PMID- 33132297
OWN - NLM
STAT- MEDLINE
DCOM- 20210823
LR  - 20210823
IS  - 1884-2836 (Electronic)
IS  - 1344-6304 (Linking)
VI  - 74
IP  - 3
DP  - 2021 May 24
TI  - Immunogenicity and Safety of a Two-Dose Series of a Meningococcal (Groups A, C, 
      W, and Y) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Men-ACWY-D) in 
      Healthy Japanese Adults.
PG  - 193-199
LID - 10.7883/yoken.JJID.2020.411 [doi]
AB  - The quadrivalent meningococcal polysaccharide diphtheria toxoid conjugate vaccine 
      (Men-ACWY-D) has been licensed for use in Japan since 2014. An earlier 
      registration study demonstrated the immunogenicity of a single dose in Japanese 
      adults, wherein the immunogenicity against serogroup C was the lowest. The 
      determination of the potential to increase the serogroup C response with a second 
      dose was, therefore, of interest. This study (NCT02591290) evaluated the safety 
      and immunogenicity of two doses administered 8 weeks apart to 60 healthy Japanese 
      adults aged 20-55 years. Blood samples were collected at 28-35 days after 
      vaccination. Immunogenicity endpoints included seroprotection and seroconversion 
      rates. Safety assessments included systemic adverse events (AEs), non-serious 
      AEs, and serious AEs. Fifty-eight participants (96.7%) completed the study. The 
      seroprotection rates for serogroups A, C, W, and Y before vaccination were 76.8%, 
      26.8%, 26.8%, and 50.0%, respectively, increasing to 100%, 83.9%, 91.1%, and 
      96.4% and 100%, 92.9%, 94.6%, and 94.6%, respectively, after two doses. The 
      seroconversion rates for the four serogroups were 100%, 93.8%, 97.1%, and 94.1%, 
      respectively, after the first dose, and 100%, 96.9%, 100%, and 100%, 
      respectively, after the second. The increase between the doses was insignificant, 
      and there were no safety concerns. The two-dose series was well tolerated; 
      however, the clinical benefits of a second dose within 8 weeks seemed to be low.
FAU - Matsuoka, Osamu
AU  - Matsuoka O
AD  - Medical Corporation Heishinkai ToCROM Clinic, Japan.
FAU - Tsuzuki, Daisuke
AU  - Tsuzuki D
AD  - Sanofi K. K., Japan.
FAU - Suzuki, Katsuhisa
AU  - Suzuki K
AD  - Sanofi K. K., Japan.
FAU - Tanaka, Tomoyuki
AU  - Tanaka T
AD  - Sanofi K. K., Japan.
FAU - Takagi, Yoshiharu
AU  - Takagi Y
AD  - Sanofi K. K., Japan.
FAU - Oster, Philipp
AU  - Oster P
AD  - Sanofi Pasteur, France.
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
DEP - 20201030
PL  - Japan
TA  - Jpn J Infect Dis
JT  - Japanese journal of infectious diseases
JID - 100893704
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Diphtheria Toxoid)
RN  - 0 (Meningococcal Vaccines)
RN  - 0 (Vaccines, Conjugate)
SB  - IM
MH  - Adult
MH  - Antibodies, Bacterial/blood
MH  - Diphtheria Toxoid
MH  - Female
MH  - Humans
MH  - Immunization Schedule
MH  - Japan
MH  - Male
MH  - Meningitis, Meningococcal/prevention & control
MH  - Meningococcal Vaccines/blood/*immunology/*pharmacology
MH  - Middle Aged
MH  - Serogroup
MH  - Vaccines, Conjugate/pharmacology
MH  - Young Adult
OTO - NOTNLM
OT  - Japan
OT  - Men-ACWY-D
OT  - immunogenicity
OT  - meningococcal conjugate vaccine
OT  - safety
EDAT- 2020/11/03 06:00
MHDA- 2021/08/24 06:00
CRDT- 2020/11/02 06:11
PHST- 2020/11/03 06:00 [pubmed]
PHST- 2021/08/24 06:00 [medline]
PHST- 2020/11/02 06:11 [entrez]
AID - 10.7883/yoken.JJID.2020.411 [doi]
PST - ppublish
SO  - Jpn J Infect Dis. 2021 May 24;74(3):193-199. doi: 10.7883/yoken.JJID.2020.411. 
      Epub 2020 Oct 30.