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

NCT02996890 | Completed Phase 1

• 3 other identifiers: V186-0012016-004212-34MV-ZIKA-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Immunogenicity: Functional anti-Zika antibodies as measured by PRNT

  Functional anti-Zika antibodies as measured by PRNT.

  56 days

Study Arms (4)

High dose - single shot

EXPERIMENTAL

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

Biological: MV-ZIKA; Other: Placebo

Low dose

EXPERIMENTAL

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

Biological: MV-ZIKA

High dose

EXPERIMENTAL

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

Biological: MV-ZIKA

Placebo

PLACEBO COMPARATOR

Physiological saline, two treatments

Other: Placebo

Interventions

MV-ZIKA BIOLOGICAL

MV-Zika vaccine

High dose; High dose - single shot; Low dose

Placebo OTHER

physiological saline

High dose - single shot; Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Themis Bioscience GmbH: lead

Study Sites (2)

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

Vienna, 1090, Austria

Location

Medical University of Vienna, Department of Clinical Pharmacology

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Zika Virus Infection

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: December 19, 2016
• Study Start: May 3, 2017
• Primary Completion: January 4, 2018
• Study Completion: April 17, 2018
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

AU (2)