- |||||||||| Trumenba (meningococcal B vaccine) / Pfizer, Bexsero (meningococcal group B vaccine) / GSK
Review, Journal: Meningococcal factor H-binding protein as immune evasion factor and vaccine antigen. (Pubmed Central) - May 12, 2021
The 3-D structure of fHbp alone, in combination with fH or in complex with bactericidal antibodies has been key to understanding the molecular details of the protein. In this article, we will review the biochemical and immunological properties of fHbp, and its key role in meningococcal pathogenesis, complement regulation and immune evasion.
- |||||||||| Trumenba (meningococcal B vaccine) / Pfizer, Bexsero (meningococcal group B vaccine) / GSK
Journal: High genomic-based predicted strain coverage among invasive meningococcal isolates when combining Bexsero and Trumenba vaccines. (Pubmed Central) - Apr 28, 2021
The estimated serogroup-specific coverage for Bexsero respectively Trumenba was: MenB; 67% and 90% (p < 0.05), MenW; 93% and 4% (p < 0.05), MenC; 87% and 30% (p < 0.05) and MenY; 1% and 96% (p < 0.05). With the combination of the two vaccines, the potential genomic-based strain coverage was 95%, indicating a possible additive effect of combining Bexsero and Trumenba, which, however, needs to be confirmed by analysis of phenotypic antigen expression.
- |||||||||| Trumenba (meningococcal B vaccine) / Pfizer, zolmitriptan intracutaneous microneedle system (C213) / Zosano, Bexsero (meningococcal group B vaccine) / GSK
Journal: Molecular characterization of invasive serogroup B Neisseria meningitidis isolates from Spain during 2015-2018: evolution of the vaccine antigen factor H binding protein (FHbp). (Pubmed Central) - Apr 24, 2021
With the combination of the two vaccines, the potential genomic-based strain coverage was 95%, indicating a possible additive effect of combining Bexsero and Trumenba, which, however, needs to be confirmed by analysis of phenotypic antigen expression. Due to invasive meningococcal strains temporal variability (eg prevalence of the cc213 increased from 3.6% in 2007 to 33% in 2018) affecting to the presence and distribution of the vaccine antigens, continuous detailed meningococcal surveillance and monitoring of the vaccine antigens is needed to determine the degree and durability of coverage provided by these protein vaccine.
- |||||||||| Trumenba (meningococcal B vaccine) / Pfizer, Nimenrix (MenACWY-TT) / Pfizer
Enrollment change: A Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of MenABCWY in Healthy Infants (clinicaltrials.gov) - Mar 3, 2021
P2b, N=1325, Recruiting,
Due to invasive meningococcal strains temporal variability (eg prevalence of the cc213 increased from 3.6% in 2007 to 33% in 2018) affecting to the presence and distribution of the vaccine antigens, continuous detailed meningococcal surveillance and monitoring of the vaccine antigens is needed to determine the degree and durability of coverage provided by these protein vaccine. N=550 --> 1325
- |||||||||| Trumenba (meningococcal B vaccine) / Pfizer
Journal: Control Strategy Approach for a Well-Characterized Vaccine Drug Product. (Pubmed Central) - Jan 28, 2021
This was achieved by studying the impact of the approach on product quality attributes to define process parameter and in-process controls. This approach is further explained through Trumenba® case studies, highlighting specific quality attributes and the associated controls implemented, and provides a holistic view of controls employed for both drug substance and drug product.
- |||||||||| Journal: In Brief: New meningococcal serogroup B vaccination recommendations. (Pubmed Central) - Jan 26, 2021
This approach is further explained through Trumenba® case studies, highlighting specific quality attributes and the associated controls implemented, and provides a holistic view of controls employed for both drug substance and drug product. No abstract available
- |||||||||| Trumenba (meningococcal B vaccine) / Pfizer, Menactra (Meningococcal-groups A, C, Y and W-135 polysaccharide diphtheria toxoid conjugate vaccine) / Sanofi, Bexsero (meningococcal group B vaccine) / GSK
[VIRTUAL] Assessing Awareness of Meningitis B Vaccination in College Students () - Dec 26, 2020 - Abstract #ASHP2020ASHP_3060;
Research suggests confusion remains between the two types of meningitis vaccines. Educational initiatives are needed to close the knowledge gap for college students and pharmacy faculty to improve awareness of MenB and increase vaccination rates among students.
- |||||||||| Trumenba (meningococcal B vaccine) / Pfizer, Bexsero (meningococcal group B vaccine) / GSK
Clinical, Review, Journal: A review of the immunogenicity, safety and current recommendations for the meningococcal serogroup B vaccine, MenB-FHbp. (Pubmed Central) - Dec 18, 2020
Educational initiatives are needed to close the knowledge gap for college students and pharmacy faculty to improve awareness of MenB and increase vaccination rates among students. Because vaccination provides the most effective protection against IMD, pharmacists are in an excellent position to offer evidence-based vaccine information, as well as to encourage and provide meningococcal immunizations to adolescents and young adults.
- |||||||||| Trumenba (meningococcal B vaccine) / Pfizer
Clinical, Journal, Adverse events: Safety Surveillance of Bivalent Meningococcal Group B Vaccine, Vaccine Adverse Event Reporting System, 2014-2018. (Pubmed Central) - Dec 17, 2020
In October 2014, MenB-FHbp (Trumenba, Pfizer) became the first meningococcal group B vaccine licensed in the United States...The AEs most commonly or disproportionately reported following MenB-FHbp were consistent with those identified in clinical trials as described in the US package insert. We did not identify any new safety issues.
- |||||||||| Trumenba (meningococcal B vaccine) / Pfizer
Review, Journal: Vaccines against Meningococcal Diseases. (Pubmed Central) - Oct 8, 2020
Further research into changing epidemiology is needed. Ongoing efforts are being made to develop next-generation, pentavalent vaccines including a MenACWYX conjugate vaccine and a MenACWY conjugate vaccine combined with MenB, which are expected to contribute to the global control of meningitis.
- |||||||||| Trumenba (meningococcal B vaccine) / Pfizer
Journal: Health Technology Assessment of meningococcal B vaccine (Trumenba) in adolescent in Italy (Pubmed Central) - Jul 24, 2020
Our results add to the sparse published molecular data of N. meningitidis in the military units in Vietnam, highlight their diversity, distinct genetic features and antibiotic resistance pattern, and emphasize the need for further studies on the molecular characteristics of N. meningitidis in Vietnam. No abstract available
- |||||||||| Trumenba (meningococcal B vaccine) / Pfizer
Trumenba (Twitter) - Apr 7, 2020
- |||||||||| Trumenba (meningococcal B vaccine) / Pfizer
Journal: Summary of the NACI Statement on the Use of Bivalent Factor H Binding Protein Meningococcal Serogroup B (MenB-fHBP) Vaccine for the Prevention of Meningococcal B Disease. (Pubmed Central) - Mar 14, 2020
TrumenbaTM, a bivalent, factor-H binding protein meningococcal serogroup B (MenB-fHBP) vaccine was authorized for use in Canada in October 2017 for the prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroup B in individuals 10-25 years of age...In addition to providing guidance to public health decision-makers (i.e. provinces/territories making decisions for publicly-funded immunization programs), these NACI recommendations provide information to individuals, vaccine providers and organizations about vaccines that may not currently be included in publicly funded immunization programs. NACI continues to recommend against the use of the serogroup B vaccines in routine universal immunization programs in Canada at this time.
- |||||||||| Trumenba (meningococcal B vaccine) / Pfizer
Journal: Cost calculator for mass vaccination response to a US college campus outbreak of serogroup B meningococcal disease. (Pubmed Central) - Mar 2, 2020
Based on the actual Providence College population partially or fully vaccinated with MenB-FHbp (Trumenba®, Bivalent rLP2086) (3-dose schedule), the calculator estimated aggregate direct costs of $1,350,963 over 18 months post-outbreak for 4,418 individuals...In both cases, the majority of costs were for medical supplies (88%-89%) and contract services (7%-9%). This calculator can help to plan a mass vaccination campaign for MenB outbreak control, and underscores the need to vaccinate pre-emptively against diverse disease-causing strains before an outbreak occurs.
- |||||||||| Journal: Parental awareness of Meningococcal B vaccines and willingness to vaccinate their teens. (Pubmed Central) - Feb 22, 2020
This calculator can help to plan a mass vaccination campaign for MenB outbreak control, and underscores the need to vaccinate pre-emptively against diverse disease-causing strains before an outbreak occurs. Awareness of MenB vaccine is lacking among parents of teens but is an important predictor of willingness to vaccinate with the newly licensed MenB vaccines.
- |||||||||| Trumenba (meningococcal B vaccine) / Pfizer, Bexsero (meningococcal group B vaccine) / GSK
Journal: Structural basis for cooperativity of human monoclonal antibodies to meningococcal factor H-binding protein. (Pubmed Central) - Jan 13, 2020
The 3D electron microscopy structures of the human mAb-fHbp-mAb cooperative complexes indicate that the angle formed between the antigen binding fragments (fAbs) assume regular angle and that fHbp is able to bind simultaneously and stably the cooperative mAbs pairs and human factor H (fH) in vitro. These findings shed light on molecular basis of the antibody-based mechanism of protection driven by simultaneous recognition of the different epitopes of the fHbp and underline that cooperativity is crucial in vaccine efficacy.
- |||||||||| Trumenba (meningococcal B vaccine) / Pfizer, Bexsero (meningococcal group B vaccine (rDNA, component, adsorbed)) / GSK
Journal: Meningococcal Group B Vaccine For The Prevention Of Invasive Meningococcal Disease Caused By Neisseria meningitidis Serogroup B. (Pubmed Central) - Oct 22, 2019
Additional data on real-life effectiveness, long-term immunity, and eventual herd effects, including estimates on vaccine impact for cost-effectiveness assessment are further needed. Given the predominance of MenB in Europe and other parts of the world, these new vaccines are crucial for the prevention and public health control of the disease, and should be considered.
- |||||||||| Trumenba (meningococcal B vaccine) / Pfizer, Bexsero (meningococcal group B vaccine (rDNA, component, adsorbed)) / GSK
Journal: Structural basis for cooperativity of human monoclonal antibodies to meningococcal factor H-binding protein. (Pubmed Central) - Jul 3, 2019
The 3D electron microscopy structures of the human mAb-fHbp-mAb cooperative complexes indicate that the angle formed between the antigen binding fragments (fAbs) assume regular angle and that fHbp is able to bind simultaneously and stably the cooperative mAbs pairs and human factor H (fH) in vitro. These findings shed light on molecular basis of the antibody-based mechanism of protection driven by simultaneous recognition of the different epitopes of the fHbp and underline that cooperativity is crucial in vaccine efficacy.
- |||||||||| Trumenba (meningococcal B vaccine) / Pfizer
Journal: Introduction of a second MenB vaccine into Europe - needs and opportunities for public health. (Pubmed Central) - May 17, 2019
...The European Medicines Agency approved the use of MenB-fHbp (Trumenba®; Pfizer Ltd, Sandwich, UK) in individuals ≥10 years of age for the prevention of MenB IMD in May 2017...Expert opinion: MenB is by far the most prevalent meningococcal serogroup in Europe, and its epidemiology is not currently addressed by European immunization recommendations. New strategies to prevent MenB IMD in Europe will continue to develop with the growing use of vaccines to prevent MenB disease, with increasing support through national immunization programs.
- |||||||||| Trumenba (meningococcal B vaccine) / Pfizer
Clinical, Journal: A new meningococcal B vaccine for adolescents and adults: characteristics and methods of use. (Pubmed Central) - May 11, 2019
For this reason, the Trumenba vaccine should be used routinely with the 2-dose schedule (0-6 months). The 3-doses use could be considered in particular situations, like an occurring epidemic or particular individual risk factors such as asplenia or complement deficit, but is not needed for underlying conditions like diabetes or heart diseases.
- |||||||||| Trumenba (meningococcal B vaccine) / Pfizer
Clinical, Journal: MenB-FHbp Meningococcal Group B Vaccine (Trumenba®): A Review in Active Immunization in Individuals Aged ≥ 10 Years. (Pubmed Central) - Apr 5, 2019
MenB-FHbp vaccine appears to be moderately reactogenic but, overall, is generally well tolerated, with most adverse reactions being mild to moderate in severity. Although post-marketing, population-based data will be required to establish the true effectiveness of the vaccine, currently available data indicate that MenB-FHbp, in a two-dose or three-dose series, is likely to provide broad protection against MenB strains circulating in Europe.
- |||||||||| Trumenba (meningococcal B vaccine) / Pfizer
Trial completion date: Immunogenicity, Safety and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recominant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Toddlers. (clinicaltrials.gov) - Jan 9, 2019
P2, N=398, Active, not recruiting,
Although post-marketing, population-based data will be required to establish the true effectiveness of the vaccine, currently available data indicate that MenB-FHbp, in a two-dose or three-dose series, is likely to provide broad protection against MenB strains circulating in Europe. Trial completion date: Mar 2021 --> Mar 2020
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