Clinical Trials Logo

Clinical Trial Summary

Currently, there are no licensed therapeutics against Zika virus infection. Due to this unmet medical need, Zika Virus Immune Globulin (ZIKV-IG) is being developed as a therapeutic intervention against Zika virus infection. In this first-in-human study, evaluation of ZIKV-IG safety and pharmacokinetics (absorption, metabolism and excretion) will be conducted in healthy adult volunteers.


Clinical Trial Description

This study will be evaluating safety and pharmacokinetics (PK) of one dose level of ZIKV-IG (50 mL) in healthy adult volunteers. The study is a single-center, double-blind, randomized and placebo-controlled design. The primary objective is to assess safety of intravenously (IV) administered ZIKV-IG, while the secondary objective is to determine the PK profile of ZIKV-IG in healthy adult volunteers. There will be a total of 30 subjects enrolled into the study; dosing of the first six subjects will be staggered over three separate days, wherein two subjects per day will be randomized 1:1 to either receive 50 mL of placebo IV or 50 mL of ZIKV-IG IV (the total amount of gamma immune globulin [IgG] protein from a single 50mL dose is 4.65g). After the first six subjects are dosed, the remaining 24 subjects will be randomized 2:1 to receive either ZIKV-IG or placebo. A safety monitoring committee will review safety data (collected up to 3 days post-dosing) of the first 12 dosed subjects prior to dosing of the remaining 18 subjects. Overall, there will be 19 subjects randomized to receive ZIKV-IG and 11 subjects randomized to receive placebo on Day 1. On Day 1 (post-dose at 1 hour, 3 hours, 8 hours) and Day 2, safety and PK assessments will be conducted while the subjects are in the Phase 1 clinic. After the discharge on Day 2, the subjects will come back to the clinic for safety and PK assessments on Days 3, 4, 6, 8, 10, 12, 15, 22, 29, 43, 57 and 85. Total study duration for each subject will be up to 4 months (from screening to Day 85). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03624946
Study type Interventional
Source Emergent BioSolutions
Contact
Status Completed
Phase Phase 1
Start date June 27, 2018
Completion date March 6, 2019

See also
  Status Clinical Trial Phase
Completed NCT04697147 - Zika and Neurodevelopment Among Infants in Grenada N/A
Completed NCT03631719 - Impact of Wolbachia Deployment on Arboviral Disease Incidence in Medellin and Bello, Colombia
Completed NCT02952833 - ZIKA Vaccine in Naive Subjects Phase 1
Terminated NCT03055585 - Applying Wolbachia to Eliminate Dengue N/A
Not yet recruiting NCT05589012 - Evaluation of Viral Replication by Tonate Virus (TONV) and Zika Virus (ZIKV), Within an ex Vivo Trophoblast and Placental Model
Completed NCT02963909 - A Phase 1, First-in-human, Double-blinded, Randomized, Placebo-controlled Trial of a Zika Virus Purified Inactivated Vaccine (ZPIV) With Alum Adjuvant in Healthy Flavivirus-naive and Flavivirus-Primed Subjects. Phase 1
Completed NCT03110770 - VRC 705: A Zika Virus DNA Vaccine in Healthy Adults and Adolescents Phase 2
Terminated NCT03161444 - Estimated Cumulative Incidence of Zika Infection at the End of the First Epidemic in the French West Indies in a Sample of Patients Followed for HIV Infection. N/A
Completed NCT03008122 - Phase I, Randomized, Double-blinded, Placebo-Controlled Dose De-escalation Study to Evaluate Safety and Immunogenicity of Alum Adjuvanted Zika Virus Purified Inactivated Vaccine (ZPIV) in Adults in a Flavivirus Endemic Area Phase 1
Completed NCT04478656 - Safety and Immunogenicity of BBV121 Phase 1
Completed NCT03330600 - Efficacy of Aquatic Physiotherapy in Children With Microcephaly by Zika Virus Congenital Syndrome N/A
Completed NCT05041439 - Adherence to Care for Children With Congenital Zika Virus Infection in Puerto Rico N/A
Recruiting NCT03255369 - Vertical Exposure to Zika Virus and Its Consequences for Child Neurodevelopment (ZIKVIRUSIFF)
Completed NCT03206541 - Neurologic Manifestations of the Arbovirus Infection in Colombia
Completed NCT03425149 - Randomized, Placebo-controlled, Observer-blinded Phase 1 Safety and Immunogenicity Study of Inactivated Zika Virus Vaccine Candidate in Healthy Adults Phase 1
Completed NCT04033068 - Safety and Immunogenicity of a Novel Vaccine Formulation MV-ZIKA-RSP (V187-001) Phase 1
Completed NCT03679728 - Sensorimotor Outcomes of Children Exposed to Foetal Zika Virus Infection
Completed NCT03776903 - Evaluation of the Clinical Performance of the ZIKV Detectâ„¢ 2.0 IgM Capture ELISA
Withdrawn NCT03204409 - ZIKAlliance Natural History Study