PMID- 25969894
OWN - NLM
STAT- MEDLINE
DCOM- 20160311
LR  - 20181113
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 11
IP  - 6
DP  - 2015
TI  - Immunogenicity and safety of investigational vaccine formulations against 
      meningococcal serogroups A, B, C, W, and Y in healthy adolescents.
PG  - 1507-17
LID - 10.1080/21645515.2015.1029686 [doi]
AB  - This phase 2 study assessed the immunogenicity, safety, and reactogenicity of 
      investigational formulations of meningococcal ABCWY vaccines, consisting of 
      recombinant proteins (rMenB) and outer membrane vesicle (OMV) components of a 
      licensed serogroup B vaccine, combined with components of a licensed quadrivalent 
      meningococcal glycoconjugate vaccine (MenACWY-CRM). A total of 495 healthy 
      adolescents were randomized to 6 groups to receive 2 doses (Months 0, 2) of one 
      of 4 formulations of rMenB antigens, with or without OMV, combined with 
      MenACWY-CRM, or 2 doses of rMenB alone or one dose of MenACWY-CRM then a placebo. 
      Immunogenicity was assessed by serum bactericidal assay with human complement 
      (hSBA) against serogroups ACWY and serogroup B test strains; solicited reactions 
      and any adverse events (AEs) were assessed. Two MenABCWY vaccinations elicited 
      robust ACWY immune responses, with higher seroresponse rates than one dose of 
      MenACWY-CRM. Bactericidal antibody responses against the rMenB antigens and OMV 
      components were highest in subjects who received 2 doses of OMV-containing 
      MenABCWY formulations, with >/=68% of subjects achieving hSBA titers >/=5 against 
      each of the serogroup B test strains. After the first dose, solicited local 
      reaction rates were higher in the MenABCWY or rMenB groups than the MenACWY-CRM 
      group, but similar across groups after the second dose, consisting mainly of 
      transient injection site pain. Fever (>/=38.0 degrees C) was rare and there were no 
      vaccine-related serious AEs. In conclusion, investigational MenABCWY formulations 
      containing OMV components elicited highly immunogenic responses against 
      meningococcal serogroups ACWY, as well as serogroup B test strains, with an 
      acceptable safety profile. [NCT01210885].
FAU - Saez-Llorens, Xavier
AU  - Saez-Llorens X
AD  - a Infectious Disease Department; Hospital del Nino ; Panama City , Panama.
FAU - Aguilera Vaca, Diana Catalina
AU  - Aguilera Vaca DC
FAU - Abarca, Katia
AU  - Abarca K
FAU - Maho, Emmanuelle
AU  - Maho E
FAU - Grana, Maria Gabriela
AU  - Grana MG
FAU - Heijnen, Esther
AU  - Heijnen E
FAU - Smolenov, Igor
AU  - Smolenov I
FAU - Dull, Peter M
AU  - Dull PM
LA  - eng
SI  - ClinicalTrials.gov/NCT01210885
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Drugs, Investigational)
RN  - 0 (Meningococcal Vaccines)
RN  - 0 (Placebos)
RN  - 0 (Vaccines, Combined)
SB  - IM
MH  - Adolescent
MH  - Blood Bactericidal Activity
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology/pathology
MH  - Drugs, Investigational/administration & dosage/*adverse effects
MH  - Female
MH  - Healthy Volunteers
MH  - Humans
MH  - Male
MH  - Meningococcal Vaccines/administration & dosage/*adverse effects/*immunology
MH  - Placebos/administration & dosage
MH  - Vaccines, Combined/administration & dosage/adverse effects/immunology
PMC - PMC4514249
OTO - NOTNLM
OT  - AE, adverse event
OT  - CI, confidence interval
OT  - GMT, geometric mean titer
OT  - IMD, invasive meningococcal disease
OT  - NHBA, Neisserial Heparin Binding Antigen
OT  - NadA, Neisseria adhesin A
OT  - Neisseria meningitidis
OT  - OMV, outer membrane vesicle
OT  - PP, per-protocol set
OT  - SAE, serious adverse event
OT  - adolescents
OT  - conjugate vaccine
OT  - fHbp, factor H-binding protein
OT  - hSBA, serum bactericidal assay with human complement
OT  - immunogenicity
OT  - meningococcal disease
OT  - safety
EDAT- 2015/05/15 06:00
MHDA- 2016/03/12 06:00
PMCR- 2016/05/13
CRDT- 2015/05/14 06:00
PHST- 2015/05/14 06:00 [entrez]
PHST- 2015/05/15 06:00 [pubmed]
PHST- 2016/03/12 06:00 [medline]
PHST- 2016/05/13 00:00 [pmc-release]
AID - 1029686 [pii]
AID - 10.1080/21645515.2015.1029686 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2015;11(6):1507-17. doi: 10.1080/21645515.2015.1029686.