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

Zika Virus Clinical Trial

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 Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02996890
• Other study ID #: V186-001
• Secondary ID: 2016-004212-34MV
• Status: Completed
• Phase: Phase 1
• Start date: May 3, 2017
• Est. completion date: April 17, 2018

Study information

• Verified date: August 2022
• Source: Themis Bioscience GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 17, 2018
• Est. primary completion date: January 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Zika Virus
• Zika Virus Infection

Intervention

Biological:
• MV-ZIKA
MV-Zika vaccine

Other:
• Placebo
physiological saline

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Center for Pathophysiology, Infectiology and Immunology	Vienna
Austria	Medical University of Vienna, Department of Clinical Pharmacology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Themis Bioscience GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity: Functional anti-Zika antibodies as measured by PRNT	Functional anti-Zika antibodies as measured by PRNT.	56 days