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Phase I study of a Neisseria meningitidis liposomal vaccine containing purified outer membrane proteins and detoxified lipooligosaccharide

Highlights ► Immunogenicity of outer membrane proteins not enhanced by combining with liposomes. ► Liposomes were an effective formulation for the presentation of lipooligosaccharides. ► Truncated L8-5 LOS induced antibodies bactericidal for strains with full length LOS. ► The strongest bactericidal... Full description

Journal Title: Vaccine
Main Author: Zollinger, Wendell D.
Other Authors: Babcock, Janiine G. , Moran, Elizabeth E. , Brandt, Brenda L. , Matyas, Gary R. , Wassef, Nabila M. , Alving, Carl R.
Format: Electronic Article Electronic Article
Language: English
Subjects:
ID: ISSN: 0264-410X ; DOI: 10.1016/j.vaccine.2011.11.084
Link: http://dx.doi.org/10.1016/j.vaccine.2011.11.084
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recordid: sciversesciencedirect_elsevierS0264-410X(11)01880-9
title: Phase I study of a Neisseria meningitidis liposomal vaccine containing purified outer membrane proteins and detoxified lipooligosaccharide
format: Article
creator:
  • Zollinger, Wendell D.
  • Babcock, Janiine G.
  • Moran, Elizabeth E.
  • Brandt, Brenda L.
  • Matyas, Gary R.
  • Wassef, Nabila M.
  • Alving, Carl R.
subjects:
  • Neisseria Meningitidis
  • Vaccine
  • Liposome
  • Lipooligosaccharide
  • Human
ispartof: Vaccine
description: Highlights ► Immunogenicity of outer membrane proteins not enhanced by combining with liposomes. ► Liposomes were an effective formulation for the presentation of lipooligosaccharides. ► Truncated L8-5 LOS induced antibodies bactericidal for strains with full length LOS. ► The strongest bactericidal antibody response was induced by the L8-5 LOS. Purified outer membrane proteins and purified deacylated lipooligosaccharide (dLOS) were formulated for use as a vaccine in three formulations for clinical use. The three vaccine formulations included (1) purified outer membrane proteins (OMPs) and L8-5 dLOS adsorbed to aluminum hydroxide; (2) purified OMPs and L8-5 dLOS incorporated into liposomes; and (3) purified OMPs and L7 dLOS incorporated into proteoliposomes. The vaccines were compared for immunogenicity and safety in a phase 1clinical study. Ten adult volunteers were vaccinated with each of the three vaccine formulations. Two 50 μg doses were given six weeks apart, and serum samples were obtained at 0, 2, 6, 8 and 14 weeks. Volunteers were evaluated for reactogenicity 30 min after vaccination and at days 1, 2, and 14 after each vaccination, and laboratory safety tests were done at 0, 2 and 6 weeks. Overall, the vaccines were well tolerated. Bactericidal assays against a homologous strain showed a four-fold or greater increase in titer in 6 of 7 volunteers in group one, 9 of 10 volunteers in group two, and 5 of 10 volunteers in group three. A quantitative enzyme linked immunosorbant assay showed increases in antibody against both OMPs and LOS antigens. The liposome formulation appeared to be particularly effective in presenting the dLOS as an antigen.
language: eng
source:
identifier: ISSN: 0264-410X ; DOI: 10.1016/j.vaccine.2011.11.084
fulltext: fulltext
issn:
  • 0264410X
  • 0264-410X
url: Link


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titlePhase I study of a Neisseria meningitidis liposomal vaccine containing purified outer membrane proteins and detoxified lipooligosaccharide
creatorZollinger, Wendell D. ; Babcock, Janiine G. ; Moran, Elizabeth E. ; Brandt, Brenda L. ; Matyas, Gary R. ; Wassef, Nabila M. ; Alving, Carl R.
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subjectNeisseria Meningitidis ; Vaccine ; Liposome ; Lipooligosaccharide ; Human
descriptionHighlights ► Immunogenicity of outer membrane proteins not enhanced by combining with liposomes. ► Liposomes were an effective formulation for the presentation of lipooligosaccharides. ► Truncated L8-5 LOS induced antibodies bactericidal for strains with full length LOS. ► The strongest bactericidal antibody response was induced by the L8-5 LOS. Purified outer membrane proteins and purified deacylated lipooligosaccharide (dLOS) were formulated for use as a vaccine in three formulations for clinical use. The three vaccine formulations included (1) purified outer membrane proteins (OMPs) and L8-5 dLOS adsorbed to aluminum hydroxide; (2) purified OMPs and L8-5 dLOS incorporated into liposomes; and (3) purified OMPs and L7 dLOS incorporated into proteoliposomes. The vaccines were compared for immunogenicity and safety in a phase 1clinical study. Ten adult volunteers were vaccinated with each of the three vaccine formulations. Two 50 μg doses were given six weeks apart, and serum samples were obtained at 0, 2, 6, 8 and 14 weeks. Volunteers were evaluated for reactogenicity 30 min after vaccination and at days 1, 2, and 14 after each vaccination, and laboratory safety tests were done at 0, 2 and 6 weeks. Overall, the vaccines were well tolerated. Bactericidal assays against a homologous strain showed a four-fold or greater increase in titer in 6 of 7 volunteers in group one, 9 of 10 volunteers in group two, and 5 of 10 volunteers in group three. A quantitative enzyme linked immunosorbant assay showed increases in antibody against both OMPs and LOS antigens. The liposome formulation appeared to be particularly effective in presenting the dLOS as an antigen.
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titlePhase I study of a Neisseria meningitidis liposomal vaccine containing purified outer membrane proteins and detoxified lipooligosaccharide
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abstractHighlights ► Immunogenicity of outer membrane proteins not enhanced by combining with liposomes. ► Liposomes were an effective formulation for the presentation of lipooligosaccharides. ► Truncated L8-5 LOS induced antibodies bactericidal for strains with full length LOS. ► The strongest bactericidal antibody response was induced by the L8-5 LOS. Purified outer membrane proteins and purified deacylated lipooligosaccharide (dLOS) were formulated for use as a vaccine in three formulations for clinical use. The three vaccine formulations included (1) purified outer membrane proteins (OMPs) and L8-5 dLOS adsorbed to aluminum hydroxide; (2) purified OMPs and L8-5 dLOS incorporated into liposomes; and (3) purified OMPs and L7 dLOS incorporated into proteoliposomes. The vaccines were compared for immunogenicity and safety in a phase 1clinical study. Ten adult volunteers were vaccinated with each of the three vaccine formulations. Two 50 μg doses were given six weeks apart, and serum samples were obtained at 0, 2, 6, 8 and 14 weeks. Volunteers were evaluated for reactogenicity 30 min after vaccination and at days 1, 2, and 14 after each vaccination, and laboratory safety tests were done at 0, 2 and 6 weeks. Overall, the vaccines were well tolerated. Bactericidal assays against a homologous strain showed a four-fold or greater increase in titer in 6 of 7 volunteers in group one, 9 of 10 volunteers in group two, and 5 of 10 volunteers in group three. A quantitative enzyme linked immunosorbant assay showed increases in antibody against both OMPs and LOS antigens. The liposome formulation appeared to be particularly effective in presenting the dLOS as an antigen.
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doi10.1016/j.vaccine.2011.11.084
issue4
pages712-721
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