Clinical Trial: Zika-Vaccine Dose Finding Study Regarding Safety, Immunogenicity and Tolerability

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 H

Brief 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.


Detailed Summary:
Sponsor: Themis Bioscience GmbH

Current Primary Outcome: Immunogenicity: Functional anti-Zika antibodies as measured by PRNT [ Time Frame: 56 days ]

Functional anti-Zika antibodies as measured by PRNT.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Themis Bioscience GmbH

Dates:
Date Received: December 15, 2016
Date Started: April 4, 2017
Date Completion: August 2017
Last Updated: April 4, 2017
Last Verified: December 2016