title: Immunogenicity, Safety, and Tolerability of Bivalent rLP2086 Meningococcal Group B Vaccine Administered Concomitantly With Diphtheria, Tetanus, and Acellular Pertussis and Inactivated Poliomyelitis Vaccines to Healthy Adolescents.
abstract: CONCLUSIONS
  Concomitant administration of bivalent rLP2086 (Trumenba [Pfizer, Inc] and diphtheria, tetanus, and acellular pertussis and inactivated poliovirus vaccine (DTaP/IPV) was immunologically noninferior to DTaP/IPV and saline and was safe and well tolerated. Bivalent rLP2086 elicited robust and broad bactericidal antibody responses to diverse Neisseria meningitidis serogroup B strains expressing antigens heterologous to vaccine antigens after 2 and 3 vaccinations.
  
  
  BACKGROUND
  Bivalent rLP2086, a Neisseria meningitidis serogroup B (MnB) vaccine (Trumenba [Pfizer, Inc]) recently approved in the United States to prevent invasive MnB disease in individuals aged 10-25 years, contains recombinant subfamily A and B factor H binding proteins (fHBPs). This study evaluated the coadministration of Repevax (diphtheria, tetanus, and acellular pertussis and inactivated poliovirus vaccine [DTaP/IPV]) (Sanofi Pasteur MSD, Ltd) and bivalent rLP2086.
  
  
  METHODS
  Healthy adolescents aged ≥11 to <19 years received bivalent rLP2086 + DTaP/IPV or saline + DTaP/IPV at month 0 and bivalent rLP2086 or saline at months 2 and 6. The primary end point was the proportion of participants in whom prespecified levels of antibodies to DTaP/IPV were achieved 1 month after DTaP/IPV administration. Immune responses to bivalent rLP2086 were measured with serum bactericidal assays using human complement (hSBAs) against 4 MnB test strains expressing fHBP subfamily A or B proteins different from the vaccine antigens.
  
  
  RESULTS
  Participants were randomly assigned to receive bivalent rLP2086 + DTaP/IPV (n = 373) or saline + DTaP/IPV (n = 376). Immune responses to DTaP/IPV in participants who received bivalent rLP2086 + DTaP/IPV were noninferior to those in participants who received saline + DTaP/IPV.The proportions of bivalent rLP2086 + DTaP/IPV recipients with prespecified seroprotective hSBA titers to the 4 MnB test strains were 55.5%-97.3% after vaccination 2 and 81.5%-100% after vaccination 3. The administration of bivalent rLP2086 was well tolerated and resulted in few serious adverse events.
  
  
  CONCLUSIONS
  Immune responses to DTaP/IPV administered with bivalent rLP2086 to adolescents were noninferior to DTaP/IPV administered alone. Bivalent rLP2086 was well tolerated and elicited substantial and broad bactericidal responses to diverse MnB strains in a high proportion of recipients after 2 vaccinations, and these responses were further enhanced after 3 vaccinations.ClinicalTrials.gov identifier NCT01323270.
authors.affiliation: Vaccine Research Centre, University of Tampere Medical School, Finland.
authors.forename: Timo
authors.initials: T
authors.lastname: Vesikari
authors.affiliation: Department of Preventive Medicine, Poznan University of Medical Sciences, Poland.
authors.forename: Jacek
authors.initials: J
authors.lastname: Wysocki
authors.affiliation: Vaccine Research, Pfizer UK, Maidenhead, United Kingdom.
authors.forename: Johannes
authors.initials: J
authors.lastname: Beeslaar
authors.affiliation: Vaccine Research and Development, Pfizer, Pearl River, New York.
authors.forename: Joseph
authors.initials: J
authors.lastname: Eiden
authors.affiliation: Medical Development and Scientific Affairs.
authors.forename: Qin
authors.initials: Q
authors.lastname: Jiang
authors.affiliation: Vaccine Research and Development, Pfizer, Pearl River, New York.
authors.forename: Kathrin U
authors.initials: KU
authors.lastname: Jansen
authors.affiliation: Vaccine Research and Development, Pfizer, Pearl River, New York.
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Jones
authors.affiliation: Vaccine Research and Development, Pfizer, Pearl River, New York.
authors.forename: Shannon L
authors.initials: SL
authors.lastname: Harris
authors.affiliation: Vaccine Research and Development, Pfizer, Pearl River, New York.
authors.forename: Robert E
authors.initials: RE
authors.lastname: O'Neill
authors.affiliation: Medical Development and Scientific Affairs.
authors.forename: Laura J
authors.initials: LJ
authors.lastname: York
authors.affiliation: Vaccine Research, Pfizer, Collegeville, Pennsylvania.
authors.forename: John L
authors.initials: JL
authors.lastname: Perez
mesh_terms: D000293:Adolescent; D000907:Antibodies, Bacterial / Q000097:blood; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D000071497:Immunogenicity, Vaccine; D008297:Male; D022401:Meningococcal Vaccines / Q000008:administration & dosage* / Q000627:therapeutic use; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage* / Q000627:therapeutic use; D016037:Single-Blind Method; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000627:therapeutic use
chemical_list: D000907:Antibodies, Bacterial; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D022401:Meningococcal Vaccines; D011054:Poliovirus Vaccine, Inactivated; D017778:Vaccines, Combined
keywords: adolescents; diphtheria, tetanus, and acellular pertussis/inactivated poliovirus vaccine (DTaP/IPV); meningitis; rLP2086; vaccine