PMID- 29983597
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220318
IS  - 1179-1438 (Print)
IS  - 1179-1438 (Electronic)
IS  - 1179-1438 (Linking)
VI  - 10
DP  - 2018
TI  - Safety and neutralizing rabies antibody in healthy subjects given a single dose 
      of rabies immune globulin caprylate/chromatography purified.
PG  - 79-88
LID - 10.2147/CPAA.S166454 [doi]
AB  - BACKGROUND: Rabies immune globulin (RIG) and vaccination series are necessary for 
      postexposure prophylaxis. A new formulation of RIG (human) purified by 
      caprylate/chromatography (RIG-C) was evaluated. TRIAL REGISTRATION: 
      ClinicalTrials.gov identifier: NCT02139657. MATERIALS AND METHODS: This 
      open-label, single-arm study in healthy subjects evaluated neutralizing rabies 
      antibody concentrations produced from a single 20 IU/kg intramuscular (IM) dose 
      of RIG-C as measured by rapid fluorescent focus inhibition test (50% 
      neutralization endpoint) 1-hour postdose and on days 1, 2, 4, 6, 8, 10, 14, 18, 
      and 21. RESULTS: Twelve subjects were enrolled into the study. No 
      discontinuations, serious adverse events (AEs), or treatment-emergent clinically 
      significant changes in laboratory parameters were observed. All AEs resolved and 
      were mild except 1 moderate AE of oropharyngeal pain. Injection site pain (4 
      subjects) was most commonly reported. RIG-C produced a rapid increase in 
      neutralizing rabies antibody: mean value 0.113 IU/mL at 24 hours after IM 
      injection, peak on day 4 (0.132 IU/mL), persisting through day 21 (0.116 IU/mL). 
      The mean reciprocal titer was 11.5 by day 2; the peak value of 12.1 was achieved 
      on day 4; and a mean value >/=10.6 was maintained through day 21. CONCLUSION: RIG-C 
      was well tolerated and provided neutralizing rabies antibodies, which combined 
      with vaccine series after rabies exposure, should result in effective prophylaxis 
      per World Health Organization/Centers for Disease Control and Prevention 
      guidelines.
FAU - Hanna, Kim
AU  - Hanna K
AD  - Grifols Bioscience Research Group, Grifols Inc, Research Triangle Park, NC, USA, 
      elsa.mondou@grifols.com.
FAU - Cruz, Maria Cristina
AU  - Cruz MC
AD  - Grifols Bioscience Research Group, Grifols Inc, Research Triangle Park, NC, USA, 
      elsa.mondou@grifols.com.
FAU - Mondou, Elsa
AU  - Mondou E
AD  - Grifols Bioscience Research Group, Grifols Inc, Research Triangle Park, NC, USA, 
      elsa.mondou@grifols.com.
FAU - Corsi, Edward
AU  - Corsi E
AD  - Grifols Bioscience Research Group, Grifols Inc, Research Triangle Park, NC, USA, 
      elsa.mondou@grifols.com.
FAU - Vandeberg, Peter
AU  - Vandeberg P
AD  - Grifols Bioscience Research Group, Grifols Inc, Research Triangle Park, NC, USA, 
      elsa.mondou@grifols.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT02139657
PT  - Journal Article
DEP - 20180626
PL  - New Zealand
TA  - Clin Pharmacol
JT  - Clinical pharmacology : advances and applications
JID - 101564865
PMC - PMC6027702
OTO - NOTNLM
OT  - GTI1301
OT  - RIG-C
OT  - prophylaxis
OT  - rabies
OT  - rabies immune globulin
OT  - rabies neutralizing antibody titers
COIS- Disclosure All the authors are employees of Grifols and report personal fees from 
      Grifols during the conduct of the study. The authors report no other conflicts of 
      interest in this work.
EDAT- 2018/07/10 06:00
MHDA- 2018/07/10 06:01
PMCR- 2018/06/26
CRDT- 2018/07/10 06:00
PHST- 2018/07/10 06:00 [entrez]
PHST- 2018/07/10 06:00 [pubmed]
PHST- 2018/07/10 06:01 [medline]
PHST- 2018/06/26 00:00 [pmc-release]
AID - cpaa-10-079 [pii]
AID - 10.2147/CPAA.S166454 [doi]
PST - epublish
SO  - Clin Pharmacol. 2018 Jun 26;10:79-88. doi: 10.2147/CPAA.S166454. eCollection 
      2018.