title: Immunogenicity and safety of concomitant administration of a combined hepatitis A/B vaccine and a quadrivalent meningococcal conjugate vaccine in healthy adults.
abstract: BACKGROUND
  This phase 3b randomized, open-label study evaluated the immunogenicity and safety of coadministration of a hepatitis A and/or B vaccine with a quadrivalent oligosaccharide meningococcal CRM197 -conjugate vaccine (MenACWY-CRM), in the context of an accelerated hepatitis A and/or B immunization schedule.
  
  
  METHODS
  A total of 252 healthy adult subjects were randomized to three groups to receive hepatitis A/B only (HepA/B), hepatitis A/B coadministered with MenACWY-CRM (HepA/B+MenACWY-CRM), or MenACWY-CRM only (MenACWY-CRM). Hepatitis A and/or B vaccination was administered in the form of a single booster dose or a primary three-dose series, depending on the hepatitis A and/or B vaccination history of subjects. Antibody responses to hepatitis A/B vaccination were assessed 1 month following the last hepatitis A and/or B dose. Serum bactericidal activity with human complement (hSBA) against meningococcal serogroups A, C, W-135, and Y was assessed 1 month post-MenACWY-CRM vaccination. Safety was monitored throughout the study.
  
  
  RESULTS
  At 1 month following the final hepatitis A and/or B vaccination, concomitant administration of hepatitis A/B and MenACWY-CRM was non-inferior to administration of hepatitis A/B alone in terms of geometric mean concentrations of antibodies against the hepatitis A and B antigens. One month post-MenACWY-CRM vaccination, the percentages of subjects achieving hSBA titers ≥8 for serogroups A, C, W-135, and Y in the HepA/B+MenACWY-CRM group (76, 87, 99, and 94%, respectively) were comparable to those in the MenACWY-CRM group (67, 82, 96, and 88%, respectively). The percentages of subjects reporting adverse events (AEs) were similar across study groups and a majority of the reported AEs were mild to moderate in nature. There were no study vaccine-related serious AEs.
  
  
  CONCLUSIONS
  MenACWY-CRM can be administered concomitantly with a hepatitis A and/or B vaccine in the context of an accelerated hepatitis A and/or B immunization schedule without increasing safety concerns or compromising the immune responses to any of the vaccine antigens. [NCT01453348].
authors.affiliation: Department of Infectious Diseases and Tropical Medicine, University of Munich, Munich, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Alberer
authors.forename: Gerd
authors.initials: G
authors.lastname: Burchard
authors.forename: Tomas
authors.initials: T
authors.lastname: Jelinek
authors.forename: Emil C
authors.initials: EC
authors.lastname: Reisinger
authors.forename: Seetha
authors.initials: S
authors.lastname: Meyer
authors.forename: Eduardo
authors.initials: E
authors.lastname: Forleo-Neto
authors.forename: Alemnew F
authors.initials: AF
authors.lastname: Dagnew
authors.forename: Ashwani Kumar
authors.initials: AK
authors.lastname: Arora
mesh_terms: D000293:Adolescent; D000328:Adult; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005858:Germany; D006506:Hepatitis A / Q000517:prevention & control; D022362:Hepatitis A Vaccines / Q000008:administration & dosage / Q000009:adverse effects; D006509:Hepatitis B / Q000517:prevention & control; D017325:Hepatitis B Vaccines / Q000008:administration & dosage; D006801:Humans; D007115:Immunization Schedule; D008297:Male; D008589:Meningococcal Infections / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D016896:Treatment Outcome; D018074:Vaccines, Conjugate / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult
chemical_list: D022362:Hepatitis A Vaccines; D017325:Hepatitis B Vaccines; C525703:MenACWY; D022401:Meningococcal Vaccines; D018074:Vaccines, Conjugate