P-1467. Clinical Development of MenABCWY (PenbrayaTM), a Broadly Protective Pentavalent Meningococcal Vaccine

TL;DR

A new meningococcal vaccine called MenABCWY is shown to be safe and effective in inducing strong immune responses in young adults.

Contribution

The paper presents clinical data demonstrating the efficacy and safety of the first-in-class pentavalent meningococcal vaccine MenABCWY.

Findings

MenABCWY induces robust immune responses comparable to or better than existing MenACWY and MenB vaccines.

Seroprotection rates remain high even with extended dosing intervals up to 36 months.

The vaccine is well tolerated with no significant safety concerns observed.

Abstract

The first-in-class pentavalent meningococcal serogroup A/B/C/W/Y vaccine (MenABCWY; PenbrayaTM) received US licensure in 2023 as a 2-dose, 0,6-month (m) series for individuals 10‒25 years (y) of age. Here we review data supporting MenABCWY licensure and utility.

Three phase 1/2b/3 MenABCWY studies included a total of > 4000 MenB vaccine–naive, MenACWY vaccine–naive or –experienced participants 10‒25 y of age. Immune responses were assessed as serum bactericidal antibody using human complement (hSBA) against MenA/C/W/Y strains and 4 diverse, vaccine-heterologous MenB strains; endpoints included seroprotection (titers ≥ 1:8 or ≥ 1:16, depending on strain) and seroresponse (≥ 4-fold titer rise from baseline) rates and geometric mean titers (GMTs). Safety was also assessed.

MenB hSBA seroresponse (68.1%‒95.9%) and composite response rates (78.3%; seroprotection for all 4 strains) after Dose 2 of a 0,6m MenABCWY series were similar to or higher than after 2 MenB-fHbp doses (Fig 1A), achieving noninferiority at the −10% margin. Results were similar for MenA/C/W/Y seroresponse rates after each MenABCWY dose among MenACWY-naive (Dose 1, 62.9%‒97.0%; Dose 2, 93.3%‒97.8%; Fig 1B) and -experienced participants compared with after 1 MenACWY-CRM dose. Seroprotection rates after a 0,6m MenABCWY series were similar to or higher than for MenACWY-CRM+MenB-fHbp through 4 y and indicated anamnestic responses to a MenABCWY booster at 4 y (MenB, ≥ 95.1%; MenA/C/W/Y, 100%; Fig 2). Extended 12-m and 36-m MenABCWY dosing intervals led to ≥ 96.6% MenA/B/C/W/Y seroprotection rates (Fig 3); GMTs (Fig 4) and seroresponse rates generally trended higher as the interval increased from 6 to 36 m. Seroprotection rates through 24 m after the 0,12m series were similar to or higher than for the 0,6m series (Fig 2). MenABCWY was well tolerated; there were no safety concerns.

MenABCWY is well tolerated with an acceptable safety profile. A 0,6m MenABCWY series induces robust immune responses that are similar to or higher than for separate MenACWY and MenB vaccines through 4 y, boostable, and remain similar or increase with longer dosing intervals up to 36 m. These results suggest comprehensive protection and flexibility for meningococcal vaccination using a single vaccine. Funded by Pfizer.

Lefteris Zolotas, MD, Pfizer Inc: Employee Ashlesh Murthy, MD, Pfizer Inc: Employee|Pfizer Inc: Stocks/Bonds (Public Company) Roger Maansson, MS, Pfizer Inc: Employee Ryan Newton, BSC/MBA, Pfizer Inc: Employee Kelly Belanger, BS, Pfizer Inc: Employee Yanping Liu, PhD, Pfizer Inc: Employee Robert O’Neill, PhD, Pfizer Inc: Employee Mark W. Cutler, PhD, Pfizer Inc: Employee Annaliesa S. Anderson, PhD, Pfizer Inc: Employee Johannes Beeslaar, MD, Pfizer Inc: Employee

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