PMID- 23885033
OWN - NLM
STAT- MEDLINE
DCOM- 20140421
LR  - 20211021
IS  - 1556-679X (Electronic)
IS  - 1556-6811 (Print)
IS  - 1556-679X (Linking)
VI  - 20
IP  - 10
DP  - 2013 Oct
TI  - Meningococcal polysaccharide A O-acetylation levels do not impact the 
      immunogenicity of the quadrivalent meningococcal tetanus toxoid conjugate 
      vaccine: results from a randomized, controlled phase III study of healthy adults 
      aged 18 to 25 years.
PG  - 1499-507
LID - 10.1128/CVI.00162-13 [doi]
AB  - In this study, we compared the immunogenicities of two lots of meningococcal 
      ACWY-tetanus toxoid conjugate vaccine (MenACWY-TT) that differed in serogroup A 
      polysaccharide (PS) O-acetylation levels and evaluated their immunogenicities and 
      safety in comparison to a licensed ACWY polysaccharide vaccine (Men-PS). In this 
      phase III, partially blinded, controlled study, 1,170 healthy subjects aged 18 to 
      25 years were randomized (1:1:1) to receive one dose of MenACWY-TT lot A (ACWY-A) 
      (68% O-acetylation), MenACWY-TT lot B (ACWY-B) (92% O-acetylation), or Men-PS 
      (82% O-acetylation). Immunogenicity was evaluated in terms of serum bactericidal 
      activity using rabbit complement (i.e., rabbit serum bactericidal activity 
      [rSBA]). Solicited symptoms, unsolicited adverse events (AEs), and serious AEs 
      (SAEs) were recorded. The immunogenicities, in terms of rSBA geometric mean 
      titers, were comparable for both lots of MenACWY-TT. The vaccine response rates 
      across the serogroups were 79.1 to 97.0% in the two ACWY groups and 73.7 to 94.1% 
      in the Men-PS group. All subjects achieved rSBA titers of >/=1:8 for all 
      serogroups. All subjects in the two ACWY groups and 99.5 to 100% in the Men-PS 
      group achieved rSBA titers of >/=1:128. Pain was the most common solicited local 
      symptom and was reported more frequently in the ACWY group (53.9 to 54.7%) than 
      in the Men-PS group (36.8%). The most common solicited general symptoms were 
      fatigue and headache, which were reported by 28.6 to 30.3% and 26.9 to 31.0% of 
      subjects, respectively. Two subjects reported SAEs; one SAE was considered to be 
      related to vaccination (blighted ovum; ACWY-B group). The level of serogroup A PS 
      O-acetylation did not affect vaccine immunogenicity. MenACWY-TT (lot A) was not 
      inferior to Men-PS in terms of vaccine response and was well tolerated.
FAU - Lupisan, Socorro
AU  - Lupisan S
AD  - Research Institute for Tropical Medicine, Department of Health, Muntinlupa City, 
      Philippines.
FAU - Limkittikul, Kriengsak
AU  - Limkittikul K
FAU - Sosa, Nestor
AU  - Sosa N
FAU - Chanthavanich, Pornthep
AU  - Chanthavanich P
FAU - Bianco, Veronique
AU  - Bianco V
FAU - Baine, Yaela
AU  - Baine Y
FAU - Van der Wielen, Marie
AU  - Van der Wielen M
FAU - Miller, Jacqueline M
AU  - Miller JM
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130724
PL  - United States
TA  - Clin Vaccine Immunol
JT  - Clinical and vaccine immunology : CVI
JID - 101252125
RN  - 0 (Meningococcal Vaccines)
RN  - 0 (Polysaccharides, Bacterial)
RN  - 0 (Vaccines, Conjugate)
RN  - 0 (meningococcal group A polysaccharide)
RN  - 0 (tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid 
      conjugate vaccine)
SB  - IM
MH  - Acetylation
MH  - Adolescent
MH  - Adult
MH  - *Blood Bactericidal Activity
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology/pathology
MH  - Fatigue/epidemiology
MH  - Female
MH  - Headache/epidemiology
MH  - Healthy Volunteers
MH  - Humans
MH  - Male
MH  - Meningococcal Vaccines/administration & dosage/*adverse effects/*immunology
MH  - Pain/epidemiology
MH  - Polysaccharides, Bacterial/*immunology/*metabolism
MH  - Vaccines, Conjugate/administration & dosage/adverse effects/immunology
MH  - Young Adult
PMC - PMC3807210
EDAT- 2013/07/26 06:00
MHDA- 2014/04/22 06:00
PMCR- 2013/10/01
CRDT- 2013/07/26 06:00
PHST- 2013/07/26 06:00 [entrez]
PHST- 2013/07/26 06:00 [pubmed]
PHST- 2014/04/22 06:00 [medline]
PHST- 2013/10/01 00:00 [pmc-release]
AID - CVI.00162-13 [pii]
AID - 00162-13 [pii]
AID - 10.1128/CVI.00162-13 [doi]
PST - ppublish
SO  - Clin Vaccine Immunol. 2013 Oct;20(10):1499-507. doi: 10.1128/CVI.00162-13. Epub 
      2013 Jul 24.