NCT04015648

Safety and Immunogenicity of a Candidate ZIKV Vaccine (ZIKA001)

A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Zika Virus (ZIKV) Vaccine ChAdOx1 Zika in Healthy Adult Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a FIH, open-label, dose escalation, phase I clinical trial to assess the safety and immunogenicity of the candidate ChAdOx1 Zika vaccine in healthy volunteers administered intramuscularly.

Detailed description

Volunteers will be recruited and vaccinated at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford. There will be 3 study groups and a total of 24 volunteers will be enrolled. Groups 1-3 will receive ChAdOx1 Zika alone. Staggered enrolment will apply for the first three volunteers within each group.

Conditions

• Zika

Interventions

Type	Name	Description
BIOLOGICAL	ChAdOx1 Zika	Single dose of ChAdOx1 Zika at different concentrations: 5 x 10\^9 vp, 2.5 x 10\^10 vp, 5 x 10\^10 vp

Timeline

• Start date: 2019-10-21
• Primary completion: 2022-03-10
• Completion: 2022-03-10
• First posted: 2019-07-11
• Last updated: 2022-05-18

Locations

1 site across 1 country: United Kingdom