AI Article Synopsis
- MenB-FHbp is a vaccine for meningococcal serogroup B, showing sustained immune response over time, with hSBA (human serum bactericidal antibody) titers lasting up to 4 years after initial vaccination and around 2 years post-booster.
- A power law model (PLM) was created to project hSBA titers for 5 years after both the primary series and booster doses, utilizing data from earlier clinical trials involving healthy adolescents.
- Findings suggest that between 15.2%-50.0% of individuals maintain adequate hSBA titers (≥1:8) at the 5-year mark post-primary vaccination, and 51.2%-70.9
Article Abstract
MenB-FHbp is a meningococcal serogroup B vaccine. Persistence of hSBA titers against 4 diverse test strains ≤ 4 years after a 2-dose MenB-FHbp primary series and ≤ 26 months after a booster dose administered 4 years post-primary has been demonstrated. Here, we developed a power law model (PLM) to estimate the persistence of hSBA titers up to 5 years after a MenB-FHbp primary series and a booster dose using hSBA data from previous MenB-FHbp clinical trials in healthy adolescents. The PLM-predicted hSBA titers closely followed observed values after a 0, 6 month MenB-FHbp primary series and a booster dose 4 years later. At 5 years post-primary and 5 years post-booster, the PLM predicted that 15.2 %-50.0 % and 51.2 %-70.9 % of individuals, respectively, would have hSBA titers ≥ 1:8 or 1:16. The PLM supports that the persistence of hSBA titers is maintained for at least 5 years post-primary MenB-FHbp vaccination and post-booster.
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| http://dx.doi.org/10.1016/j.vaccine.2023.02.078 | DOI Listing |
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Article Synopsis
- The study evaluates a new meningococcal vaccine (MenABCWY) that combines components of the existing MenB vaccine (4CMenB) and the MenACWY vaccine, aiming to provide broad immunization against various meningococcal strains and ease vaccination schedules.
- Conducted as a phase 3 randomized trial across multiple countries, healthy participants aged 10-25 were assigned to receive different vaccine schedules to assess safety, immune response, and consistency of vaccine lots.
- The trial primarily focused on the immune response to MenB strains, comparing MenABCWY's effectiveness to 4CMenB and evaluating the consistency of immune responses among different production lots of the vaccines.
Immune persistence and booster response of a quadrivalent meningococcal conjugate vaccine (MenACYW-TT) 5 years after primary vaccination of adults at ≥56 years of age.
Hum Vaccin Immunother
December 2024
Global Medical Affairs, Sanofi, Lyon, France.
Stage I of this study (NCT04142242) demonstrated the safety and immunogenicity of a booster dose of a licensed quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) and immune persistence 3 and 6-7 years after priming in older adults who received either quadrivalent meningococcal polysaccharide vaccine (MPSV4) or MenACYW-TT at ≥56 years of age. Stage II, reported here, assessed the antibody persistence after MenACYW-TT versus MPSV4 priming and the safety and immunogenicity of a booster dose of MenACYW-TT in older adults 5 years after primary vaccination with either MPSV4 or MenACYW-TT. A serum bactericidal assay (hSBA) was used to measure functional antibodies against each serogroup immediately before MenACYW-TT booster vaccination and on day (D) 30 post-booster.
View Article and Find Full Text PDFRandomized trial showing persistence of hSBA titers elicited by a pentavalent meningococcal MenABCWY vaccine for up to 4 years following a primary series and safety and immunogenicity of a booster dose.
Vaccine
January 2025
Pfizer R&D UK Limited, Orega, Marlow International, Parkway, Marlow, SL7 1YL, UK,. Electronic address:
Background: Vaccination against 5 prominent meningococcal serogroups (A/B/C/W/Y) is necessary for broad disease protection. We report immunopersistence through 4 years after a 2-dose (6-month interval) pentavalent MenABCWY primary vaccine series and safety and immunogenicity of a booster administered 4 years after primary vaccination.
Methods: This randomized, active-controlled, observer-blinded study was conducted in the United States and Europe.
Effectiveness and duration of protection of primary and booster immunisation against meningococcal serogroup C disease with meningococcal conjugate C and ACWY vaccines: Systematic review.
J Infect
September 2024
Robert Koch Institute, Immunisation Unit, Seestrasse 10, 13353 Berlin, Germany. Electronic address:
Objectives: To estimate vaccine effectiveness (VE) and duration of protection of single primary and booster immunisation with meningococcal C (MenC) and ACWY (MenACWY) conjugate vaccines in preventing MenC invasive meningococcal disease (IMD).
Methods: We performed a systematic review on studies of VE and immunogenicity (rSBA/hSBA titers) of participants aged 12-23 months for primary and 6-18 years for booster immunisation (last search: 18 August 2023). Risk of bias and certainty of evidence were evaluated (PROSPERO: CRD42020178773).
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix in Healthy Adolescents: A Randomized Phase IIIb Multicenter Study.
Infect Dis Ther
August 2024
Isabelle Betrand-Gerentes, Global Medical, Sanofi Vaccines, 14 Espa. Henry Vallée, 69007, Lyon, France.
Introduction: Many immunization programs in Europe recommend quadrivalent meningococcal vaccinations, which are often administered concomitantly with other vaccines. We compared the immune response of a tetanus toxoid conjugated quadrivalent meningococcal vaccine (MenACYW-TT, MenQuadfi) with another quadrivalent meningococcal conjugate vaccine (MCV4-TT; Nimenrix) when administered alone or concomitantly with Tdap-IPV and 9vHPV vaccines in adolescents.
Methods: In this phase IIIb trial, healthy adolescents (MenC-naïve or MenC-primed before 2 years of age) from Spain, Italy, Hungary, and Singapore were randomized in a 3:3:2 ratio to receive either MenACYW-TT or MCV4-TT alone, or MenACYW-TT concomitantly with 9vHPV and Tdap-IPV.
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