PMID- 24672132
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20140327
LR  - 20211021
IS  - 0011-393X (Print)
IS  - 0011-393X (Linking)
VI  - 66
IP  - 4
DP  - 2005 Jul
TI  - Evaluation of a new five-injection, two-site,intradermal schedule for purified 
      chick embryo cell rabies vaccine: A randomized, open-label, active-controlled 
      trial in healthy adult volunteers in India.
PG  - 323-34
LID - 10.1016/j.curtheres.2005.08.009 [doi]
AB  - BACKGROUND: Human rabies is an ongoing significant public health problem inmany 
      developing countries, with India reporting the highest incidence of 
      rabies-related deaths ( approximately 20,000 per year). Many people living in India cannot 
      afford the standard IM postexposure prophylaxis (PEP) with cell-culture vaccines, 
      which are administered using a 5-dose regimen developed in Essen, Germany. A 
      potentially less expensive intradermal (ID) regimen, based on the Essen regimen, 
      has been developed at the Kempegowda Institute of Medical Sciences (KIMS), 
      Bangalore, India. OBJECTIVE: The objective of this study was to compare the 
      immunogenicity and local and systemic tolerability of the KIMS-1D regimen with 
      those of the standard Essen IM regimen in healthy adult volunteers in India. 
      METHODS: This randomized, open-label, active-controlled trial was conductedat the 
      Antirabies Clinic, Medical College, KIMS. Healthy adult volunteers were randomly 
      assigned to receive purified chick embryo cell vaccine (PCECV) using the KIMS-1D 
      regimen (0.1 mL injected ID at 2 body sites on days 0, 3, 7, 14, and 28 
      ["2-2-2-2-2"]) or the Essen IM regimen (1 mL injected IM at 1 body site on the 
      same days Subjects were followed up for 365 days by the treating physician and 
      encouraged to voluntarily report any adverse events (AEs). Serum rabies 
      virus-neutralizing antibody (RVNA) concentrations were measured before the first 
      injection on day 0 (baseline) and on days 14, 28, 90, 180, and 365, using the 
      rapid fluorescent focus inhibition test. RESULTS: Ninety-one subjects were 
      enrolled and included in the tolerabilityand immunogenicity analyses. The ID 
      group comprised 45 subjects (26 men, 19 women; mean [SD] age, 20.84 [1.48] 
      years); the IM group, 46 subjects (28 men, 18 women; mean [SD] age, 21.02 [1.16] 
      years). The most common local AEs were pain at the injection site (2/225 [0.9%] 
      in the ID group and 10/230 [4.3%] in the IM group; P < 0.006) and itching at the 
      injection site (5/225 [2.2%] in the ID group and none in the IM group; P = 
      0.026). All of the AEs were transient and resolved without the need for 
      medication. All subjects had serum RVNA concentrations >/=0.5 IU/mL-considered 
      protective by the World Health Organization-at all follow-up visits. However, the 
      mean RVNA concentrations in the IM group were significantly higher compared with 
      those in the ID group from days 14 to 365 (all, P < 0.001). CONCLUSION: In this 
      study in healthy volunteers, PEP with PCECV administered using the KIMS-ID 
      regimen was well tolerated and immunologically efficacious for 365 days. Adequate 
      RVNA levels were maintained with the KIMS-ID regimen from days 14 to 365, 
      although these levels were significantly lower than those achieved in the group 
      receiving the Essen IM regimen (all, P < 0.001).
FAU - Sudarshan, M K
AU  - Sudarshan MK
AD  - Department of Community Medicine, Kempegowda Institute of Medical 
      Sciences,Bangalore, India.
FAU - Madhusudana, S N
AU  - Madhusudana SN
AD  - Department of Neurovirology, National Institute of Mental Health and 
      Neurosciences, Bangalore, India.
FAU - Mahendra, B J
AU  - Mahendra BJ
AD  - Department of Community Medicine, Kempegowda Institute of Medical 
      Sciences,Bangalore, India.
FAU - Ashwath Narayana, D H
AU  - Ashwath Narayana DH
AD  - Department of Community Medicine, Kempegowda Institute of Medical 
      Sciences,Bangalore, India.
FAU - Ananda Giri, M S
AU  - Ananda Giri MS
AD  - Department of Community Medicine, Kempegowda Institute of Medical 
      Sciences,Bangalore, India.
FAU - Popova, O
AU  - Popova O
AD  - Clinical Research and Medical Affairs, Chiron Vaccines,Siena, Italy.
FAU - Vakil, H B
AU  - Vakil HB
AD  - Clinical Research and Medical Affairs, Chiron Vaccines, Mumbai, India.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Curr Ther Res Clin Exp
JT  - Current therapeutic research, clinical and experimental
JID - 0372621
PMC - PMC3964532
OTO - NOTNLM
OT  - KIMS-ID regimen
OT  - intradermal rabies vaccination
OT  - rabies
OT  - randomizedcontrolled trial
EDAT- 2005/07/01 00:00
MHDA- 2005/07/01 00:01
PMCR- 2005/07/01
CRDT- 2014/03/28 06:00
PHST- 2005/06/07 00:00 [accepted]
PHST- 2014/03/28 06:00 [entrez]
PHST- 2005/07/01 00:00 [pubmed]
PHST- 2005/07/01 00:01 [medline]
PHST- 2005/07/01 00:00 [pmc-release]
AID - S0011-393X(05)00080-9 [pii]
AID - 10.1016/j.curtheres.2005.08.009 [doi]
PST - ppublish
SO  - Curr Ther Res Clin Exp. 2005 Jul;66(4):323-34. doi: 
      10.1016/j.curtheres.2005.08.009.