1. A Bivalent Meningococcal B Vaccine in Adolescents and Young Adults
- Author
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Ostergaard, L., Vesikari, T., Absalon, J., Beeslaar, J., Ward, B. J., Senders, S., Eiden, J. J., Jansen, K. U., Anderson, A. S., York, L. J., Jones, T. R., Harris, S. L., O'Neill, R., Radley, D., Maansson, R., Pregaldien, J. -L., Ginis, J., Staerke, N. B., Perez, J. L., Belle-Isle, J, Elfassi, E, Fredette, P, Garfield, H, Girard, G, Lachance, P, Adamkova, E, Bartonova, E, Drazan, D, Dvorakova, J, Kosina, P, Kyjonkova, A, Ruzkova, R, Vitousova, E, Ahonen, A, Forsten, A, Karppa, T, Kokko, S, Lagerstrom-Tirri, Pm, Simila, Jk, Adelt, T, Behre, U, Schwarz, Tf, Castiglia, P, Esposito, S, Ferrera, G, Icardi, G, Brzostek, J, Hasiec, B, Konior, R, Pejcz, J, Szymanski, H, Witor, A, Faust, Sn, Finn, Ah, Heath, Pt, Pollard, Aj, Altamirano, Dd, Ashley CT Jr, Bader, Gf, Bauer GH Jr, Block SL Jr, Brandon, Dm, Davis, Mg, Devalle, O, Egelhof, Rh, Essink, Bj, Fouch, Bb, Fox, Bp, Franklin, Er, Garscadden, Ag, Goswami, Up, Gregory, Dm, Helman, Ll, Houchin, Vg, Howard, Ce, Johnson, Ad, Johnston WH Jr, Jordan, Ca, Kimmel, Ma, Klein, Tr, Krilov, Lr, Labarbera, Ap, Labuda JM II, Latiolais, Tg, Lello, Lg, Lewis, Dh, Ley, Ja, London, Al, Martin, Ms, Mcguire, Mr, Mosteller, Vc, Naccarato, Tr, Nassim, Cg, Rey, Mr, Robbins, Ra, Rouse, Kg, Schear, Mj, Senders, Sd, Shepard, Js, Simpson, Mw, Slandzicki, Aj, Slechta, Sb, Tetrick, Ll, Varman, M, Wadsworth LT III, Ware, Db, White, Jh, Wisman PP Jr, Blouin, F, Dionne, M, Dzongowski, P, Heaton, Kj, Langley, Jm, O'Mahony, Mfj, Powell, Cn, Ward, Bj, Ostergaard, Lj, Haapaniemi, Tl, Paassilta, M, Volanen, Ik, Lepich, T, Smukalska, E, Tarczon, I, Tetiurka, Bm, Domingo, Jd, Morato, Av, Riera, Mt, Sanchez, Ca, Torrell, Jmr, Blumenau, J, Campbell, Ng, Cervantes, Ja, Douglas, Wg, Ensz, Dj, Ervin, Je, Fiel, Tc, Fragoso, Vg, Fried, Dl, Gleason, Gp, Green, Sl, Haggag, Az, Johnson, Ct, Khaira, Rs, Kirstein, Jl, Kravitz, Ae, Lederman, Sn, Marcadis, I, Miller, Ve, Moretti, Jm, Pragalos, Aa, Puopolo, Ad, Rubino, J, Seiden, Dj, Sharp, Sc, Sheldon, Ea, Shockey, Gr, Smith, Wb, Stringer, Jc, Strout, Cb, Studdard, He, and Tresser, Njl.
- Subjects
Male ,0301 basic medicine ,Clinical Trial, Phase III ,Hepatitis A vaccine ,Neisseria meningitidis, Serogroup B ,Neisseria meningitidis ,medicine.disease_cause ,bacterial protein ,Group B ,0302 clinical medicine ,Single-Blind Method ,030212 general & internal medicine ,Child ,Phylogeny ,biology ,Immunogenicity ,Bacterial ,General Medicine ,hepatitis A vaccine ,Meningococcus vaccine ,bacterial antigen ,bacterium antibody ,factor H-binding protein, Neisseria meningitidis ,Antibodies, Bacterial ,Intention to Treat Analysis ,Multicenter Study ,Titer ,Randomized Controlled Trial ,factor H-binding protein ,Female ,Antibody ,Adult ,Adolescent ,Fever ,Serogroup B ,030106 microbiology ,Meningococcal Vaccines ,Meningococcal vaccine ,Antibodies ,Young Adult ,03 medical and health sciences ,Bacterial Proteins ,Journal Article ,medicine ,Antigens, Bacterial ,Humans ,Meningococcal Infections ,Antigens ,business.industry ,Immunology ,biology.protein ,Bacterial antigen ,business - 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 ).
- Published
- 2017