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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Zika Virus

Intervention / Treatment
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* Biological: MV-ZIKA
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose - single shot<br>MV-ZIKA, high dose, one vaccination, day 0 | Biological: MV-ZIKA<br>* MV-Zika vaccine<br>Other: Placebo<br>* physiological saline<br>|
| Experimental: Low dose<br>MV-ZIKA, low dose, two vaccinations, day 0 and day 28 | Biological: MV-ZIKA<br>* MV-Zika vaccine<br>|
| Experimental: High dose<br>MV-ZIKA, high dose, two vaccinations, day 0 and day 28 | Biological: MV-ZIKA<br>* MV-Zika vaccine<br>|
| Placebo Comparator: Placebo<br>Physiological saline, two treatments | Other: Placebo<br>* physiological saline<br>|

What is the study measuring?
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Primary Outcome Measures

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