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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02996890

Enrollment

Registered

2016-12-19

Start date

2017-05-03

Completion date

2018-04-17

Last updated

2022-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Zika Virus

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.

Interventions

BIOLOGICALMV-ZIKA

MV-Zika vaccine

OTHERPlacebo

physiological saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026