BACKGROUND:Neisseria meningitidis serogroup B (MnB) is a significant cause of invasive meningococcal disease. Factor H binding protein (also known as LP2086) is a conserved outer membrane neisserial lipoprotein that has emerged as a strong candidate protein antigen for MnB vaccination. This study examined the safety, tolerability and immunogenicity of an initial formulation of a bivalent recombinant LP2086 (rLP2086) vaccine in healthy children and adolescents. METHODS: In this randomized, observer-blinded, parallel-group, multicenter trial conducted at 6 centers in Australia, 127 healthy participants aged 8-14 years were assigned to receive 20, 60 or 200 µg of thebivalent rLP2086 vaccine (n = 16, 45 and 45, respectively) or active control (Twinrix, n = 21) at 0, 1 and 6 months. Immunogenicity was assessed before the first dose and 1 month after doses 2 and 3. Local reactions, systemic events and other adverse events were recorded. The primary immunogenicity endpoint was the rate of seroconversion (≥4-fold rise in human complement serum bactericidal assay titer) against MnB strains expressing the homologous A05 or heterologous B02 LP2086 variants. RESULTS: The bivalent rLP2086 vaccine was generally well-tolerated, with mostly mild to moderate local reactions. The most common adverse events, headache and upper respiratory tract infection, occurred with similar frequency in each group. Post-dose 3 seroconversion rates against strains expressing B02 and A05 variants were 68.8-95.3% for rLP2086 recipients and 0% for Twinrix recipients. CONCLUSIONS: The bivalent rLP2086 vaccine was well-tolerated and immunogenic in healthy children and adolescents, supporting further evaluation as a broadly protective MnB vaccine.
RCT Entities:
BACKGROUND:Neisseria meningitidis serogroup B (MnB) is a significant cause of invasive meningococcal disease. Factor H binding protein (also known as LP2086) is a conserved outer membrane neisserial lipoprotein that has emerged as a strong candidate protein antigen for MnB vaccination. This study examined the safety, tolerability and immunogenicity of an initial formulation of a bivalent recombinant LP2086 (rLP2086) vaccine in healthy children and adolescents. METHODS: In this randomized, observer-blinded, parallel-group, multicenter trial conducted at 6 centers in Australia, 127 healthy participants aged 8-14 years were assigned to receive 20, 60 or 200 µg of the bivalent rLP2086 vaccine (n = 16, 45 and 45, respectively) or active control (Twinrix, n = 21) at 0, 1 and 6 months. Immunogenicity was assessed before the first dose and 1 month after doses 2 and 3. Local reactions, systemic events and other adverse events were recorded. The primary immunogenicity endpoint was the rate of seroconversion (≥4-fold rise in human complement serum bactericidal assay titer) against MnB strains expressing the homologous A05 or heterologous B02 LP2086 variants. RESULTS: The bivalent rLP2086 vaccine was generally well-tolerated, with mostly mild to moderate local reactions. The most common adverse events, headache and upper respiratory tract infection, occurred with similar frequency in each group. Post-dose 3 seroconversion rates against strains expressing B02 and A05 variants were 68.8-95.3% for rLP2086 recipients and 0% for Twinrix recipients. CONCLUSIONS: The bivalent rLP2086 vaccine was well-tolerated and immunogenic in healthy children and adolescents, supporting further evaluation as a broadly protective MnB vaccine.
Authors: Gary W Zlotnick; Thomas R Jones; Paul Liberator; Li Hao; Shannon Harris; Lisa K McNeil; Duzhang Zhu; John Perez; Joseph Eiden; Kathrin U Jansen; Annaliesa S Anderson Journal: Hum Vaccin Immunother Date: 2014-11-01 Impact factor: 3.452
Authors: Lisa K McNeil; Robert J Zagursky; Shuo L Lin; Ellen Murphy; Gary W Zlotnick; Susan K Hoiseth; Kathrin U Jansen; Annaliesa S Anderson Journal: Microbiol Mol Biol Rev Date: 2013-06 Impact factor: 11.056
Authors: Henju Marjuki; How-Yi Chang; Nadav Topaz; Melissa J Whaley; Jeni Vuong; Alexander Chen; Laurel T Jenkins; Fang Hu; Susanna Schmink; Adam C Retchless; Jennifer D Thomas; Anna M Acosta; Lucy A McNamara; Heidi M Soeters; Sarah Mbaeyi; Xin Wang Journal: mBio Date: 2021-05-18 Impact factor: 7.867
Authors: Lisa A Lewis; David M Vu; Shreekant Vasudhev; Jutamas Shaughnessy; Dan M Granoff; Sanjay Ram Journal: MBio Date: 2013-10-15 Impact factor: 7.867
Authors: Robert M Mulhall; Carina Brehony; Lois O'Connor; Kenneth Meyler; Keith A Jolley; James Bray; Desiree Bennett; Martin C J Maiden; Robert Cunney Journal: J Clin Microbiol Date: 2016-09-14 Impact factor: 5.948