Mandeep S Dhingra1, James Peterson2, James Hedrick3, Judy Pan4, David Neveu5, Emilia Jordanov6. 1. Global Clinical Sciences, Sanofi Pasteur, Swiftwater, PA 18370, USA. Electronic address: MandeepSingh.Dhingra@sanofi.com. 2. J Lewis Research, Salt Lake City, UT 84109, USA. Electronic address: jpeterson@foothillfamilyclinic.com. 3. Kentucky Pediatric and Adult Research, Bardstown, KY 40004, USA. Electronic address: jhedrick@bardstowncable.net. 4. Global Biostatistical Sciences, Sanofi Pasteur, Swiftwater, PA 18370, USA. Electronic address: judy.pan@sanofi.com. 5. Global Pharmacovigilance, Sanofi Pasteur, Swiftwater, PA 18370, USA. Electronic address: david.neveu@sanofi.com. 6. Global Clinical Sciences, Sanofi Pasteur, Swiftwater, PA 18370, USA. Electronic address: emilia.jordanov@sanofi.com.
Abstract
BACKGROUND: MenACYW-TT is an investigational quadrivalent (serogroups A, C, W and Y) meningococcal conjugate vaccine that is being developed for protection against invasive meningococcal disease. METHODS: In this Phase 3, blinded, randomized study, 3344 meningococcal vaccine-naïve 10-55-year-olds were randomized (3:3:3:2) to receive one of three lots of MenACYW-TT or licensed quadrivalent meningococcal conjugate vaccine, MCV4-DT (NCT02842853). Antibody titers were assessed by human and rabbit complement serum bactericidal antibody assays. The co-primary objectives were to demonstrate lot-to-lot consistency of MenACYW-TT by the between-lot geometric mean titer ratios (GMTR) at Day 30, and non-inferiority of Day 30 vaccine seroresponses (titers ≥ 1:16 if pre-vaccination titers < 1:8, or ≥ 4-fold increase if pre-vaccination titers ≥ 1:8) with MenACYW-TT vs MCV4-DT. Further objectives included safety and immunogenicity. RESULTS: Lot consistency was demonstrated for all three lots, with GMTRs ranging from 0.87 to 1.1. The proportion of participants achieving seroresponse in the MenACYW-TT group (data pooled from the 3 lots) was non-inferior to MCV4-DT (A: 74% vs 55%; C: 89% vs 48%; W: 80% vs 61%; Y: 91% vs 73%, respectively). MenACYW-TT and MCV4-DT had similar safety profiles; no safety concerns were identified. CONCLUSIONS: The study met both co-primary endpoints, demonstrating lot-to-lot consistency and non-inferiority of MenACYW-TT vs MCV4-DT in adolescents and adults.
BACKGROUND: MenACYW-TT is an investigational quadrivalent (serogroups A, C, W and Y) meningococcal conjugate vaccine that is being developed for protection against invasive meningococcal disease. METHODS: In this Phase 3, blinded, randomized study, 3344 meningococcal vaccine-naïve 10-55-year-olds were randomized (3:3:3:2) to receive one of three lots of MenACYW-TT or licensed quadrivalent meningococcal conjugate vaccine, MCV4-DT (NCT02842853). Antibody titers were assessed by human and rabbit complement serum bactericidal antibody assays. The co-primary objectives were to demonstrate lot-to-lot consistency of MenACYW-TT by the between-lot geometric mean titer ratios (GMTR) at Day 30, and non-inferiority of Day 30 vaccine seroresponses (titers ≥ 1:16 if pre-vaccination titers < 1:8, or ≥ 4-fold increase if pre-vaccination titers ≥ 1:8) with MenACYW-TT vs MCV4-DT. Further objectives included safety and immunogenicity. RESULTS: Lot consistency was demonstrated for all three lots, with GMTRs ranging from 0.87 to 1.1. The proportion of participants achieving seroresponse in the MenACYW-TT group (data pooled from the 3 lots) was non-inferior to MCV4-DT (A: 74% vs 55%; C: 89% vs 48%; W: 80% vs 61%; Y: 91% vs 73%, respectively). MenACYW-TT and MCV4-DT had similar safety profiles; no safety concerns were identified. CONCLUSIONS: The study met both co-primary endpoints, demonstrating lot-to-lot consistency and non-inferiority of MenACYW-TT vs MCV4-DT in adolescents and adults.
Authors: Redouane Abouqal; Maher Beji; Mohamed Chakroun; Kamal Marhoum El Filali; Jihane Rammaoui; Hela Zaghden Journal: Front Public Health Date: 2022-07-01
Authors: Carmen I Baccarini; Michael W Simon; Donald Brandon; Shane Christensen; Emilia Jordanov; Mandeep S Dhingra Journal: Pediatr Infect Dis J Date: 2020-10 Impact factor: 3.806