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

Phase 1

Completed

• Conditions: Zika Virus
• Interventions: Biological: MV-ZIKA; Other: Placebo

• Registration Number: NCT02996890
• Lead Sponsor: Themis Bioscience GmbH

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 Description

Not available

Study Timeline

• Study First Submitted: 2016-12-15
• Study First Submitted QC: 2016-12-16
• Study First Posted: 2016-12-19
• Study Start: 2017-05-03
• Primary Completion: 2018-01-04
• Study Completion: 2018-04-17
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-17
• Last Update Posted: 2022-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• healthy volunteers aged 18 to 55
• subjects of child bearing potential must perform reliable method of contraception

Exclusion Criteria

• immune deficiency, history of HIV, HBV, HCV
• drug addiction
• vaccination within 4 weeks prior to study or planned vaccination during study
• prior receipt of any Zika vaccine
• recent infection 1 week prior to screening
• relevant medical history interfering with aim of study
• neoplastic disease, hematological malignancy
• history of autoimmune disease
• psychological condition that affects ability to participate in the study
• history of severe adverse reactions to vaccine administration
• history of anaphylaxis
• allergic reactions, abnormal lab values, or concomitant medication per decision of the investigator
• use of immunosuppressive drugs within 30 days before screening or planned use during study
• receipt of blood products within 120 days before screening or planned use during study
• pregnancy, unreliable contraception method
• decision of the investigator
• regular blood plasma donor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose - single shot	Placebo	MV-ZIKA, high dose, one vaccination, day 0
Low dose	MV-ZIKA	MV-ZIKA, low dose, two vaccinations, day 0 and day 28
Placebo	Placebo	Physiological saline, two treatments
High dose - single shot	MV-ZIKA	MV-ZIKA, high dose, one vaccination, day 0
High dose	MV-ZIKA	MV-ZIKA, high dose, two vaccinations, day 0 and day 28

Primary Outcome Measures

Name	Time	Method
Immunogenicity: Functional anti-Zika antibodies as measured by PRNT	56 days	Functional anti-Zika antibodies as measured by PRNT.

Trial Locations

Locations (2)

Medical University of Vienna, Center for Pathophysiology, Infectiology and Immunology; 🇦🇹 Vienna, Austria

Medical University of Vienna, Department of Clinical Pharmacology; 🇦🇹 Vienna, Austria