PMID- 28045585
OWN - NLM
STAT- MEDLINE
DCOM- 20171023
LR  - 20191210
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 13
IP  - 1
DP  - 2017 Jan 2
TI  - Immunogenicity and safety of purified vero cell rabies vaccine (PVRV) produced by 
      Liaoning Cheng Da Co. under Zagreb 2-1-1 or 5-dose Essen regimen in Chinese 
      adults aged 50 and above.
PG  - 144-150
LID - 10.1080/21645515.2016.1230260 [doi]
AB  - BACKGROUND: Two kinds of regimens (2-1-1 and 1-1-1-1-1) can be selected after 
      Zagreb regimen(2-1-1)of PVRV was officially approved in Beijing in January 2015. 
      Up to now, the subjects for most studies about the comparison between Zagreb and 
      Essen regimen are under 50 y old, rarely at and above. Aging of the immune system 
      may result in decreasing efficacy of vaccination, especially for adults aged 
      above 65-70 y. This study compared the safety and immunogenicity of the Zagreb 
      and Essen regimen in Chinese adults aged 50 and above with the goal to provide a 
      supplemental data for this age group. METHODS: A total of 114 cases were divided 
      into 2 groups randomly, received PVRV under the Zagreb and Essen regimens 
      respectively. Serum samples were collected at D0, D7, D14, D42, D180 and D365 to 
      determine the rabies serum neutralizing antibody by rapid fluorescent focus 
      inhibition test (RFFIT). Safety analyses were made by comparing the AEs in day-3, 
      day-7, and day-(7 + 21) in Zagreb or day-(7 + 28) in Essen by gender and age 
      cohorts. RESULTS: 617 blood samples were obtained. Two groups showed similar 
      immunogenicity, the neutralizing antibody titer of all subjects at D14 and D42 
      showed >0.5 IU/ml. Under the same regimen, Subjects >/=65 y had lower GMC than 
      those who <65 years from D7 to D365 within 2 groups. This difference was 
      significantly shown on D7, D14, D180 in Zagreb group, and on D180 in Essen group 
      (t = 2.38, p = 0.02; t = 3.78, p < 0.001; t = 2.30, p = 0.03; t = 4.42, p < 
      0.001). Subjects<65 years had higher seroconversion rate compared to >/=65 y on D7, 
      D180 and D365 in both 2 groups, this difference was also significantly shown on 
      D180, D365 in Zagreb group and on D180 in Essen group (chi(2) = 20.66, p < 0.001; 
      chi(2) = 6.56, p = 0.02; chi(2) = 10.96, p = 0.002). Two regimens all showed 
      favorable performances with mildly or common adverse events (AEs). The incidence 
      of local AEs after 3 d in Essen group was higher than Zagreb group (chi(2) = 9.69, 
      p = 0.002). The most common local AE was pain, the incidences (8.8%) in Zagreb 
      group was higher than Essen group (8.4%, chi(2) = 5.12, p = 0.02). All AEs for 
      Zagreb group and 52.3% of AEs for Essen group occurred during the first 72 hours. 
      During the first 72 hours, subjects aged <65 in Zagreb group (16.26%) had higher 
      incidences of AEs than Essen group (8.57%, chi(2) = 4.54, p = 0.03), males in 
      Zagreb group (16.05%) had higher incidence of AEs than Essen group (5.71%, chi(2) = 
      5.34, p = 0.02). The incidences of AEs close in during the first 7 d. CONCLUSION: 
      The Zagreb and Essen regimens demonstrated the similar safety and efficacy of 
      PVRV in Chinese adults aged 50 and above. People >/=65 y showed reduced immune 
      response to both regimens. More AEs for the Zagreb regimen were observed within 
      the first 72 hours, especially for male and people < 65 y.
FAU - Wang, Jing
AU  - Wang J
AD  - a ChaoYang Center for Disease Prevention and Control , Beijing , China.
FAU - Luo, FengJi
AU  - Luo F
AD  - a ChaoYang Center for Disease Prevention and Control , Beijing , China.
FAU - Feng, ZiJian
AU  - Feng Z
AD  - b China Center for Disease Prevention and Control ; Beijing , China.
FAU - Li, Li
AU  - Li L
AD  - a ChaoYang Center for Disease Prevention and Control , Beijing , China.
FAU - Bai, YunHua
AU  - Bai Y
AD  - a ChaoYang Center for Disease Prevention and Control , Beijing , China.
FAU - Ai, Xing
AU  - Ai X
AD  - c National Institutes for Food and Drug Control , Beijing , China.
FAU - Ma, JianXin
AU  - Ma J
AD  - a ChaoYang Center for Disease Prevention and Control , Beijing , China.
FAU - Zhang, Zheng
AU  - Zhang Z
AD  - a ChaoYang Center for Disease Prevention and Control , Beijing , China.
FAU - Shi, NianMin
AU  - Shi N
AD  - a ChaoYang Center for Disease Prevention and Control , Beijing , China.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
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  - Age Factors
MH  - Aged
MH  - Aged, 80 and over
MH  - Animals
MH  - Antibodies, Neutralizing/blood
MH  - Antibodies, Viral/blood
MH  - China
MH  - Chlorocebus aethiops
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Female
MH  - Humans
MH  - *Immunization Schedule
MH  - Male
MH  - Middle Aged
MH  - Rabies/*prevention & control
MH  - Rabies Vaccines/administration & dosage/*adverse effects/*immunology/isolation & 
      purification
MH  - Technology, Pharmaceutical
MH  - Vero Cells
PMC - PMC5287299
OTO - NOTNLM
OT  - Essen regimen
OT  - Rabies
OT  - Rabies vaccine
OT  - Vero cell
OT  - Zagreb regimen
EDAT- 2017/01/04 06:00
MHDA- 2017/10/24 06:00
PMCR- 2018/01/03
CRDT- 2017/01/04 06:00
PHST- 2017/01/04 06:00 [pubmed]
PHST- 2017/10/24 06:00 [medline]
PHST- 2017/01/04 06:00 [entrez]
PHST- 2018/01/03 00:00 [pmc-release]
AID - 1230260 [pii]
AID - 10.1080/21645515.2016.1230260 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2017 Jan 2;13(1):144-150. doi: 
      10.1080/21645515.2016.1230260.