Zika virus immune globulin (ZIKV-IG) / Emergent Biosolutions - LARVOL DELTA

Results of a Double-Blind, Randomized, Placebo-Controlled Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Anti-Zika Virus Immunoglobulin. (PubMed, Am J Trop Med Hyg) - "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."

Clinical • Journal • P1 data • PK/PD data • Infectious Disease • Ophthalmology • Pain

The Ability of Zika virus Intravenous Immunoglobulin to Protect From or Enhance Zika Virus Disease. (PubMed, Front Immunol) - "Three IVIGs (ZIKV-IG, Control-Ig and Gamunex) were evaluated for their ability to neutralize and/or enhance Zika, dengue 2 and 3 viruses in vitro. 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."

Journal • Dengue Fever • Infectious Disease

Human Polyclonal Antibodies Prevent Lethal Zika Virus Infection in Mice. (PubMed, Sci Rep) - "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."

Journal • Preclinical • Immunology • Infectious Disease • Inflammation

Study in Healthy Volunteers Evaluating Safety and Pharmacokinetics of Zika Virus Immune Globulin (ZIKV-IG) (clinicaltrials.gov) - P1; N=30; Completed; Sponsor: Emergent BioSolutions; Active, not recruiting ➔ Completed

Clinical • Trial completion

Study in Healthy Volunteers Evaluating Safety and Pharmacokinetics of Zika Virus Immune Globulin (ZIKV-IG) (clinicaltrials.gov) - P1; N=30; Active, not recruiting; Sponsor: Emergent BioSolutions; Recruiting ➔ Active, not recruiting

Enrollment closed