title: Immunogenicity, safety and antibody persistence of a purified vero cell cultured rabies vaccine (Speeda) administered by the Zagreb regimen or Essen regimen in post-exposure subjects.
abstract: To compare the safety, immunogenicity and long-term effect of a purified vero cell cultured rabies vaccine in post-exposure subjects following 2 intramuscular regimens, Zagreb or Essen regimen.
  
  
  
  Serum samples were collected before vaccination and on days 7, 14, 42, 180 and 365 post vaccination. Solicited adverse events were recorded for 7 d following each vaccine dose, and unsolicited adverse events throughout the entire study period. This study was registered with ClinicalTrials.gov (NCT01821911 and NCT01827917).
  
  
  
  No serious adverse events were reported. Although Zagreb regimen had a higher incidence of adverse reactions than Essen regimen at the first and second injection, the incidence was similar at the third and fourth injection between these 2 groups as well. At day 42, 100% subjects developed adequate rabies virus neutralizing antibody concentrations (≥ 0.5IU/ml) for both regimens. At days 180 and 365, the antibody level decreased dramatically, however, the percentage of subjects with adequate antibody concentrations still remained high (above 75% and 50% respectively). None of confirmed rabies virus exposured subjects had rabies one year later, and percentage of subjects with adequate antibody concentrations reached 100% at days 14 and 42.
  
  
  
  Rabies post-exposure prophylaxis vaccination with PVRV following a Zagreb regimen had a similar safety, immunogenicity and long-term effect to the Essen regimen in China.
authors.affiliation: a Chaoyang District Center for Disease Control and Prevention , Beijing , P.R. China.
authors.forename: Nianmin
authors.initials: N
authors.lastname: Shi
authors.affiliation: b Liaoning Chengda biological Limited by Share Ltd , Shenyang , P.R. China.
authors.forename: Yibin
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: c Guangdong Provincial Center for Disease Control and Prevention , Guangzhou , P.R. China.
authors.forename: Huizhen
authors.initials: H
authors.lastname: Zheng
authors.affiliation: d Wuhan City Center for Disease Control and Prevention , Wuhan , P.R. China.
authors.forename: Zhenggang
authors.initials: Z
authors.lastname: Zhu
authors.affiliation: e Guizhou Provincial Center for Disease Control and Prevention , Guiyang , P.R. China.
authors.forename: Dingming
authors.initials: D
authors.lastname: Wang
authors.affiliation: f Hunan Provincial Center for Disease Control and Prevention , Changsha , P.R. China.
authors.forename: Sihai
authors.initials: S
authors.lastname: Li
authors.affiliation: g National Institutes for Food and Drug Control , Beijing , P.R. China.
authors.forename: Yuhua
authors.initials: Y
authors.lastname: Li
authors.affiliation: a Chaoyang District Center for Disease Control and Prevention , Beijing , P.R. China.
authors.forename: Liqing
authors.initials: L
authors.lastname: Yang
authors.affiliation: a Chaoyang District Center for Disease Control and Prevention , Beijing , P.R. China.
authors.forename: Junnan
authors.initials: J
authors.lastname: Zhang
authors.affiliation: a Chaoyang District Center for Disease Control and Prevention , Beijing , P.R. China.
authors.forename: Yunhua
authors.initials: Y
authors.lastname: Bai
authors.affiliation: a Chaoyang District Center for Disease Control and Prevention , Beijing , P.R. China.
authors.forename: Qiang
authors.initials: Q
authors.lastname: Lu
authors.affiliation: a Chaoyang District Center for Disease Control and Prevention , Beijing , P.R. China.
authors.forename: Zheng
authors.initials: Z
authors.lastname: Zhang
authors.affiliation: a Chaoyang District Center for Disease Control and Prevention , Beijing , P.R. China.
authors.forename: Fengji
authors.initials: F
authors.lastname: Luo
authors.affiliation: e Guizhou Provincial Center for Disease Control and Prevention , Guiyang , P.R. China.
authors.forename: Chun
authors.initials: C
authors.lastname: Yu
authors.affiliation: a Chaoyang District Center for Disease Control and Prevention , Beijing , P.R. China.
authors.forename: Li
authors.initials: L
authors.lastname: Li
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D000914:Antibodies, Viral / Q000097:blood*; D002648:Child; D002675:Child, Preschool; D004285:Dogs; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D007231:Infant, Newborn; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D056990:Post-Exposure Prophylaxis / Q000379:methods*; D011818:Rabies / Q000517:prevention & control*; D011819:Rabies Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D013678:Technology, Pharmaceutical; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D011819:Rabies Vaccines
keywords: Immunogenicity; Post-exposure; Protective effect; Rabies vaccine; Safety