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

NCT ID: NCT02996890

Last Updated: 2022-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-03
• Study Completion Date: 2018-04-17

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.

Conditions

Zika Virus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

High dose - single shot

MV-ZIKA, high dose, one vaccination, day 0

Group Type: EXPERIMENTAL

MV-ZIKA

Intervention Type: BIOLOGICAL

MV-Zika vaccine

Placebo

Intervention Type: OTHER

physiological saline

Low dose

MV-ZIKA, low dose, two vaccinations, day 0 and day 28

Group Type: EXPERIMENTAL

MV-ZIKA

Intervention Type: BIOLOGICAL

MV-Zika vaccine

High dose

MV-ZIKA, high dose, two vaccinations, day 0 and day 28

Group Type: EXPERIMENTAL

MV-ZIKA

Intervention Type: BIOLOGICAL

MV-Zika vaccine

Placebo

Physiological saline, two treatments

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

physiological saline

Interventions

MV-ZIKA

MV-Zika vaccine

Intervention Type: BIOLOGICAL

Placebo

physiological saline

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Themis Bioscience GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Medical University of Vienna, Center for Pathophysiology, Infectiology and Immunology

Vienna, , Austria

Medical University of Vienna, Department of Clinical Pharmacology

Vienna, , Austria

Countries

Austria

Other Identifiers

2016-004212-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MV-ZIKA-101

Identifier Type: OTHER

Identifier Source: secondary_id

V186-001

Identifier Type: -

Identifier Source: org_study_id