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

Vaccine

Volumn 30, Issue 4, 2012, Pages 712-721

  Zollinger, Wendell D ^a   Babcock, Janiine G ^a   Moran, Elizabeth E ^a   Brandt, Brenda L ^a   Matyas, Gary R ^a   Wassef, Nabila M ^a   Alving, Carl R ^a  

^a WALTER REED ARMY INSTITUTE OF RESEARCH   (United States)

Author keywords

Human; Lipooligosaccharide; Liposome; Neisseria meningitidis; Vaccine

Indexed keywords

ALUMINUM HYDROXIDE; BACTERIAL VACCINE; BACTERIUM ANTIBODY; LIPOOLIGOSACCHARIDE; LIPOSOME; NEISSERIA MENINGITIDIS LIPOSOMAL VACCINE; OUTER MEMBRANE PROTEIN; PROTEOLIPOSOME; UNCLASSIFIED DRUG;

ADULT; ANTIBODY RESPONSE; ANTIBODY TITER; ARTICLE; BACTERIAL STRAIN; BACTERICIDAL ACTIVITY; BLOOD SAMPLING; DEACYLATION; DRUG FORMULATION; DRUG SAFETY; DRUG TOLERABILITY; ENZYME LINKED IMMUNOSORBENT ASSAY; ERYTHEMA; FATIGUE; FEMALE; FEVER; HEADACHE; HUMAN; HUMAN CELL; HUMAN EXPERIMENT; IMMUNOGENICITY; IMMUNOREACTIVITY; INJECTION SITE PAIN; MALE; NEISSERIA MENINGITIDIS; NONHUMAN; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEIN PURIFICATION; SKIN INDURATION; SKIN REDNESS; SWELLING; VACCINATION;

ADJUVANTS, IMMUNOLOGIC; ADOLESCENT; ADULT; ALUMINUM HYDROXIDE; BACTERIAL OUTER MEMBRANE PROTEINS; BLOOD BACTERICIDAL ACTIVITY; FEMALE; HUMANS; LIPOPOLYSACCHARIDES; LIPOSOMES; MALE; MENINGOCOCCAL VACCINES; MIDDLE AGED; NEISSERIA MENINGITIDIS; YOUNG ADULT;

EID: 84855354748     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2011.11.084     Document Type: Article

References (43)

1. Giuliani M.M., Adu-Bobie J., Comanducci M., Aricò B., Savino S., Santini L., et al. A universal vaccine for serogroup B meningococcus. Proc Natl Acad Sci USA 2006, 103:10834-10839.
2. Jiang H.Q., Hoiseth S.K., Harris S.L., McNeil L.K., Zhu D., Tan C., et al. Broad vaccine coverage predicted for a bivalent recombinant factor H binding protein based vaccine to prevent serogroup B meningococcal disease. Vaccine 2010, 28:6086-6093.
3. Findlow J., Borrow R., Snape M.D., Dawson T., Holland A., John T.M., et al. Multicenter, open-label, randomized Phase II controlled trial of an investigational recombinant meningococcal serogroup B vaccine with and without outer membrane vesicles, administered in infancy. Clin Infect Dis 2010, 51:1127-1137.
4. Sierra G.V.G., Campa H.C., Varacel N.M., Garcia I.L., Izquierdo P.L., Sotolongo P.F., et al. Vaccine against group B Neisseria meningitidis: protection trial and mass vaccination results in Cuba. NIPH Ann 1991, 14:195-210.
5. de Moraes J.C., Perkins B.A., Camargo M.C.C., Hidalgo N.T.R., Barbosa H.A., Sacchi C.T., et al. Protective efficacy of a serogroup B meningococcal vaccine in Sao Paulo, Brazil. Lancet 1992, 340:1074-1078.
6. Bjune G., Høiby E.A., Grønnesby J.K., Arnesen Ø., Holst J., Fredriksen J.H., et al. Effect of outer membrane vesicle vaccine against serogroup B meningococcal disease in Norway. Lancet 1991, 338:1093-1096.
7. Oster P., Lennon D., O'Hallahan J., Mulholland K., Reid S., Martin D. MeNZB™: a safe and highly immunogenic tailor-made vaccine against the New Zealand Neisseria meningitidis serogroup B disease epidemic strain. Vaccine 2005, 23:2191-2196.
8. Claassen I., Meylis J., van der Ley P., Peeters C., Brons H., Robert J., et al. Production, characterization and control of a Neisseria meningitidis hexavalent class 1 outer membrane protein containing vesicle vaccine. Vaccine 1996, 14:1001-1008.
9. van den Dobbelsteen G.P., van Dijken H.H., Pillai S., van Alphen L. Immunogenicity of a combination vaccine containing pneumococcal conjugates and meningococcal PorA OMVs. Vaccine 2007, 25:2491-2496. [Epub 20.09.06].
10. Schmiel D.H., Moran E.E., Keiser P., Brandt B., Zollinger W.D. Importance of antibodies to lipopolysaccharide in natural and vaccine-induced serum bactericidal activity against Neisseria meningitidis group B. Infection and Immun. Infect Immun 2011, 79:4146-4156. [Epub 18.07.11].
11. Drabick J.J., Brandt B.L., Moran E.E., Saunders N.B., Shoemaker D.R., Zollinger W.D. Safety and immunogenicity testing of an intranasal group B meningococcal native outer membrane vesicle vaccine in healthy volunteers. Vaccine 1999, 18:160-172.
12. Zollinger W.D., Donets M.A., Schmiel D.H., Pinto V.B., Labrie J., Moran E.E., et al. Design and evaluation in animals of a broadly protective meningococcal group B native outer membrane vesicle vaccine. Vaccine 2010, 28:5057-5067.
13. Keiser P.B., Biggs-Cicatelli S., Moran E.E., Schmiel D.H., Pinto V.B., Burden R.E., et al. A phase 1 study of a meningococcal native outer membrane vesicle vaccine made from a group B strain with deleted lpxL1 and synX, over-expressed factor H binding protein, two PorAs and stabilized OpcA expression. Vaccine 2011, 29:1413-1420.
14. Katial R.K., Brandt B.L., Moran E.E., Agnello V., Zollinger W.D. Group B intranasal meningococcal native outer membrane vesicle vaccine: immunogenicity and safety testing. Infect Immun 2002, 70:702-707.
15. Keiser P.B., Gibbs B.T., Coster T.S., Moran E.E., Stoddard M.B., Labrie J.E., et al. A phase 1 study of a group B meningococcal native outer membrane vesicle vaccine made from a strain with deleted lpxL2 and synX and stable expression of opcA. Vaccine 2010, 28:6970-6976.
16. Boslego J., Garcia J., Cruz C., Zollinger W., Brandt B., Ruiz S., et al. Efficacy, safety, and immunogenicity of a meningococcal group B (15:P1.3) outer membrane protein vaccine in Iquique, Chile. Vaccine 1995, 13:821-829.
17. Kogan G., Uhrín D., Brisson J.R., Jennings H.J. Structural basis of the Neisseria meningitidis immunotypes including the L4 and L7 immunotypes. Carbohydr Res 1997, 298:191-199.
18. Moran E.E., Brandt B.L., Zollinger W.D. Expression of the L8 lipopolysaccharide determinant increases the sensitivity of Neisseria meningitidis to serum bactericidal activity. Infect Immun 1994, 62:5290-5295.
19. Zollinger WD, Boslego J, Moran E, Brandt B, Collins H, Mandrell R, et al. Process for the preparation of detoxified polysaccharide-outer membrane protein complexes, and their use as antibacterial vaccines. U.S. Patent No. 4,707,543; November 17, 1987.
20. Westphal O., Luderitz O., Bister F. Uber die Extraktion von bakterien mit Phenol/Wasser. Z Naturforsch 1952, 7b:148-155.
21. Wassef N.M., Alving C.R., Richards R.L. Liposomes as carriers for vaccines. Immunomethods 1994, 4:217-222.
22. Zollinger W.D., Moran E.E., Schmiel D.H. Characterization of an antibody depletion assay for analysis of bactericidal antibody specificity. Clin Vaccine Immunol 2009, 16:1789-1795.
23. Zollinger W.D., Boslego J.W. A general approach to standardization of the solid-phase radioimmunoassay for quantitation of class-specific antibodies. J Immunol Methods 1981, 46:129-140.
24. Saunders N.B., Shoemaker D.R., Brandt B.L., Moran E.E., Larsen T., Zollinger W.D. Immunogenicity of intranasally administered meningococcal native outer membrane vesicles in mice. Infect Immun 1999, 67:113-119.
25. Mandrell R.E., Griffiss J.M., Lipooligosaccharides Macher B.A. (LOS) of Neisseria gonorrhoeae and Neisseria meningitidis have components that are immunochemically similar to precursors of human blood group antigens. Carbohydrate sequence specificity of the mouse monoclonal antibodies that recognize crossreacting antigens on LOS and human erythrocytes. J Exp Med 1988, 168:107-126.
26. Lowry O.H., Rosebrough N.J., Farr A.L., Randall R.J. Protein measurement with the Folin phenol reagent. J Biol Chem 1951, 193:265-275.
27. Karkhanis Y.D., Zeltner J.Y., Jackson J.J., Carlo D.J. A new and improved microassay to determine 2-keto-3-deoxyoctonate in lipopolysaccharide of Gram-negative bacteria. Anal Biochem 1978, 85:595-601.
28. Laemmli U.K. Cleavage of structural proteins during the assembly of the head of bacteriophage T4. Nature 1970, 227:680-685.
29. Tsai C.M., Frasch C.E. A sensitive silver stain for detecting lipopolysaccharides in polyacrylamide gels. Anal Biochem 1982, 119:115-119.
30. Alving C.R. Liposomes as carriers of antigens and adjuvants. J Immunol Meth 1991, 140:1-13.
31. Fries L.F., Gordon D.M., Richards R.L., Egan J.E., Hollingdale M.R., Gross M., et al. Liposomal malaria vaccine in humans: a safe and potent adjuvant strategy. Proc Natl Acad Sci USA 1992, 89:358-362.
32. Steers N.J., Peachman K.K., McClain S., Alving C.R., Rao M. Liposome-encapsulated HIV-1 Gag p24 containing lipid A induces effector CD4+ T-cells memory CD8+ T-cells, and pro-inflammatory cytokines. Vaccine 2009, 27:6939-6949.
33. Heppner D.C., Gordon D.M., Wellde B., Leitner W., Krzych U., Schneider I., et al. Safety, immunogenicity, and efficacy of Plasmodium falciparum repeatless circumsporozoite protein vaccine encapsulated in liposomes. J Infect Dis 1996, 174:361-366.
34. Pavliak V, Fortuna-Nevin M, Monteiro M, Mason K, Zhu D. Neisseria meningitidis LOS conjugate vaccine against meningococcal disease. In: Abstr 14th international pathogenic neisseria conference. Milwaukee, WI; 2004. p. 8 [Abstr].
35. Cox A.D., Zou W., Gidney M.A., Lacelle S., Plested J.S., Makepeace K., et al. Candidacy of LPS-based glycoconjugates to prevent invasive meningococcal disease: developmental chemistry and investigation of immunological responses following immunization of mice and rabbits. Vaccine 2005, 23:5045-5054.
36. Petrov A.B., Semenov F.B., Vartanyan Y.P., Zakirov M.M., Torchilin V.P., Trubetskoy V.S., et al. Toxicity and immunogenicity of Neisseria meningitidis lipopolysaccharide incorporated into liposomes. Infect Immun 1992, 60:3897-3903.
37. Orr N., Robin G., Cohen D., Arnon R., Lowell G.H. Immunogenicity and efficacy of oral or intranasal Shigella flexneri 2a and Shigella sonnei proteosome-lipopolysaccharide vaccines in animal models. Infect Immun 1993, 61:2390-2395.
38. Ruegg C.L., Jaffe R.I., Köster B., Sadoff J.C., Zollinger W.D., Lowell G.H., et al. Preparation of proteosome-based vaccines. Correlation of immunogenicity with physical characteristics. J Immunol Methods 1990, 135:101-109.
39. Idänpään-Heikkilä I., Muttilainen S., Wahlström E., Saarinen L., Leinonen M., Sarvas M., et al. The antibody response to a prototype liposome vaccine containing Neisseria meningitidis outer membrane protein P1 produced in Bacillus subtilis. Vaccine 1995, 13:1501-1508.
40. Christodoulides M., Brooks J.L., Rattue E., Heckels J.E. Immunization with recombinant class 1 outer-membrane protein from Neisseria meningitidis: influence of liposomes and adjuvants on antibody avidity, recognition of native protein and the induction of a bactericidal immune response against meningococci. Microbiology 1998, 144:3027-3037.
41. Humphries H.E., Williams J.N., Blackstone R., Jolley K.A., Yuen H.M., Christodoulides M., et al. Multivalent liposome-based vaccines containing different serosubtypes of PorA protein induce cross-protective bactericidal immune responses against Neisseria meningitidis. Vaccine 2006, 24:36-44. [Epub 02.08.05].
42. Jolley K.A., Appleby L., Wright J.C., Christodoulides M., Heckels J.E. Immunization with recombinant Opc outer membrane protein from Neisseria meningitidis: influence of sequence variation and levels of expression on the bactericidal immune response against meningococci. Infect Immun 2001, 69:3809-3816.
43. Mandrell R.E., Zollinger W.D. Use of a zwitterionic detergent for the restoration of the antibody-binding capacity of electroblotted meningococcal outer membrane proteins. J Immunol Methods 1984, 67:1-11.