scholarly journals Combined Administration of Meningococcal Serogroup B Outer Membrane Vesicle Vaccine and Conjugated Serogroup C Vaccine Indicated for Prevention of Meningococcal Disease Is Safe and Immunogenic

2005 ◽  
Vol 12 (5) ◽  
pp. 599-605 ◽  
Author(s):  
Ingeborg S. Aaberge ◽  
Philipp Oster ◽  
Oddveig S. Helland ◽  
Anne-Cathrine Kristoffersen ◽  
Ellen Ypma ◽  
...  
Keyword(s):  
Immune Responses ◽  
Outer Membrane ◽  
Meningococcal Disease ◽  
Membrane Vesicle ◽  
Enzyme Linked Immunosorbent Assay ◽  
Outer Membrane Vesicle ◽  
Active Components ◽  
Serious Adverse Events ◽  
Group B ◽  
Combined Vaccine

ABSTRACT MenBvac and Menjugate are safe and efficacious vaccines. The purpose of this study was to evaluate safety and immunogenicity of the combination (MenB/C) of the lyophilized active components of the conjugated group C vaccine Menjugate when reconstituted with the full liquid group B outer membrane vesicle vaccine MenBvac compared to MenBvac and Menjugate given separately. At 6-week intervals, healthy adults were given one dose of MenB/C followed by two doses of MenBvac (MenB/C group), three doses of MenBvac (MenB group), or one dose of Menjugate and two doses of placebo (MenC group). Injection site reactions were frequent in all groups. However, most reactions were short lasting and mild or moderate in intensity, and the vaccines were found to be well tolerated, with no vaccine-related serious adverse events. MenB/C was immunogenic with regard to both serogroup B and C meningococci. Both the serum bactericidal assay and the enzyme-linked immunosorbent assay analyses showed that the immune responses of the combination vaccine were similar to the immune responses of its separate components MenBvac and Menjugate for both serogroup B and C. In conclusion, the combined MenB/C vaccine is safe and immunogenic. The two vaccines do not interact negatively with each other and can easily be administered in the same syringe. The induced immune responses suggest that the combined vaccine is likely to confer protection against systemic group B disease caused by the vaccine strain as well as against group C meningococcal disease.

Effect of outer membrane vesicle vaccine against group B meningococcal disease in Norway

The Lancet ◽  
1991 ◽  
Vol 338 (8775) ◽  
pp. 1093-1096 ◽  
Author(s):  
G Bjune ◽  
E.A Høiby ◽  
J.K Grønnesby ◽  
Ø Arnesen ◽  
J.H Fredriksen ◽  
...  
Keyword(s):  
Outer Membrane ◽  
Meningococcal Disease ◽  
Membrane Vesicle ◽  
Outer Membrane Vesicle ◽  
Group B

scholarly journals Persisting Immune Responses Indicating Long-Term Protection after Booster Dose with Meningococcal Group B Outer Membrane Vesicle Vaccine

2006 ◽  
Vol 13 (7) ◽  
pp. 790-796 ◽  
Author(s):  
Berit Feiring ◽  
Jan Fuglesang ◽  
Philipp Oster ◽  
Lisbeth M. Næss ◽  
Oddveig S. Helland ◽  
...  
Keyword(s):  
Outer Membrane ◽  
Vaccine Strain ◽  
Booster Dose ◽  
Membrane Vesicle ◽  
Enzyme Linked Immunosorbent Assay ◽  
Double Blind Study ◽  
Outer Membrane Vesicle ◽  
Serious Adverse Events ◽  
Vaccine Type ◽  
Fourth Dose

ABSTRACT MenBvac is an outer membrane vesicle vaccine against systemic meningococcal disease caused by serogroup B Neisseria meningitidis. In this placebo-controlled double-blind study including 374 healthy adolescents, the safety and immunogenicity of a schedule of three primary doses 6 weeks apart followed by a fourth dose a year later were evaluated. Antibody responses to the vaccine strain and heterologous strains (non-vaccine-type strains) and the persistence of these antibodies were measured by the serum bactericidal assay (SBA) and enzyme-linked immunosorbent assay up to 1 year after the last dose. The proportion of subjects with SBA titers of ≥4 against the vaccine strain increased from 3% prevaccination to 65% after the third dose. Ten months later, this proportion had declined to 28%. The fourth dose induced a booster response demonstrated by 93% of subjects achieving a titer of ≥4. One year after the booster dose, 64% still showed SBA titers of ≥4. Cross-reacting antibodies were induced against all heterologous strains tested, although the magnitude of SBA titers differed widely between the different strains. All four doses of MenBvac were safe. Both MenBvac and the placebo had reactogenicity profiles of mild to moderate local and systemic reactions. Pain, the most common reaction, was reported with similar frequencies in both groups. No serious adverse events occurred in the MenBvac group. This study confirmed the good immunogenicity of the primary course of MenBvac and demonstrated prolonged persistence and increased cross-reactivity of functional antibodies elicited by a booster dose.

scholarly journals Immunogenicity and Safety of a Combination of Two Serogroup B Meningococcal Outer Membrane Vesicle Vaccines

2007 ◽  
Vol 14 (9) ◽  
pp. 1062-1069 ◽  
Author(s):  
Synne Sandbu ◽  
Berit Feiring ◽  
Philipp Oster ◽  
Oddveig S. Helland ◽  
Hilde S. W. Bakke ◽  
...  
Keyword(s):  
Immune Responses ◽  
Meningococcal Disease ◽  
Booster Dose ◽  
Membrane Vesicle ◽  
Serious Adverse Events ◽  
Systemic Reactions ◽  
Monovalent Vaccine ◽  
Considerable Impact ◽  
Combined Vaccine ◽  
Meningococcal Strain

ABSTRACT MenBvac and MeNZB are safe and efficacious vaccines against serogroup B meningococcal disease. MenBvac is prepared from a B:15:P1.7,16 meningococcal strain (strain 44/76), and MeNZB is prepared from a B:4:P1.7-2,4 strain (strain NZ98/254). At 6-week intervals, healthy adults received three doses of MenBvac (25 μg), MeNZB (25 μg), or the MenBvac and MeNZB (doses of 12.5 μg of each vaccine) vaccines combined, followed by a booster 1 year later. Two-thirds of the subjects who received a monovalent vaccine in the primary schedule received the other monovalent vaccine as a booster dose. The immune responses to the combined vaccine were of the same magnitude as the homologous responses to each individual vaccine observed. At 6 weeks after the third dose, 77% and 87% of the subjects in the combined vaccine group achieved serum bactericidal titers of ≥4 against strains 44/76 and NZ98/254, respectively, and 97% and 93% of the subjects achieved a fourfold or greater increase in opsonophagocytic activity against strains 44/76 and NZ98/254, respectively. For both strains, a trend of higher responses after the booster dose was observed in all groups receiving at least one dose of the respective strain-specific vaccine. Local and systemic reactions were common in all vaccine groups. Most reactions were mild or moderate in intensity, and there were no vaccine-related serious adverse events. The safety profile of the combined vaccine was not different from those of the separate monovalent vaccines. In conclusion, use of either of the single vaccines or the combination of MenBvac and MeNZB may have a considerable impact on the serogroup B meningococcal disease situation in many countries.

scholarly journals Comparison and Correlation of Neisseria meningitidis Serogroup B Immunologic Assay Results and Human Antibody Responses following Three Doses of the Norwegian Meningococcal Outer Membrane Vesicle Vaccine MenBvac

2006 ◽  
Vol 74 (8) ◽  
pp. 4557-4565 ◽  
Author(s):  
Jamie Findlow ◽  
Stephen Taylor ◽  
Audun Aase ◽  
Rachel Horton ◽  
Robert Heyderman ◽  
...  
Keyword(s):  
Neisseria Meningitidis ◽  
Outer Membrane ◽  
Membrane Vesicle ◽  
Enzyme Linked Immunosorbent Assay ◽  
Human Antibody ◽  
Outer Membrane Vesicle ◽  
Phagocytic Cells ◽  
Bactericidal Antibody ◽  
Antibody Elisa ◽  
Immunologic Assays

ABSTRACT The prediction of efficacy of Neisseria meningitidis serogroup B (MenB) vaccines is currently hindered due to the lack of an appropriate correlate of protection. For outer membrane vesicle (OMV) vaccines, immunogenicity has primarily been determined by the serum bactericidal antibody (SBA) assay and OMV enzyme-linked immunosorbent assay (ELISA). However, the opsonophagocytic assay (OPA), surface labeling assay, whole blood assay (WBA), and salivary antibody ELISA have been developed although correlation with protection is presently undetermined. Therefore, the aim of the study was to investigate further the usefulness of, and relationships between, MenB immunologic assays. A phase II trial of the OMV vaccine, MenBvac, with proven efficacy was initiated to compare immunologic assays incorporating the vaccine and six heterologous strains. Correlations were achieved between the SBA assay, OMV ELISA, and OPA using human polymorphonuclear leukocytes and human complement but not between an OPA using HL60 phagocytic cells and baby rabbit complement. Correlations between the surface labeling assay, the SBA assay, and the OMV ELISA were promising, although target strain dependent. Correlations between the salivary antibody ELISA and other assays were poor. Correlations to the WBA were prevented since many samples had results greater than the range of the assay. The study confirmed the immunogenicity and benefit of a third dose of MenBvac against the homologous vaccine strain using a variety of immunologic assays. These results emphasize the need for standardized methodologies that would allow a more robust comparison of assays between laboratories and promote their further evaluation as correlates of protection against MenB disease.

scholarly journals Antibody Avidity and Immunoglobulin G Isotype Distribution following Immunization with a Monovalent Meningococcal B Outer Membrane Vesicle Vaccine

2002 ◽  
Vol 70 (2) ◽  
pp. 584-590 ◽  
Author(s):  
C. L. Vermont ◽  
H. H. van Dijken ◽  
C. J. P. van Limpt ◽  
R. de Groot ◽  
L. van Alphen ◽  
...  
Keyword(s):  
Outer Membrane ◽  
Immunoglobulin G ◽  
Protective Immunity ◽  
Membrane Vesicle ◽  
Booster Vaccination ◽  
Phase Iii ◽  
Enzyme Linked Immunosorbent Assay ◽  
Outer Membrane Vesicle ◽  
Before And After ◽  
Avidity Maturation

ABSTRACT The avidity maturation and immunoglobulin G (IgG) isotype distribution of antibodies after vaccination with a meningococcal B outer membrane vesicle (OMV) vaccine were evaluated as indicators of protective immunity. Pre- and postvaccination sera from 134 healthy toddlers (ages, 2 to 3 years) immunized with a monovalent meningococcal B OMV (serosubtype P1.7-2,4) vaccine adsorbed with AlPO4 or Al(OH)3 were analyzed by enzyme-linked immunosorbent assay (ELISA) methods. The children were vaccinated three times with intervals of 3 to 6 weeks between vaccinations or twice with an interval of 6 to 10 weeks between vaccinations. A booster was given after 20 to 40 weeks. The avidity index (AI) of antibodies increased significantly during the primary series of vaccinations and after the booster was given. No differences in AIs were found when the results obtained with the two vaccination schedules or with the two adjuvants were compared. After vaccination, IgG1 was the predominant IgG isotype, followed by IgG3. No IgG2 or IgG4 was detected. There was a strong correlation between serum bactericidal activity (SBA) and ELISA titers (r = 0.85 [P < 0.0001] for total IgG, r = 0.83 for IgG1 [P < 0.0001], r = 0.82 for IgG3 [P < 0.0001], and r = 0.84 [P < 0.0001] for the avidity titer). When two subgroups with similar anti-OMV IgG levels were compared before and after the booster vaccination, the higher AI after the booster vaccination was associated with significantly increased SBA. We concluded that avidity maturation occurs after vaccination with a monovalent meningococcal B OMV vaccine, especially after boosting, as indicated by a significant increase in the AI. Vaccination with the monovalent OMV vaccine induced mainly IgG1 and IgG3 isotypes, which are considered to be most important for protection against meningococcal disease. An increase in the AI of antibodies is associated with increased SBA, independent of the level of specific IgG and the IgG isotype distribution. Measuring the AI and IgG isotype distribution of antibodies after vaccination can be a supplementary method for predicting protective immunity for evaluation in future phase III trials with meningococcal serogroup B vaccines.

Safety and Immunogenicity Testing of an Intranasal Group B Meningococcal Native Outer Membrane Vesicle Vaccine in Healthy Volunteers

1998 ◽  
Author(s):  
Joseph J. Drabick ◽  
Brenda L. Brandt ◽  
Elizabeth E. Moran ◽  
Nancy B. Saunders ◽  
David R. Shoemaker
Keyword(s):  
Healthy Volunteers ◽  
Outer Membrane ◽  
Membrane Vesicle ◽  
Outer Membrane Vesicle ◽  
Group B
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