Trumenba (meningococcal B vaccine) / Pfizer - LARVOL DELTA

Emergence of Neisseria meningitidis Causing Both Urogenital Infection and Invasive Meningococcal Disease in China. (PubMed, Int J Infect Dis) - "These three urethritis isolates were also predicted to be covered by Trumenba. Nm strains causing urogenital infections have emerged in China."

Journal • Infectious Disease • Meningococcal Infections • Urology

Interlaboratory study to assess precision and reproducibility of the meningococcal antigen surface expression (MEASURE) assay to quantify factor H binding protein expression at the surface of meningococcal serogroup B strains. (PubMed, Diagn Microbiol Infect Dis) - "Quantification of fHbp surface expression using the MEASURE assay is robust and reproducible across different laboratories. Previously determined cutoffs corresponding to predicted susceptibility to vaccine-induced antibodies can be applied to MEASURE data generated across laboratories."

Journal • Infectious Disease • Meningococcal Infections

Penmenvy - a second pentavalent meningococcal vaccine. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Infectious Disease • Meningococcal Infections

Fluctuations in serogroup B meningococcal vaccine antigens prior to routine MenB vaccination in France. (PubMed, Commun Med (Lond)) - "IMD epidemiology is continuously changing with fluctuation in vaccine strain coverage over the 48 years prior to the routine implementation of the vaccines."

Journal • Infectious Disease • Meningococcal Infections

Molecular and WGS-based characterization of invasive Neisseria meningitidis isolates collected in Belgium (2016-2022) and MenB-FHbp vaccine coverage estimation of serogroup B. (PubMed, Vaccine) - "Coverage of the MenB-FHbp vaccine (Trumenba, bivalent rLP2086; Pfizer Inc., New York, NY, USA ipv Philadelphia) was predicted using the Meningococcal Deduced Vaccine Antigen Reactivity (MenDeVAR) index. Of the 281 MenB strains collected between 2016 and 2022, 89.1 % (lower limit - upper limit: 78.6-100.0 %) were predicted by MenDeVAR to be covered by the vaccine. This study highlights the benefits of a pathogen surveillance program and the need for experimental characterization of continuously evolving antigenic variants."

Journal • CNS Disorders • Infectious Disease • Meningococcal Infections

Safety, tolerability, and immunogenicity of pentavalent meningococcal MenABCWY vaccine in healthy infants: A phase 2b randomized clinical trial. (PubMed, Hum Vaccin Immunother) - "Immune responses for MenB test strains were higher with MenABCWY versus 4CMenB+MenACWY-TT and generally similar with 60 µg and 120 µg MenB-fHbp+MenACWY-TT or MenABCWY. Based on the limited results, the consistency of MenB immune responses with 60 µg and 120 µg MenB-fHbp suggests doses < 60 µg could be investigated to assess whether a more acceptable safety profile in conjunction with beneficial immune responses is possible in 2-month-old infants."

Clinical • Journal • P2b data • Infectious Disease • Meningococcal Infections • Pediatrics

Nanoparticles displaying fHbp elicit an enhanced antibody response against meningococcal B isolates compared to low valency fHbp antigens. (PubMed, Vaccine) - "There are currently two licensed MenB vaccines: 4CMenB (Bexsero®; GSK Vaccines, Srl, Italy) and MenB-FHbp (Trumenba®, bivalent rLP2086; Pfizer Inc., Collegeville, PA). Importantly, sera from fHbp-NP immunized mice had significantly higher serum bactericidal antibody activity against a range of MenB isolates than mice immunized with low valency antigens or MenB-FHbp. Overall, these studies demonstrate that display of fHbp on nanoparticles elicits a potent and broad antibody response."

Journal • Infectious Disease • Meningococcal Infections

New Dosing Interval and Schedule for the Bexsero MenB-4C Vaccine: Updated Recommendations of the Advisory Committee on Immunization Practices - United States, October 2024. (PubMed, MMWR Morb Mortal Wkly Rep) - "Two meningococcal serogroup B vaccines are licensed for use in the United States. ACIP recommends extending the interval for the 2-dose series of MenB-4C from 0 and ≥1 month to 0 and 6 months for healthy adolescents and young adults aged 16-23 years based on shared clinical decision-making and has added a recommendation for a 3-dose series with doses administered at 0, 1-2, and 6 months for persons aged ≥10 years at increased risk. The updated ACIP recommendations for MenB-4C align with existing ACIP recommendations for the other FDA-licensed meningococcal serogroup B vaccine, MenB-FHbp (Trumenba)."

Journal • Infectious Disease • Meningococcal Infections

Factor H binding protein (FHbp): An evaluation of genotypic diversity across Neisseria meningitidis serogroups. (PubMed, Hum Vaccin Immunother) - "Using evidence from the literature and the contemporary PubMLST database, we discuss analyses of MenB genotypes on the representation of the most prevalent multilocus sequence typing (MLST)/clonal complexes, FHbp subfamily distribution, and FHbp and porin A (PorA) variants. We further discuss that the similar genotypes, distribution, and diversity of FHbp variant types have remained stable over long time periods, supporting the potential for FHbp-containing, protein-based vaccines to protect against IMD, including MenB-FHbp (Trumenba®), which contains two lipidated FHbp antigens (one each from both FHbp subfamilies: A and B)."

Journal • Review • Infectious Disease • Meningococcal Infections

Whole-genome sequencing of Neisseria meningitidis collected in Chile from pediatric patients during 2016-2019 and coverage vaccine prediction. (PubMed, Vaccine) - "genetic variability of the Chilean strains that its different from other countries, and until now limit the coverage prediction of vaccine with the available tools like gMATS and MenDeVAR."

Journal • Infectious Disease • Meningococcal Infections • Pediatrics

A Study to Learn About How Trumenba Vaccine Shots Work Against Gonorrhea Infection in Teenagers and Young Adults in the United States. (clinicaltrials.gov) - P=N/A | N=1307378 | Completed | Sponsor: Pfizer | Recruiting ➔ Completed | N=999 ➔ 1307378

Enrollment change • Trial completion • Infectious Disease • Meningococcal Infections

Study of a Novel Multicomponent Meningococcal Group B Vaccine When Given Alone or With Other Licensed Vaccines in Adults, Adolescents, Toddlers and Infants (clinicaltrials.gov) - P1 | N=576 | Terminated | Sponsor: Sanofi Pasteur, a Sanofi Company | Phase classification: P1/2 ➔ P1

Phase classification • Infectious Disease • Meningococcal Infections

Study of a Novel Multicomponent Meningococcal Group B Vaccine When Given Alone or With Other Licensed Vaccines in Adults, Adolescents, Toddlers and Infants (clinicaltrials.gov) - P1/2 | N=576 | Terminated | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Terminated; Sponsor decision. Termination decision not related to any safety concern.

Trial termination • Infectious Disease • Meningococcal Infections

Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents (clinicaltrials.gov) - P1/2 | N=1220 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Meningococcal Infections

Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents (clinicaltrials.gov) - P1/2 | N=1220 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Initiation date: Jan 2023 ➔ Oct 2023

Trial initiation date • Infectious Disease • Meningococcal Infections

Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents (clinicaltrials.gov) - P1/2 | N=1220 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Initiation date: Oct 2023 ➔ Jan 2023

Trial initiation date • Infectious Disease • Meningococcal Infections

A Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of PF-06835375, a C-X-C chemokine receptor type 5 directed antibody, in patients with systemic lupus erythematosus or rheumatoid arthritis. (PubMed, Arthritis Res Ther) - P1 | "These data support further development of PF-06835375 to assess the clinical potential for B and Tfh cell depletion as a treatment for autoimmune diseases."

Clinical • Journal • P1 data • PK/PD data • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Meningococcal Infections • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus • Tetanus • CXCR5

UTILITY AND PUBLIC HEALTH IMPACT OF A PENTAVALENT MENINGOCOCCAL VACCINE (ESPID 2024) - "Results The MenABCWY vaccine (Penbraya TM ), comprising MenACWY (Nimenrix ® ) and MenB (Trumenba ® ), was recently licensed in the United States for 10−25-year-olds as a 2-dose schedule taken 6 months apart. Clinical data and extended interval data between doses of MenABCWY, combined with evolving IMD epidemiology data in adolescents and young adults, should be considered to develop recommendations that will simplify vaccine implementation, increase coverage, and optimize disease prevention. Funding: Pfizer"

Infectious Disease • Meningococcal Infections

BREADTH OF COVERAGE OF THE MENB-FHBP VACCINE (ESPID 2024) - "Method Clinical trial immune response data for the MenB-fHbp (Trumenba ® ) vaccine in adolescents/young adults are presented...Due to its broad coverage over disease-causing MenB strains, MenB-fHbp is currently recommended for adolescents in the United States and European countries such as the Czech Republic and Greece, as well as regional immunization programs in Italy. Funding: Pfizer"

Infectious Disease • Meningococcal Infections

Use of the Pfizer Pentavalent Meningococcal Vaccine Among Persons Aged ≥10 Years: Recommendations of the Advisory Committee on Immunization Practices - United States, 2023. (PubMed, MMWR Morb Mortal Wkly Rep) - "Two quadrivalent (serogroups A, C, W, and Y) meningococcal conjugate vaccines (MenACWY) (MenACWY-CRM [Menveo, GSK] and MenACWY-TT [MenQuadfi, Sanofi Pasteur]) and two serogroup B meningococcal vaccines (MenB) (MenB-4C [Bexsero, GSK] and MenB-FHbp [Trumenba, Pfizer Inc.]), are licensed and available in the United States and have been recommended by CDC's Advisory Committee on Immunization Practices (ACIP). Different manufacturers' serogroup B-containing vaccines are not interchangeable; therefore, when MenACWY-TT/MenB-FHbp is used, subsequent doses of MenB should be from the same manufacturer (Pfizer Inc.). This report summarizes evidence considered for these recommendations and provides clinical guidance for the use of MenACWY-TT/MenB-FHbp."

Journal • Immunology • Infectious Disease • Meningococcal Infections • Primary Immunodeficiency

A Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of MenABCWY in Healthy Infants (clinicaltrials.gov) - P2 | N=326 | Terminated | Sponsor: Pfizer | Phase classification: P2b ➔ P2

Phase classification • Infectious Disease • Meningococcal Infections

Penbraya: A pentavalent meningococcal vaccine. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Infectious Disease • Meningococcal Infections

A Study to Learn About How Trumenba Vaccine Shots Work Against Gonorrhea Infection in Teenagers and Young Adults in the United States. (clinicaltrials.gov) - P=N/A | N=999 | Recruiting | Sponsor: Pfizer | N=520392 ➔ 999 | Trial completion date: Jun 2023 ➔ Mar 2024 | Trial primary completion date: Jun 2023 ➔ Mar 2024

Enrollment change • Trial completion date • Trial primary completion date • Infectious Disease • Meningococcal Infections

A Predictive Model of Vaccine Reactogenicity Using Data from an In Vitro Human Innate Immunity Assay System. (PubMed, J Immunol) - "A forward-validation study was performed with a vaccine not used in model development, Trumenba (meningococcal group B vaccine)...Models predicting specific AEs were less accurate. Our study presents a useful framework for the further development of vaccine reactogenicity predictive models."

Journal • Preclinical • Predictive model • Infectious Disease • Meningococcal Infections • IL10 • IL1B • IL6

Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents (clinicaltrialsregister.eu) - P1/2 | N=1120 | Sponsor: Sanofi Pasteur Inc.

New P1/2 trial • Dermatology • Infectious Disease • Meningococcal Infections