Immunogenicity, tolerance and reactogenicity of Quimi-Hib and alum phospate adjuvanted Quimi-Hib vaccines in healthy infants according to 6 – 10 – 14 weeks primary vaccination series. A multicenter, controlled, randomized, doubled blind clinical trial.”

开始日期2012-10-27

申办/合作机构-

100 项与 Hib vaccine conjugate(Heber Biotec SA) 相关的临床结果

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100 项与 Hib vaccine conjugate(Heber Biotec SA) 相关的转化医学

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100 项与 Hib vaccine conjugate(Heber Biotec SA) 相关的专利（医药）

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项与 Hib vaccine conjugate(Heber Biotec SA) 相关的文献（医药）

2021-09-01·Carbohydrate Research4区 · 化学

Recent chemical syntheses of bacteria related oligosaccharides using modern expeditious approaches

4区 · 化学

Review

作者: Ghosh, Rina ; Basu, Nabamita

Apart from some essential and crucial roles in life processes carbohydrates also are involved in a few detrimental courses of action related to human health, like infections by pathogenic microbes, cancer metastasis, transplanted tissue rejection, etc. Regarding management of pathogenesis by microbes, keeping in mind of multi drug-resistant bacteria and epidemic or endemic incidents, preventive measure by vaccination is the best pathway as also recommended by the WHO; by vaccination, eradication of bacterial diseases is also possible. Although some valid vaccines based on attenuated bacterial cells or isolated pure polysaccharide-antigens or the corresponding conjugates thereof are available in the market for prevention of several bacterial diseases, but these are not devoid of some disadvantages also. In order to develop improved conjugate T-cell dependent vaccines oligosaccharides related to bacterial antigens are synthesized and converted to the corresponding carrier protein conjugates. Marketed Cuban Quimi-Hib is such a vaccine being used since 2004 to resist Haemophilus influenza b infections. During nearly the past two decades research is going on worldwide for improved synthesis of bacteria related oligosaccharides or polysaccharides towards development of such semisynthetic or synthetic glycoconjugate vaccines. The present dissertation is an endeavour to encompass the recent syntheses of several pathogenic bacterial oligosaccharides or polysaccharides, made during the past ten-eleven years with special reference to modern expeditious syntheses.

2017-05-16·Accounts of Chemical Research

Advancing Homogeneous Antimicrobial Glycoconjugate Vaccines

Article

作者: Adamo, Roberto

Since 2004, when the first synthetic glycoconjugate vaccine against the pneumonia and meningitis causing bacterium Haemophilus influenza type b (Hib) approved for human use in Cuba was reported, 34 million doses of the synthetic vaccine have been already distributed in several countries under the commercial name of Quimi-Hib. However, despite the success of this product, no other synthetic glycoconjugate vaccine has been licensed in the following 13 years. As well as avoiding the need to handle pathogens, synthetic glycoconjugates offer clear advantages in terms of product characterization and the possibility to understand the parameters influencing immunogenicity. Nevertheless, large scale application of synthetic sugars has been perceived as challenging because of manufacturing costs and process complexity compared to natural polysaccharides. Chemoenzymatic approaches, one-pot protocols, and automated solid-phase synthesis are rendering carbohydrate production considerably more attractive for industrialization. Here we identify three areas where chemical approaches can advance this progress: (i) chemical or enzymatic methods enabling the delivery of the minimal polysaccharide portion responsible for an effective immune response; (ii) site-selective chemical or enzymatic conjugation strategies for the exploration of the conjugation point in immune responses against carbohydrate-based vaccines, and the consistent preparation of more homogeneous products; (iii) multicomponent constructs targeting receptors responsible for immune response modulation in order to control its quality and magnitude. We discuss how synthesis of bacterial oligosaccharides is useful toward understanding the polysaccharide portion responsible for immunogenicity, and for developing robust and consistent alternatives to natural heterogeneous polysaccharides. The synthesis of sugar analogues can lead to the identification of hydrolytically more stable versions of oligosaccharide antigens. The study of bacterial polysaccharide biosynthesis aids the development of in vitro hazard-free oligosaccharide production. Novel site-selective conjugation methods contribute toward deciphering the role of conjugation sites in the immunogenicity of glycoconjugates and prove to be particularly useful when glycans are conjugated to protein serving as carrier and antigen. The orthogonal incorporation of two different carbohydrate haptens enables the reduction of vaccine components. Finally, coordinated conjugation of glycans and small molecule immunopotentiators supports simplification of vaccine formulation and localization of adjuvant. Synergistic advancement of these areas, combined with competitive manufacturing processes, will contribute to a better understanding of the features guiding the immunological activity of glycoconjugates and, ultimately, to the design of improved, safer vaccines.

2008-01-01·Human Vaccines

Safety and immunogenicity of a combined hepatitis B virus-Haemophilus influenzaetype B vaccine comprising a synthetic antigen in healthy adults

Article

作者: Perez, L. Hernandez ; Lago-Banos, M. ; Aguilar-Betancourt, Aristides ; Rodriguez-Silva, A. ; Guillen-Nieto, G. E. ; Figueroa-Baile, N. ; Abreu-Reyes, D. ; Martinez-Cabrera, Jesus ; Olivera-Ruano, L. ; Soto-Mestre, E. ; Puble-Alvarez, N. ; Delahanty-Fernandez, A. ; Veliz-Rios, Gloria ; Gonzalez-Delgado, Carlos Alberto ; Juvier-Madrazo, A. I. ; Correa-Fernandez, A. ; Perez-Perez, M. V. ; Cinza-Estevez, Z. ; Martinez-Diaz, E. ; Ortega-Leon, D. ; Aleman-Zaldivar, Regis ; Muzio-Gonzalez, Verena L. ; Alonso-Martinez, M. I.

The combined HB-Hib vaccine candidate Hebervac HB-Hib (CIGB, La Habana), comprising recombinant HBsAg and tetanus toxoid conjugate synthetic PRP antigens has shown to be highly immunogenic in animal models. A phase I open, controlled, randomized clinical trial was carried out to assess the safety and immunogenicity profile of this bivalent vaccine in 25 healthy adults who were positive for antibody to HBsAg (anti-HBs). The trial was performed according to Good Clinical Practices and Guidelines. Volunteers were randomly allocated to receive the combined vaccine or simultaneous administration of HB vaccine Heberbiovac-HB and Hib vaccine QuimiHib (CIGB, La Habana). All individuals were intramuscularly immunized with a unique dose of 10 microg HBsAg plus 10 microg conjugated synthetic PRP. Adverse events were actively recorded after vaccine administration. Total anti-HBs and IgG anti-PRP antibody titers were evaluated using commercial ELISA kits at baseline and 30 days post-vaccination. The combined vaccine candidate was safe and well tolerated. The most common adverse reactions were local pain, febricula, fever and local erythema. These reactions were all mild in intensity and resolved without medical treatment. Adverse events were mostly reported during the first 6-72 hours post-vaccination. There were no serious adverse events during the study. No severe or unexpected events were either recorded during the trial. The combined vaccine elicited an anti-HBs and anti-PRP booster response in 100% of subjects at day 30 of the immunization schedule. Anti-HBs and anti-PRP antibody levels had at least a two-fold increase compared to baseline sera. Even more, anti-HBs antibody titer showed a four-fold increase in 100% of volunteers in the study group. The results indicate that the combined HB-Hib vaccine produces increased antibody levels in healthy adults who have previously been exposed to these two antigens. To our knowledge, this is the first demonstration of safety and immunogenicity for a combined vaccine comprising recombinant HBV and synthetic Hib antigens. The present results support phase I-II clinical trial in the target population, two months old healthy infants.

100 项与 Hib vaccine conjugate(Heber Biotec SA) 相关的药物交易

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