhi = Chinese journal of cellular and molecular immunology | Year: 2011
To prepare the monoclonal antibody (mAb)against Pfs25 protein of Plasmodium falciparum, and establish the method of sandwich ELISA for detecting the Pfs25 protein. Pfs25 protein the recombinant expressed by Pichia pastoris was purified. The purified Pfs25 protein as the antigen was used to immune the BALB/c mice, The secreting specific mAb positive cell strains, which were prepared by hybridizing the Sp2/0 myeloma cell and the spleen cell from immunized mice, were detected by indirect ELISA method. The ascites of mAb were collected from immunization F1 mice, and their biological properties were identified by indirect ELISA. The anti-Pfs25 antibody was labeled by Horseradish Peroxidase (HRP), the sandwich ELISA method to detect Pfs25 protein was established based on the anti-Pfs25 mAb 4B7 and 1B4 as coating and enzyme antibody, respectively. Three hybridoma cell lines secreting mAb against Pfs25 protein have been selected from the antibody positive hybridizing cells. The two of them have a better stability and specificity. The sandwich ELISA method detecting Pfs25 protein was established. Its detecte range was 0.07-1 mg/mL , and its sensitivity was 41.6 ng/mL. The anti-Pfs25 mAb are successfully prepared and the double antibody sandwich ELISA method detecting Pfs25 protein is established. Our study lay a foundation of developing transmission-blocking malaria vaccine with Pfs25 protein as antigen.
Qiao R.-J.,Lanzhou Institute of Biological Products
Chinese Journal of Biologicals | Year: 2011
Objective: To develop a serum bactericidal assay(SBA) in vitro for determination of bactericidal activity of serum anti-Haemophilus influenzae type b (Hib) polyribosylribitol phosphate (PRP) antibody. Methods: A SBA method was developed by screening of complement and index bacterial strain, and verified for stability, specificity and precision. Results Hib-EAGAN strain as an index strain and Hib-positive serum showed high bactericidal specificity, of both of which the non-specific bactericidal rates were 0. of the four batches of complements provided by Pel-Freez, Lot 17830 showed high stability and specificity. The result of verification showed high stability and specificity of the developed Hib-SBA system, of which the CV of precision was 16%-28%. Conclusion: The SBA in vitro for determination of bactericidal activity of serum anti-Hib-PRP was successfully developed, which was of high-throughput, was time-saving and easy to be standardized.
Hu L.-N.,Lanzhou Institute of Biological Products
Chinese Journal of Biologicals | Year: 2011
Objective: To develop a stable and effective procedure for fermentation of recombinant Yersinia pestis and purification of LcrV antigen. Methods: The regularity of growth of recombinant E. coli strain pET-V/BL21 (DE3) in tube and in conical flask as well as expression of LcrV antigen were investigated, based on which the medium, time point and duration for induction with IPTG and IPTG concentration were optimized and scaled up to a 30 L fermenter to develop a stable fermentation procedure. The harvested bacteria were subjected to freeze-thawing, from which protein solution was collected by centrifugation and treated by high pressure homogenization, the purified by Q. Sepharose HP anion exchange chromatography, Phenyl Sepharose 6 FF (hs) hydrophobic chromatography and Superdex 75 pg gel filtration chromatography, based on which a stable purification procedure was developed. Three consecutive batches of test samples were purified by the developed procedure and subjected to overall control tests according to the requirements in Chinese Pharmacopoeia (Volume III, 2010 edition). Results: After culture and induction under the optimized condition, the density of harvested bacteria (A 600 value) reached 34, while the expression level and amount of LcrV antigen reached were more than 36% and 1.6 g/L respectively. After purification by column chromatography, the yield, purity and total recovery rate of LcrV antigen were more than 140 mg, more than 95% and more than 8.5% respectively. All the quality indexes of purified LcrV antigen met the requirements in Chinese Pharmacopoeia (Volume III, 2010 edition). Conclusion: A stable procedure suitable for large-scale production of LcrV antigen was developed, which laid a foundation of preparation of novel Y. pestis component vaccine.