PMID- 29553862
OWN - NLM
STAT- MEDLINE
DCOM- 20190424
LR  - 20240329
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 14
IP  - 7
DP  - 2018 Jul 3
TI  - Immunogenicity, safety, and tolerability of a recombinant hepatitis B vaccine 
      manufactured by a modified process in healthy young Japanese adults.
PG  - 1773-1778
LID - 10.1080/21645515.2018.1452578 [doi]
AB  - Hepatitis B vaccines are highly effective in preventing hepatitis B virus 
      infection and have been included in the national immunization program of Japan 
      since 2016. Heptavax(R)-II is one of two hepatitis B vaccine products licensed in 
      Japan, and its manufacturing process is being modified to reduce variability of 
      manufacturing and optimize immunogenicity. In this study (NCT01463683), the 
      immunogenicity and safety of a modified-process hepatitis B vaccine (mpHBV) were 
      compared to those of the licensed Heptavax(R)-II. Overall, 722 Japanese adults aged 
      20-to-35 years old were randomized in a 3:3:1 ratio to either the mpHBV 
      subcutaneous (SC) injection group (mpHBV SC), the Heptavax(R)-II SC injection group 
      (Heptavax(R)-II SC), or the mpHBV intramuscular (IM) injection group (mpHBV IM). 
      All participants received a 3-dose series of either mpHBV or Heptavax(R)-II at Day 
      1, Month 1, and Month 6. Serum antibody to hepatitis B virus surface antigen 
      (anti-HBs) was assayed on Day 1 prior to the first vaccination and Month 7 (1 
      month Postdose 3). Seroprotection rates in mpHBV SC were non-inferior to that in 
      Heptavax(R)-II SC and anti-HBs geometric mean titers were numerically higher in 
      mpHBV SC as compared to Heptavax(R)-II SC. The incidences of injection-site and 
      systemic adverse events (AEs) observed in mpHBV SC were comparable to those in 
      Heptavax(R)-II SC, except for erythema which was higher in mpHBV SC than in 
      Heptavax(R)-II SC. Most injection-site and systemic AEs were mild-to-moderate in 
      intensity and there were no reports of vaccine-related serious AEs in any group. 
      IM administration of mpHBV was well-tolerated and more immunogenic compared to SC 
      administration. In conclusion, mpHBV and Heptavax(R)-II were well-tolerated and 
      elicited satisfactory immune responses for the prevention against hepatitis B 
      virus-associated diseases.
FAU - Kishino, Hiroyuki
AU  - Kishino H
AD  - a Japan Development, MSD K.K. , Tokyo , Japan.
FAU - Takahashi, Kenichi
AU  - Takahashi K
AD  - a Japan Development, MSD K.K. , Tokyo , Japan.
FAU - Sawata, Miyuki
AU  - Sawata M
AD  - a Japan Development, MSD K.K. , Tokyo , Japan.
FAU - Tanaka, Yoshiyuki
AU  - Tanaka Y
AD  - a Japan Development, MSD K.K. , Tokyo , Japan.
LA  - eng
SI  - ClinicalTrials.gov/NCT01463683
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20180412
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Hepatitis B Antibodies)
RN  - 0 (Hepatitis B Surface Antigens)
RN  - 0 (Hepatitis B Vaccines)
SB  - IM
MH  - Adult
MH  - Female
MH  - Hepatitis B/prevention & control
MH  - Hepatitis B Antibodies/blood
MH  - Hepatitis B Surface Antigens/immunology
MH  - Hepatitis B Vaccines/administration & dosage/*immunology
MH  - Humans
MH  - *Immunogenicity, Vaccine
MH  - Injections, Intramuscular
MH  - Injections, Subcutaneous
MH  - Japan
MH  - Male
MH  - Young Adult
PMC - PMC6067840
OTO - NOTNLM
OT  - Japan
OT  - hepatitis B vaccine
OT  - immunogenicity
OT  - safety
OT  - subcutaneous administration
EDAT- 2018/03/20 06:00
MHDA- 2019/04/25 06:00
PMCR- 2018/04/12
CRDT- 2018/03/20 06:00
PHST- 2018/03/20 06:00 [pubmed]
PHST- 2019/04/25 06:00 [medline]
PHST- 2018/03/20 06:00 [entrez]
PHST- 2018/04/12 00:00 [pmc-release]
AID - 1452578 [pii]
AID - 10.1080/21645515.2018.1452578 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2018 Jul 3;14(7):1773-1778. doi: 
      10.1080/21645515.2018.1452578. Epub 2018 Apr 12.