Safety and Immunogenicity of a Candidate Bioconjugate Vaccine Against Streptococcus Pneumoniae When Administered to Adult and Elderly Healthy Subjects. A Phase I Randomized Study.

To obtain first-in-human data on a new candidate vaccine against Streptococcus pneumoniae in healthy adult and elderly volunteers.
The study aims to assess the safety and immunogenicity of a bioconjugate investigational vaccine compared to the control group (Pneumovax23).

开始日期2017-09-07

申办/合作机构

LimmaTech Biologics AG

100 项与 Bioconjugate pneumococcal vaccine (LimmaTech Biologics) 相关的临床结果

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100 项与 Bioconjugate pneumococcal vaccine (LimmaTech Biologics) 相关的转化医学

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100 项与 Bioconjugate pneumococcal vaccine (LimmaTech Biologics) 相关的专利（医药）

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项与 Bioconjugate pneumococcal vaccine (LimmaTech Biologics) 相关的文献（医药）

2023-04-20·mSphere

The Development of Immunological Assays to Evaluate the Level and Function of Antibodies Induced by Klebsiella pneumoniae O-Antigen Vaccines

Article

作者: Osman, Guled ; Goldblatt, David ; Martin, Patricia ; Johnson, Marina ; Wagstaffe, Helen R. ; Carranza, Paula

There is no licensed vaccine for the prevention of Klebsiella pneumoniae infections, and increasing levels of antibiotic resistance make this pathogen a high priority for vaccine and therapeutic development. Standardized assays for testing vaccine immunogenicity are paramount for the development of vaccines, and so in this study, we optimized and standardized both antibody-level and function assays for evaluating in-development K. pneumoniae bioconjugate vaccine response in rabbits.

2014-05-15·The Journal of Infectious Diseases2区 · 医学

Prevention of Staphylococcus aureus Infections by Glycoprotein Vaccines Synthesized in Escherichia coli

2区 · 医学

Article

作者: Wang, Linhui ; Carranza, Paula ; Wacker, Michael ; Kowarik, Michael ; Faridmoayer, Amir ; Shields, Kelly ; Gambillara, Veronica ; Quebatte, Julien ; Dowd, Meghan ; Lee, Jean C. ; Kelley, Kathryn A. ; Steffen, Michael ; Park, Saeyoung ; Lipowsky, Gerd ; Braun, Martin ; Alaimo, Cristina

BACKGROUNDStaphylococcus aureus is a leading cause of superficial and invasive human disease that is often refractory to antimicrobial therapy. Vaccines have the potential to reduce the morbidity, mortality, and economic impact associated with staphylococcal infections. However, single-component vaccines targeting S. aureus have failed to show efficacy in clinical trials.METHODSA novel glycoengineering technology for creation of a multicomponent staphylococcal vaccine is described. Genes encoding S. aureus capsular polysaccharide (CP) biosynthesis, PglB (a Campylobacter oligosaccharyl transferase), and a protein carrier (detoxified Pseudomonas aeruginosa exoprotein A or S. aureus α toxin [Hla]) were coexpressed in Escherichia coli. Recombinant proteins N-glycosylated with S. aureus serotype 5 or 8 CPs were purified from E. coli.RESULTSRabbits and mice immunized with the glycoprotein vaccines produced antibodies that were active in vitro in functional assays. Active and passive immunization strategies targeting the CPs protected mice against bacteremia, and vaccines targeting Hla protected against lethal pneumonia. The CP-Hla bioconjugate vaccine protected against both bacteremia and lethal pneumonia, providing broad-spectrum efficacy against staphylococcal invasive disease.CONCLUSIONSGlycoengineering technology, whereby polysaccharide and protein antigens are enzymatically linked in a simple E. coli production system, has broad applicability for use in vaccine development against encapsulated microbial pathogens.

2005-01-01·Chest1区 · 医学

Antibody Production Deficiency With Normal IgG Levels in Bronchiectasis of Unknown Etiology

1区 · 医学

Article

作者: Montserrat Vendrell ; Javier de Gracia ; Marc Miravitlles ; Maria Garcia ; María-Jesús Cruz ; Antonio Alvarez ; María-José Rodrigo

BACKGROUNDNo defined cause of bronchiectasis is currently found in approximately 50% of cases. Bronchiectasis is a common long-term complication in patients with primary hypogammaglobulinemia.STUDY OBJECTIVESTo ascertain whether antibody production deficiency with normal total serum IgG levels is associated with bronchiectasis.DESIGNAntibody response to a pneumococcal unconjugate vaccine and an Haemophilus influenzae type b conjugate vaccine was prospectively studied in all consecutive adult patients with bronchiectasis of unknown etiology who were assessed in our chest outpatient clinic from January 1994 to October 2001. Serum-specific antibodies were measured by enzyme-linked immunosorbent assay, and the results were compared with those obtained in a healthy adult control group. Antibody production deficiency was defined as a failure to respond to either vaccine.RESULTSOne hundred seven patients were included in the study (mean age, 46.3 years). Antibody production deficiency was diagnosed in 12 patients (11%). A significantly higher incidence of otitis media, lower serum IgG2 subclass levels, and lower preimmunization antibody levels to Streptococcus pneumoniae and H influenzae type b were observed in patients with antibody production deficiency. The probability of antibody production deficiency in patients with a history of otitis media was 20%, 26% in those with low IgG2 subclass levels, and 58% in those with both a history of otitis media and low IgG2 subclass levels.CONCLUSIONSAntibody production deficiency with normal IgG levels may be associated with bronchiectasis, making it advisable to evaluate the antibody response to both the H influenzae and pneumococcal vaccines in patients with bronchiectasis of unknown etiology, particularly in those with a history of otitis media, low IgG2 subclass levels, and low levels of baseline specific antibodies.

100 项与 Bioconjugate pneumococcal vaccine (LimmaTech Biologics) 相关的药物交易

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