PMID- 25692350
OWN - NLM
STAT- MEDLINE
DCOM- 20151215
LR  - 20231111
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 11
IP  - 2
DP  - 2015
TI  - Immunogenicity and safety of purified chick-embryo cell rabies vaccine under 
      Zagreb 2-1-1 or 5-dose Essen regimen in Chinese children 6 to 17 years old and 
      adults over 50 years: a randomized open-label study.
PG  - 435-42
LID - 10.4161/21645515.2014.994460 [doi]
AB  - The aim of this Phase IIIb, open-label, randomized study was to demonstrate the 
      non-inferiority of immune responses and to assess the safety of a purified 
      chick-embryo cell rabies vaccine (PCECV) in healthy Chinese children (6 to 
      17 years) and older adults (>/=51 years) following 2 alternative intramuscular (IM) 
      simulated post-exposure prophylaxis (PEP) regimens: 4-dose Zagreb or 5-dose Essen 
      regimen. Serum samples were collected prior to vaccination on Days 1 and 15 and 
      on day 43 to assess immune response by rabies virus neutralizing antibody (RVNA) 
      concentrations. Solicited adverse events (AEs) were recorded for up to 7 days 
      following each vaccine dose, and unsolicited AEs throughout the entire study 
      period. PCECV vaccination induced a strong immune response at Day 15, and the 
      non-inferiority in immune response of the Zagreb vs. the Essen regimen was 
      demonstrated in children and older adults. At Day 15,100% of children (N = 224), 
      and 99% of subjects >/=51 years of age (N = 376) developed adequate RVNA 
      concentrations (>/=0.5 IU/mL); at Day 43 all subjects achieved RVNA concentrations 
      >/=0.5 IU/mL, for both PEP regimens. The well-known tolerability and safety profile 
      of the PCECV was again observed in this study following either Zagreb or Essen 
      regimens. Rabies PEP vaccination with PCECV following a Zagreb regimen induced 
      immune responses non-inferior to those of the Essen regimen, and had a similar 
      safety and tolerability profile to the Essen regimen in Chinese children, 
      adolescents, and adults over 51 years. ClinicalTrials.gov identifier: 
      NCT01680016.
FAU - Li, RongCheng
AU  - Li R
AD  - a Guangxi Center for Disease Prevention and Control ; Guangxi , China.
FAU - Li, YanPing
AU  - Li Y
FAU - Wen, ShuQing
AU  - Wen S
FAU - Wen, HuiChun
AU  - Wen H
FAU - Nong, Yi
AU  - Nong Y
FAU - Mo, Zhaojun
AU  - Mo Z
FAU - Xie, Fang
AU  - Xie F
FAU - Pellegrini, Michele
AU  - Pellegrini M
LA  - eng
SI  - ClinicalTrials.gov/NCT01680016
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Neutralizing)
RN  - 0 (Antibodies, Viral)
RN  - 0 (Rabies Vaccines)
SB  - IM
MH  - Adolescent
MH  - Aged
MH  - Aged, 80 and over
MH  - Animals
MH  - Antibodies, Neutralizing/*blood
MH  - Antibodies, Viral/*blood
MH  - Chick Embryo
MH  - Child
MH  - China
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology/pathology
MH  - Female
MH  - Humans
MH  - Injections, Intramuscular
MH  - Male
MH  - Middle Aged
MH  - Post-Exposure Prophylaxis/*methods
MH  - Rabies/*prevention & control
MH  - Rabies Vaccines/administration & dosage/*adverse effects/*immunology/isolation & 
      purification
MH  - Time Factors
MH  - Vaccination/*methods
PMC - PMC4514244
OTO - NOTNLM
OT  - AE, adverse event
OT  - CI, confidence interval
OT  - Essen regimen
OT  - GMC, geometric mean concentration
OT  - IM, intramuscular
OT  - NIFDC, National Institutes for Food and Drug Control
OT  - PCECV, purified chick-embryo cell rabies vaccine
OT  - PEP, post-exposure prophylaxis
OT  - PPS, per-protocol set
OT  - RFFIT, Rapid Fluorescent Focus Inhibition Test
OT  - RVNA, rabies virus neutralizing antibody
OT  - Zagreb regimen
OT  - immunogenicity
OT  - intramuscular post-exposure prophylaxis; purified chick-embryo cell rabies 
      vaccine
OT  - rabies
OT  - rabies virus neutralizing antibody
EDAT- 2015/02/19 06:00
MHDA- 2015/12/17 06:00
PMCR- 2016/02/18
CRDT- 2015/02/19 06:00
PHST- 2015/02/19 06:00 [entrez]
PHST- 2015/02/19 06:00 [pubmed]
PHST- 2015/12/17 06:00 [medline]
PHST- 2016/02/18 00:00 [pmc-release]
AID - 994460 [pii]
AID - 10.4161/21645515.2014.994460 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2015;11(2):435-42. doi: 10.4161/21645515.2014.994460.