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Immune Responses to Booster Vaccination with Meningococcal ABCWY Vaccine Following Primary Vaccination with Either Investigational or Licensed Vaccines: A Phase 2 Randomized Study

Szenborn Leszek MD; Block,, Stan L. MD; Jackowska, Teresa MD; Konior, Ryszard; D'Agostino, Diego M Sc; Smolenov, Igor MD; Toneatto, Daniela PhD; Welsch, Jo Anne PhD
The Pediatric Infectious Disease Journal: Post Acceptance: January 11, 2018
doi: 10.1097/INF.0000000000001896
Vaccine Reports: PDF Only

Background:

Current meningococcal prime-boost vaccination schedules include separate vaccines for serogroups ACWY and B. An investigational combined serogroups ABCWY vaccine (MenABCWY) was developed to protect against clinically important Neisseria meningitidis serogroups.

Methods:

In this phase 2, randomized, observer-blind, extension study (NCT01272180), participants aged 10–25 years received 1 booster dose of MenABCWY vaccine at 24 months (M) post-primary series of either MenABCWY (2 doses), 4CMenB (2 doses) or MenACWY-CRM vaccine (1 dose). Immune responses to booster dose (1M post-booster) and antibody persistence (24M, 36M post-primary series) were assessed using bactericidal assay with human complement (hSBA). Reactogenicity and safety were evaluated.

Results:

190 participants were vaccinated. At 1M after the MenABCWY booster dose, seroresponse rates against serogroups ACWY ranged between 85% and 96%, 73% and 100%, and 83% and 95% for participants previously receiving MenABCWY, 4CMenB and MenACWY-CRM, respectively. At 12M post-booster dose, ≥67% of participants across all groups had hSBA titres ≥8 for serogroups ACWY, except in 4CMenB-primed individuals for serogroup Y (45%). Across MenABCWY and 4CMenB-primed groups, hSBA titres ≥5 across serogroup B test strains were observed in 82–100% and 29–100% of participants at 1M and 12M post-booster, respectively. Geometric mean titres against serogroups ACWY increased from pre- to 1M post-boosting with MenABCWY and persisted at 12M. The reactogenicity and safety profile of MenABCWY was similar to that of 4CMenB.

Conclusions:

MenABCWY may be suitable for prime-boost schedules against meningococcal disease, including regimens involving a primary series of either 4CMenB or MenACWY-CRM licensed vaccines.

* Current affiliation: Valera, a Moderna venture, Cambridge MA, United States.

** Current affiliation: PATH, San Francisco, CA, United States; 2 Moderna Therapeutics, Cambridge, MA, United States

Source of funding: Novartis Vaccines and Diagnostics Inc., now part of the GSK group of companies provided financial support for the conduct of the research including study design as well as data collection, analysis and interpretation. GSK group of companies paid all costs associated with the manuscript development.

Author disclosures: DD’A and DT are GSK employees. JAW was a GSK employee at the time of the study. IS was an employee of Novartis Vaccines (now part of the GSK group of companies) at the time of the study. SLB is a grant investigator and received a research grant from Novartis Vaccines (now part of the GSK group of companies). LS received personal fees from Novartis and GSK groups of companies during the conduct of the study. TJ and RK report no conflicts of interest.

Acknowledgements: The authors thank all of the participants, their families and the study staffs at the research centres for contributing to this study. The authors would like to acknowledge Hanna Czajka and Wendy Daly for their participation in the conduct of this study as well as Linda Han, Julie Densmore and Gordon Brestrich for their contribution to the study. Publication management and medical writing support for this manuscript were provided by Olivier Box, Petronela M. Petrar and Annick Moon (XPE Pharma & Science, Wavre, Belgium, c/o GSK).

Authors’ contribution: IS, and DD’A designed the study. SLB, LS, RK, TJ, JW and IS conducted the study and participated in the acquisition of data. DD’A and IS provided biostatistical expertise. All authors participated in the analysis and interpretation of the data, in the development of the draft and approved the submitted version of the manuscript.

Conflicts of interest: DD’A, JAW and DT are GSK employees. IS was an employee of Novartis Vaccines (now part of the GSK group of companies) at the time of the study. SLB is a grant investigator and received a research grant from Novartis Vaccines (now part of the GSK group of companies). LS received personal fees from Novartis and GSK groups of companies during the conduct of the study. TJ and RK report no conflicts of interest.

Corresponding author: Jo Anne Welsch, PATH, 600 California Street, 14th Floor, San Francisco, CA 94108, United States; e-mail: jwelsch@path.org; Phone: +001-510-384-3540

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