MenB-FHbp Vaccine Protects Against Diverse Meningococcal Strains in Adolescents and Young Adults: Post Hoc Analysis of Two Phase 3 Studies

Autor: Johannes Beeslaar, Judith Absalon, Annaliesa S. Anderson, Joseph J. Eiden, Paul Balmer, Shannon L. Harris, Thomas R. Jones, Robert E. O’Neill, Jean-Louis Pregaldien, David Radley, Roger Maansson, John Ginis, Amit Srivastava, John L. Perez
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Zdroj: Infectious Diseases and Therapy, Vol 9, Iss 3, Pp 641-656 (2020)
Druh dokumentu: article
ISSN: 2193-8229
2193-6382
DOI: 10.1007/s40121-020-00319-0
Popis: Abstract Introduction Two phase 3 studies in adolescents and young adults demonstrated that MenB-FHbp, a meningococcal serogroup B (MenB) vaccine, elicits protective immune responses after 2 or 3 doses based on serum bactericidal antibody assays using human complement (hSBA) against 4 primary and 10 additional diverse, vaccine-heterologous MenB test strains. Lower limits of quantitation (LLOQs; titers 1:8 or 1:16; titers ≥ 1:4 correlate with protection) were used to evaluate responses to individual strains and all 4 primary strains combined (composite response). A post hoc analysis evaluated percentages of subjects with protective responses to as many as 8 strains combined (4 primary plus additional strains). Methods Immune responses were measured using hSBAs against 4 primary strains in adolescents (n = 1509, MenB-FHbp; n = 898, hepatitis A virus vaccine/saline) and young adults (n = 2480, MenB-FHbp; n = 824, saline) receiving MenB-FHbp or control at 0, 2, and 6 months. Ten additional strains were evaluated in subsets of subjects from approximately 1800 MenB-FHbp recipients across both studies. Percentages of subjects with hSBA titers ≥ LLOQ for different numbers of primary strains or primary plus additional strains combined (7 or 8 strains total per subset) were determined before vaccination, 1 month post-dose 2, and 1 month post-dose 3. Results Across the panel of primary plus additional strains, at 1 month post-dose 3, titers ≥ LLOQ were elicited in 93.7–95.7% of adolescents and 91.7–95.0% of young adults for ≥ 5 test strains combined and in 70.5–85.8% of adolescents and 67.5–81.4% of young adults for ≥ 7 strains combined. Among adolescents, 99.8%, 99.0%, 92.8%, and 82.7% had titers ≥ LLOQ against at least 1, 2, 3, and all 4 primary strains, respectively; corresponding percentages for young adults were 99.7%, 97.7%, 94.0%, and 84.5%. Conclusions Results support the ability of MenB-FHbp to provide broad coverage against MenB strains expressing diverse FHbp variants. Trial Registration ClinicalTrials.gov identifiers NCT01830855, NCT01352845.
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