P-1496. Antibody Persistence of the 4CMenB Vaccine in Infants: A Systematic Literature Review

Abstract Background Invasive meningococcal disease (IMD) incidence is highest in infants aged 1 year, often caused by meningococcal serogroup B (MenB). The multicomponent MenB vaccine (4CMenB) contains 4 antigenic components (factor H binding protein fHbp, Neisseria adhesion A NadA, Neisseria heparin-binding antigen NHBA, and outer membrane vesicles with Porin A PorA). This systematic literature review aimed to establish evidence-based ranges for 4CMenB antibody persistence after infant (age 0–12 months m) vaccination. Methods MEDLINE, Embase, gray literature, and clinical trial registries were searched using prespecified criteria following PRISMA guidelines. Antibody persistence was defined as the percentage of participants with human serum bactericidal activity titers ≥ 4 or 5 against the 4CMenB antigenic components expressed in MenB strains H44/76 (fHbp), 5/99 (NadA), NZ98/254 (OMV PorA), and M10713 (NHBA). Results Fifteen included studies (8 trials, 7 extensions; Table 1) reported antibody persistence over time and enrolled 30–3,630 participants. Variations of 2-/3-dose primary series and 3+1/2+1 booster schedules were evaluated. Antibody levels were reported from pre-vaccination up to 120m post-vaccination. Pre-vaccination, antibody persistence was low: 0–29% (fHbp), 0–14% (NadA), 0–13% (PorA), and 10–35% (NHBA). Antibody persistence 1m after last dose was high across schedules and antigens: 87–100% (fHbp), 95–100% (NadA), 70–100% (PorA), and 49–97% (NHBA). Antibody persistence against NadA remained highest over time and against PorA decreased most rapidly. At 6–8m following last primary dose, 30–87% (fHbp), 86–100% (NadA), 11–54% (PorA), and 22–33% (NHBA) of individuals had antibody persistence. Following booster, persistence was: 62% (fHbp), 97% (NadA), 17% (PorA), and 36% (NHBA) at 12m; 12–65% (fHbp), 76–100% (NadA), 9–56% (PorA), and 36–79% (NHBA) at 24–36m; and 0% (fHbp), 33–40% (NadA), and 0% (PorA) at 120m (Table 1). Conclusion There is strong evidence to support persistence (9–93%) of individual antibodies induced by 4CMenB (not accounting for any synergistic effect across antigens) for ≥ 36m with some evidence suggesting up to 120m (10 years) for NadA. Persistence was consistent between 2+1 and 3+1 schedules. Funding: GSK VEO-001056 Disclosures Pavo Marijic, PhD, GSK: employee|GSK: Stocks/Bonds (Public Company) Lucian Gaianu, MSc, GSK: Employee Gaurav Mathur, MD, GSK: Employee|GSK: Stocks/Bonds (Public Company) Luca Moraschini, PhD, GSK: Employee|GSK: Stocks/Bonds (Public Company) Thatiana Pinto, PhD, GSK: employee|GSK: Stocks/Bonds (Public Company) Anar Andani, BSc, Medical director, GSK: Employee|GSK: Stocks/Bonds (Public Company) Elise Kuylen, PhD, GSK: Employee|GSK: Stocks/Bonds (Public Company) Karolina Szewczyk, MSc, GSK: Employee of Clever-Access, which was paid by GSK to conduct this study Elzbieta Olewinska, MSc, GSK: Employee of Clever-Access, which was paid by GSK to conduct this study Beata Smela, PhD, GSK: Employee of Clever-Access, which was paid by GSK to conduct this study Helen Petousis-Harris, PhD, Bexsero and gonorrhea trial (USA): Data and Safety Monitory Board Member|CDC: Funding to institution|GSK: Advisor/Consultant|GSK: Funding to institution; payment for study|Maternal pneumococcal vaccine trial (Australia): Data and Safety Monitory Board Member|New Zealand Medical Council: Advisor/Consultant|The Ministry of Health New Zealand: Funding to institution Stefano Castagna, PhD, GSK: Employee|GSK: Stocks/Bonds (Public Company) Zeki Kocaata, PhD, GSK: Employee|GSK: Stocks/Bonds (Public Company)