A Bivalent Meningococcal B Vaccine in Adolescents and Young Adults
Lars Ostergaard, Timo Vesikari, Judith Absalon, Johannes Beeslaar, Brian J Ward, Shelly Senders, Joseph J Eiden, Kathrin U Jansen, Annaliesa S Anderson, Laura J York, Thomas R Jones, Shannon L Harris, Robert O'Neill, David Radley, Roger Maansson, Jean-Louis Prégaldien, John Ginis, Nina B Staerke, John L Perez, B1971009 and B1971016 Trial Investigators, J Belle-Isle, E Elfassi, P Fredette, H Garfield, G Girard, P Lachance, E Adamkova, E Bartonova, D Drazan, J Dvorakova, P Kosina, A Kyjonkova, R Ruzkova, E Vitousova, A Ahonen, A Forsten, T Karppa, S Kokko, P-M Lagerstrom-Tirri, J K Simila, T Adelt, U Behre, T F Schwarz, P Castiglia, S Esposito, G Ferrera, G Icardi, J Brzostek, B Hasiec, R Konior, J Pejcz, H Szymanski, A Witor, S N Faust, A H Finn, P T Heath, A J Pollard, D D Altamirano, C T Ashley Jr, G F Bader, G H Bauer Jr, S L Block Jr, D M Brandon, M G Davis, O DeValle, R H Egelhof, B J Essink, B B Fouch, B P Fox, E R Franklin, A G Garscadden, U P Goswami, D M Gregory, L L Helman, V G Houchin, C E Howard, A D Johnson, W H Johnston Jr, C A Jordan, M A Kimmel, T R Klein, L R Krilov, A P LaBarbera, J M Labuda II, T G Latiolais, L G Lello, D H Lewis, J A Ley, A L London, M S Martin, M R McGuire, V C Mosteller, T R Naccarato, C G Nassim, M R Rey, R A Robbins, K G Rouse, M J Schear, S D Senders, J S Shepard, M W Simpson, A J Slandzicki, S B Slechta, L L Tetrick, M Varman, L T Wadsworth III, D B Ware, J H White, P P Wisman Jr, F Blouin, M Dionne, P Dzongowski, K J Heaton, J M Langley, M F J O'Mahony, C N Powell, B J Ward, L J Ostergaard, T L Haapaniemi, M Paassilta, I K Volanen, T Lepich, E Smukalska, I Tarczon, B M Tetiurka, J D Domingo, A V Morato, M T Riera, C A Sanchez, J M R Torrell, J Blumenau, N G Campbell, J A Cervantes, W G Douglas, D J Ensz, J E Ervin, T C Fiel, V G Fragoso, D L Fried, G P Gleason, S L Green, A Z Haggag, C T Johnson, R S Khaira, J L Kirstein, A E Kravitz, S N Lederman, I Marcadis, V E Miller, J M Moretti, A A Pragalos, A D Puopolo, J Rubino, D J Seiden, S C Sharp, E A Sheldon, G R Shockey, W B Smith, J C Stringer, C B Strout, H E Studdard, N J L Tresser, Lars Ostergaard, Timo Vesikari, Judith Absalon, Johannes Beeslaar, Brian J Ward, Shelly Senders, Joseph J Eiden, Kathrin U Jansen, Annaliesa S Anderson, Laura J York, Thomas R Jones, Shannon L Harris, Robert O'Neill, David Radley, Roger Maansson, Jean-Louis Prégaldien, John Ginis, Nina B Staerke, John L Perez, B1971009 and B1971016 Trial Investigators, J Belle-Isle, E Elfassi, P Fredette, H Garfield, G Girard, P Lachance, E Adamkova, E Bartonova, D Drazan, J Dvorakova, P Kosina, A Kyjonkova, R Ruzkova, E Vitousova, A Ahonen, A Forsten, T Karppa, S Kokko, P-M Lagerstrom-Tirri, J K Simila, T Adelt, U Behre, T F Schwarz, P Castiglia, S Esposito, G Ferrera, G Icardi, J Brzostek, B Hasiec, R Konior, J Pejcz, H Szymanski, A Witor, S N Faust, A H Finn, P T Heath, A J Pollard, D D Altamirano, C T Ashley Jr, G F Bader, G H Bauer Jr, S L Block Jr, D M Brandon, M G Davis, O DeValle, R H Egelhof, B J Essink, B B Fouch, B P Fox, E R Franklin, A G Garscadden, U P Goswami, D M Gregory, L L Helman, V G Houchin, C E Howard, A D Johnson, W H Johnston Jr, C A Jordan, M A Kimmel, T R Klein, L R Krilov, A P LaBarbera, J M Labuda II, T G Latiolais, L G Lello, D H Lewis, J A Ley, A L London, M S Martin, M R McGuire, V C Mosteller, T R Naccarato, C G Nassim, M R Rey, R A Robbins, K G Rouse, M J Schear, S D Senders, J S Shepard, M W Simpson, A J Slandzicki, S B Slechta, L L Tetrick, M Varman, L T Wadsworth III, D B Ware, J H White, P P Wisman Jr, F Blouin, M Dionne, P Dzongowski, K J Heaton, J M Langley, M F J O'Mahony, C N Powell, B J Ward, L J Ostergaard, T L Haapaniemi, M Paassilta, I K Volanen, T Lepich, E Smukalska, I Tarczon, B M Tetiurka, J D Domingo, A V Morato, M T Riera, C A Sanchez, J M R Torrell, J Blumenau, N G Campbell, J A Cervantes, W G Douglas, D J Ensz, J E Ervin, T C Fiel, V G Fragoso, D L Fried, G P Gleason, S L Green, A Z Haggag, C T Johnson, R S Khaira, J L Kirstein, A E Kravitz, S N Lederman, I Marcadis, V E Miller, J M Moretti, A A Pragalos, A D Puopolo, J Rubino, D J Seiden, S C Sharp, E A Sheldon, G R Shockey, W B Smith, J C Stringer, C B Strout, H E Studdard, N J L Tresser
Abstract
Background: MenB-FHbp is a licensed meningococcal B vaccine targeting factor H-binding protein. Two phase 3 studies assessed the safety of the vaccine and its immunogenicity against diverse strains of group B meningococcus.
Methods: We randomly assigned 3596 adolescents (10 to 18 years of age) to receive MenB-FHbp or hepatitis A virus vaccine and saline and assigned 3304 young adults (18 to 25 years of age) to receive MenB-FHbp or saline at baseline, 2 months, and 6 months. Immunogenicity was assessed in serum bactericidal assays that included human complement (hSBAs). We used 14 meningococcal B test strains that expressed vaccine-heterologous factor H-binding proteins representative of meningococcal B epidemiologic diversity; an hSBA titer of at least 1:4 is the accepted correlate of protection. The five primary end points were the proportion of participants who had an increase in their hSBA titer for each of 4 primary strains by a factor of 4 or more and the proportion of those who had an hSBA titer at least as high as the lower limit of quantitation (1:8 or 1:16) for all 4 strains combined after dose 3. We also assessed the hSBA responses to the primary strains after dose 2; hSBA responses to the 10 additional strains after doses 2 and 3 were assessed in a subgroup of participants only. Safety was assessed in participants who received at least one dose.
Results: In the modified intention-to-treat population, the percentage of adolescents who had an increase in the hSBA titer by a factor of 4 or more against each primary strain ranged from 56.0 to 85.3% after dose 2 and from 78.8 to 90.2% after dose 3; the percentages of young adults ranged from 54.6 to 85.6% and 78.9 to 89.7%, after doses 2 and 3, respectively. Composite responses after doses 2 and 3 in adolescents were 53.7% and 82.7%, respectively, and those in young adults were 63.3% and 84.5%, respectively. Responses to the 4 primary strains were predictive of responses to the 10 additional strains. Most of those who received MenB-FHbp reported mild or moderate pain at the vaccination site.
Conclusions: MenB-FHbp elicited bactericidal responses against diverse meningococcal B strains after doses 2 and 3 and was associated with more reactions at the injection site than the hepatitis A virus vaccine and saline. (Funded by Pfizer; ClinicalTrials.gov numbers, NCT01830855 and NCT01352845 ).
Source: PubMed