PMID- 22832260
OWN - NLM
STAT- MEDLINE
DCOM- 20130312
LR  - 20141009
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Linking)
VI  - 8
IP  - 7
DP  - 2012 Jul
TI  - A phase 1, randomized, open-label, active-controlled trial to assess the safety 
      of a meningococcal serogroup B bivalent rLP2086 vaccine in healthy adults.
PG  - 888-95
LID - 10.4161/hv.19983 [doi]
AB  - Neisseria meningitidis serogroup B (MnB) is a significant cause of invasive 
      meningococcal disease, but no broadly protective vaccine is yet approved. We 
      assessed the safety and immunogenicity of a bivalent MnB vaccine composed of 
      lipidated subfamily A and B variants of recombinant LP2086 (rLP2086, also known 
      as factor H binding protein, fHBP). Forty-eight adults, ages 18-40 y, were 
      randomized to receive 60, 120 or 200 mug of the bivalent rLP2086 vaccine or 
      control at 0, 2 and 6 mo. Immunogenicity was assessed by rLP2086-specific 
      immunoglobulin G (IgG) geometric mean titers for subfamily A and B proteins. 
      Safety was determined by laboratory assessments of blood and urine and by 
      reporting of solicited and unsolicited adverse events (AEs). The bivalent rLP2086 
      vaccine elicited high IgG titers following the second and third vaccination at 
      all dose levels. In each of the four study arms, 11 of the 12 participating 
      subjects reported >/= 1 AE, and no serious AEs were reported. Local and systemic 
      reactions were mainly mild to moderate. Laboratory abnormalities (including 
      increased sodium, decreased neutrophils, and proteinuria) were not associated 
      with clinical events and were not considered to be related to the study vaccine. 
      Vaccinations were generally well-tolerated. Strong IgG antibody responses and the 
      absence of clinically significant laboratory abnormalities support further 
      development of the bivalent rLP2086 vaccine (www.clinicaltrials.gov; identifier: 
      NCT00879814).
FAU - Sheldon, Eric A
AU  - Sheldon EA
AD  - Miami Research Associates, Miami, FL, USA. esheldon@miamiresearch.com
FAU - Schwartz, Howard
AU  - Schwartz H
FAU - Jiang, Qin
AU  - Jiang Q
FAU - Giardina, Peter C
AU  - Giardina PC
FAU - Perez, John L
AU  - Perez JL
LA  - eng
SI  - ClinicalTrials.gov/NCT00879814
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120701
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Antigens, Bacterial)
RN  - 0 (Bacterial Proteins)
RN  - 0 (Immunoglobulin G)
RN  - 0 (Meningococcal Vaccines)
RN  - 0 (factor H-binding protein, Neisseria meningitidis)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antibodies, Bacterial/blood
MH  - Antigens, Bacterial/*immunology
MH  - Bacterial Proteins/*immunology
MH  - Blood Chemical Analysis
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Female
MH  - Humans
MH  - Immunoglobulin G/blood
MH  - Male
MH  - Meningococcal Vaccines/administration & dosage/*adverse effects/*immunology
MH  - Neisseria meningitidis, Serogroup B/*immunology
MH  - Urine/chemistry
MH  - Young Adult
EDAT- 2012/07/27 06:00
MHDA- 2013/03/13 06:00
CRDT- 2012/07/27 06:00
PHST- 2012/07/27 06:00 [entrez]
PHST- 2012/07/27 06:00 [pubmed]
PHST- 2013/03/13 06:00 [medline]
AID - 19983 [pii]
AID - 10.4161/hv.19983 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2012 Jul;8(7):888-95. doi: 10.4161/hv.19983. Epub 2012 Jul 
      1.