PMID- 34610572
OWN - NLM
STAT- MEDLINE
DCOM- 20220221
LR  - 20220221
IS  - 1476-1645 (Electronic)
IS  - 0002-9637 (Print)
IS  - 0002-9637 (Linking)
VI  - 105
IP  - 6
DP  - 2021 Oct 4
TI  - Results of a Double-Blind, Randomized, Placebo-Controlled Phase 1 Study to 
      Evaluate the Safety and Pharmacokinetics of Anti-Zika Virus Immunoglobulin.
PG  - 1552-1562
LID - tpmd201578 [pii]
LID - 10.4269/ajtmh.20-1578 [doi]
AB  - Zika virus (ZIKV) is transmitted primarily through infected Aedes aegypti or 
      Aedes albopictus mosquitoes. ZIKV infection during pregnancy was linked to 
      adverse fetal/infant outcomes, including microcephaly, brain anomalies, ocular 
      disorders, intrauterine growth restriction, and other congenital malformations. 
      Human anti-Zika virus immunoglobulin (ZIKV-Ig) is being developed for prophylaxis 
      of ZIKV in at-risk populations, including women of childbearing potential and 
      pregnant women. A phase 1 single-center, double-blind, randomized, 
      placebo-controlled study was conducted to assess the safety and pharmacokinetics 
      (PK) of a single 50.0-mL ZIKV-Ig intravenous dose in healthy adult male or 
      non-pregnant female subjects 18 to 55 years of age. Subjects received either 
      ZIKV-Ig (n = 19) or saline placebo (n = 11). Safety was evaluated based on 
      adverse events (AEs), laboratory test results, physical examinations, and vital 
      signs. Overall, there were 11 subjects (36.7%) with treatment-related AEs 
      including eight subjects (42.1%) in the ZIKV-Ig group and three subjects (27.3%) 
      in the placebo group. Of the AEs considered treatment related, three subjects 
      (15.8%) experienced headache (mild). There were no serious AEs, no deaths, and no 
      discontinuations resulting from AEs. Overall, the safety profile of ZIKV-Ig in 
      this study population of healthy adult subjects appeared to be safe and well 
      tolerated. The results of the pharmacokinetic analysis determined that ZIKV-Ig 
      had a maximum observed concentration of 182.3 U/mL (coefficient of variation, 
      21.3%), the time at which Cmax occurred of 2.3 hours +/- 1.0 (SD), an area under 
      the concentration-time curve0-infinity of 77,224 h x U/mL (coefficient of variation, 
      17.9%), and a half-life of 28.1 days, which is similar to other human-derived 
      commercial Ig intravenous products.
FAU - White, Jane
AU  - White J
AD  - Emergent BioSolutions Inc., Gaithersburg, Maryland.
FAU - Tunga, Priya
AU  - Tunga P
AD  - Emergent BioSolutions Canada Inc., Winnipeg, Manitoba, Canada.
FAU - Anderson, Deborah M
AU  - Anderson DM
AD  - Emergent BioSolutions Canada Inc., Winnipeg, Manitoba, Canada.
FAU - Iledan, Ken
AU  - Iledan K
AD  - Emergent BioSolutions Canada Inc., Winnipeg, Manitoba, Canada.
FAU - Loreth, Tobi
AU  - Loreth T
AD  - Emergent BioSolutions Canada Inc., Winnipeg, Manitoba, Canada.
FAU - Parrera, Geraldine S
AU  - Parrera GS
AD  - Emergent BioSolutions Canada Inc., Winnipeg, Manitoba, Canada.
FAU - Astacio, Hugo
AU  - Astacio H
AD  - Emergent BioSolutions Canada Inc., Winnipeg, Manitoba, Canada.
FAU - Drobic, Bojan
AU  - Drobic B
AD  - Emergent BioSolutions Canada Inc., Winnipeg, Manitoba, Canada.
FAU - Richardson, Jason S
AU  - Richardson JS
AD  - Emergent BioSolutions Canada Inc., Winnipeg, Manitoba, Canada.
LA  - eng
SI  - ClinicalTrials.gov/NCT03624946
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20211004
PL  - United States
TA  - Am J Trop Med Hyg
JT  - The American journal of tropical medicine and hygiene
JID - 0370507
RN  - 0 (Immunoglobulin G)
SB  - IM
MH  - Adult
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Immunization, Passive/*methods
MH  - Immunoglobulin G/immunology/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Pharmacokinetics
MH  - Young Adult
MH  - Zika Virus/immunology
MH  - Zika Virus Infection/*therapy
PMC - PMC8641324
EDAT- 2021/10/06 06:00
MHDA- 2022/02/22 06:00
PMCR- 2021/10/04
CRDT- 2021/10/05 20:19
PHST- 2020/12/12 00:00 [received]
PHST- 2021/08/06 00:00 [accepted]
PHST- 2021/10/06 06:00 [pubmed]
PHST- 2022/02/22 06:00 [medline]
PHST- 2021/10/05 20:19 [entrez]
PHST- 2021/10/04 00:00 [pmc-release]
AID - tpmd201578 [pii]
AID - 10.4269/ajtmh.20-1578 [doi]
PST - epublish
SO  - Am J Trop Med Hyg. 2021 Oct 4;105(6):1552-1562. doi: 10.4269/ajtmh.20-1578.