NCT02996890

Zika-Vaccine Dose Finding Study Regarding Safety, Immunogenicity and Tolerability (V186-001)

Double Blinded, Randomized, Placebo Controlled, Dose Finding Trial to Evaluate the Optimal Dose of MV-ZIKA, a New Vaccine Against Zika Virus, in Regard to Immunogenicity, Safety, and Tolerability in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Themis Bioscience GmbH · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Double blinded, randomized, placebo-controlled, dose finding, multi-center, phase 1 trial in 48 healthy volunteer subjects. After completion of screening procedures, the subjects are randomized to one of four treatment groups (different dosage strengths and placebo) All subjects will receive study treatment at day 0 and will return on day 28. Subjects randomized to treatment groups with two vaccinations will receive a second treatment at day 28. Subjects will return on day 56 for the final visit.

Conditions

• Zika Virus

Interventions

Type	Name	Description
BIOLOGICAL	MV-ZIKA	MV-Zika vaccine
OTHER	Placebo	physiological saline

Timeline

• Start date: 2017-05-03
• Primary completion: 2018-01-04
• Completion: 2018-04-17
• First posted: 2016-12-19
• Last updated: 2022-08-18

Locations

2 sites across 1 country: Austria