PMID- 28406752
OWN - NLM
STAT- MEDLINE
DCOM- 20180314
LR  - 20181113
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 13
IP  - 7
DP  - 2017 Jul 3
TI  - Comparison of the immunogenicity and safety of the purified chick embryo cell 
      rabies vaccine manufactured in India and Germany: A randomized, single blind, 
      multicentre, phase IV clinical study.
PG  - 1531-1538
LID - 10.1080/21645515.2017.1307483 [doi]
AB  - This phase IV, single blind study assessed the immunogenicity and safety of 
      India-manufactured purified chick embryo cell rabies vaccine (PCECV), compared 
      with a German-manufactured batch obtained by the same production process. A total 
      of 340 participants enrolled at 2 study sites in India were randomized (1:1:1:1) 
      in 4 groups to receive a 5-dose Essen regimen with either 1 of the 3 Indian 
      batches (PCECV-I) or the German batch (PCECV-G), administered on Days (D) 0, 3, 
      7, 14 and 30. The lot-to-lot consistency of PCECV-I batches in terms of induced 
      immune response at D14 was demonstrated. The immune response elicited by PCECV-I 
      was shown to be non-inferior to that induced by PCECV-G, as the lower limit of 
      the 95% confidence interval for the ratio (PCECV-I/PCECV-G) of rabies virus 
      neutralising antibody (RVNA) geometric mean concentrations was higher than 0.5 at 
      D14. At least 96% of participants developed adequate RVNA concentrations (>/= 
      0.5 IU/mL) by D14 and all achieved RVNA concentrations >/= 0.5 IU/mL by D90. RVNA 
      levels were comparable across all groups throughout the entire study. Solicited 
      local and general symptoms had a similar incidence in all groups. Unsolicited 
      adverse events (AEs) were reported by 11% of participants. Only 1 serious AE (leg 
      fracture) was reported and was not related to vaccination. No deaths and no 
      rabies cases were recorded during the 90 days of observation. The study showed 
      that the 3 PCECV-I and the PCECV-G batches induced a similar immune response and 
      had a comparable safety profile when administered according to a 5-dose schedule.
FAU - Sampath, Gadey
AU  - Sampath G
AD  - a Institute of Preventive Medicine, Anti-Rabies Clinic , Hyderabad , India.
FAU - Banzhoff, Angelika
AU  - Banzhoff A
AD  - b GSK Vaccines GmbH , Marburg , Germany.
FAU - Deshpande, Alaka
AU  - Deshpande A
AD  - c Department of Medicine , Grant Medical College , Mumbai , India.
FAU - Malerczyk, Claudius
AU  - Malerczyk C
AD  - b GSK Vaccines GmbH , Marburg , Germany.
FAU - Arora, Ashwani Kumar
AU  - Arora AK
AD  - d GSK Vaccines , Siena , Italy.
FAU - Vakil, Hoshang
AU  - Vakil H
AD  - e GSK Vaccines , Mumbai , India.
FAU - Preiss, Scott
AU  - Preiss S
AD  - f GSK Vaccines , Wavre , Belgium.
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20170413
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  - Adult
MH  - Aged
MH  - Animals
MH  - Antibodies, Neutralizing/*blood
MH  - Antibodies, Viral/*blood
MH  - Cell Culture Techniques
MH  - Chick Embryo
MH  - Child
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology/pathology
MH  - Female
MH  - Germany
MH  - Humans
MH  - Immunization Schedule
MH  - Incidence
MH  - India
MH  - Male
MH  - Middle Aged
MH  - Rabies Vaccines/administration & dosage/*adverse effects/*immunology/isolation & 
      purification
MH  - Rabies virus/*immunology
MH  - Single-Blind Method
MH  - Technology, Pharmaceutical
MH  - Young Adult
PMC - PMC5512782
OTO - NOTNLM
OT  - PCEC vaccine
OT  - immunogenicity
OT  - lot-to-lot consistency
OT  - rabies
OT  - safety
EDAT- 2017/04/14 06:00
MHDA- 2018/03/15 06:00
PMCR- 2017/04/13
CRDT- 2017/04/14 06:00
PHST- 2017/04/14 06:00 [pubmed]
PHST- 2018/03/15 06:00 [medline]
PHST- 2017/04/14 06:00 [entrez]
PHST- 2017/04/13 00:00 [pmc-release]
AID - 1307483 [pii]
AID - 10.1080/21645515.2017.1307483 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2017 Jul 3;13(7):1531-1538. doi: 
      10.1080/21645515.2017.1307483. Epub 2017 Apr 13.