PMID- 32233961
OWN - NLM
STAT- MEDLINE
DCOM- 20210621
LR  - 20240330
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 16
IP  - 6
DP  - 2020 Jun 2
TI  - Immunogenicity and safety of a quadrivalent meningococcal tetanus 
      toxoid-conjugate vaccine (MenACYW-TT) in adults 56 years of age and older: a 
      Phase II randomized study.
PG  - 1299-1305
LID - 10.1080/21645515.2020.1733868 [doi]
AB  - MenACYW-TT is an investigational quadrivalent meningococcal conjugate vaccine 
      intended for the prevention of invasive meningococcal disease (IMD) caused by 
      serogroups A, C, W, and Y in individuals aged 6 weeks and above. This Phase II, 
      randomized, open-label, multicenter, exploratory study assessed the safety and 
      immunogenicity of MenACYW-TT compared with a quadrivalent meningococcal 
      polysaccharide vaccine (MPSV4) in 301 healthy adults aged >/=56 y in the US 
      (NCT01732627). Participants were randomized 2:1 to receive MenACYW-TT or MPSV4. 
      Serum bactericidal assays using human (hSBA) or baby rabbit (rSBA) complement 
      were used to measure functional antibodies against meningococcal serogroups A, C, 
      W, and Y at baseline and 30 d post-vaccination. Safety data were collected up to 
      30 d post-vaccination. Proportions of study participants with hSBA titers >/=1:8 
      against serogroups A, C, W, and Y were increased at Day 30 compared with baseline 
      in both vaccine groups. The proportions of participants with hSBA titers >/=1:8 
      after MenACYW-TT vaccination were comparable to those after MPSV4 vaccination for 
      serogroups A and C (A: 93.8% vs. 85.1%; C: 74.9% vs. 62.8%) and distinctly higher 
      than after MPSV4 for serogroups W and Y (W: 79.5% vs. 60.6%; Y: 80.5% vs. 59.6%). 
      Proportions of participants with rSBA titers >/=1:8 were comparable between vaccine 
      groups for all four serogroups. The reactogenicity profiles of both vaccines were 
      similar. Most unsolicited adverse events (AEs) were of Grade 1 or Grade 2 
      intensity, and no serious AEs were reported. The MenACYW-TT conjugate vaccine was 
      well tolerated and immunogenic in adults aged >/=56 y.
FAU - Kirstein, Judith
AU  - Kirstein J
AUID- ORCID: 0000-0001-9665-8525
AD  - Advanced Clinical Research , West Jordan, UT, USA.
FAU - Pina, Miriam
AU  - Pina M
AD  - Clinical Development, Sanofi Pasteur , Swiftwater, PA, USA.
FAU - Pan, Judy
AU  - Pan J
AD  - Clinical Development, Sanofi Pasteur , Swiftwater, PA, USA.
FAU - Jordanov, Emilia
AU  - Jordanov E
AD  - Clinical Development, Sanofi Pasteur , Swiftwater, PA, USA.
FAU - Dhingra, Mandeep S
AU  - Dhingra MS
AUID- ORCID: 0000-0002-2507-7165
AD  - Clinical Development, Sanofi Pasteur , Swiftwater, PA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01732627
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20200401
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Meningococcal Vaccines)
RN  - 0 (Tetanus Toxoid)
RN  - 0 (Vaccines, Conjugate)
SB  - IM
MH  - Antibodies, Bacterial
MH  - Female
MH  - Humans
MH  - Male
MH  - *Meningococcal Infections/prevention & control
MH  - *Meningococcal Vaccines/immunology
MH  - Middle Aged
MH  - Tetanus Toxoid
MH  - Vaccines, Conjugate/immunology
PMC - PMC7482642
OTO - NOTNLM
OT  - MPSV4
OT  - MenACYW-TT
OT  - invasive meningococcal disease
OT  - older adults
OT  - vaccine
EDAT- 2020/04/03 06:00
MHDA- 2021/06/22 06:00
PMCR- 2020/04/01
CRDT- 2020/04/03 06:00
PHST- 2020/04/03 06:00 [pubmed]
PHST- 2021/06/22 06:00 [medline]
PHST- 2020/04/03 06:00 [entrez]
PHST- 2020/04/01 00:00 [pmc-release]
AID - 1733868 [pii]
AID - 10.1080/21645515.2020.1733868 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2020 Jun 2;16(6):1299-1305. doi: 
      10.1080/21645515.2020.1733868. Epub 2020 Apr 1.