- |||||||||| Zika virus immune globulin (ZIKV-IG) / Emergent Biosolutions
Clinical, P1 data, PK/PD data, Journal: Results of a Double-Blind, Randomized, Placebo-Controlled Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Anti-Zika Virus Immunoglobulin. (Pubmed Central) - Feb 22, 2022
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-∞ of 77,224 h × 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.
- |||||||||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion, Zika virus immune globulin (ZIKV-IG) / Emergent Biosolutions
Journal: The Ability of Zika virus Intravenous Immunoglobulin to Protect From or Enhance Zika Virus Disease. (Pubmed Central) - Dec 22, 2021
Using this approach, we were able to define the unique in vivo dynamics of complex polyclonal antibodies, allowing for both enhancement and protection from flavivirus infection. Our results provide a novel understanding of how polyclonal antibodies interact with viruses with implications for the use of polyclonal antibody therapeutics and the development and evaluation of the next generation flavivirus vaccines.
- |||||||||| ZIKV-IG / Emergent Biosolutions
Preclinical, Journal: Human Polyclonal Antibodies Prevent Lethal Zika Virus Infection in Mice. (Pubmed Central) - Oct 27, 2020
Additionally, ZIKV-IG eliminated ZIKV-induced tissue damage and inflammation in the brain and liver. These results indicate that ZIKV-IG is efficacious against ZIKV, suggesting this human polyclonal antibody is a viable candidate for further development as a treatment against human ZIKV infection.
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