CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 48 enrolled
Drug / intervention
Two MV-ZIKA-RSP vaccinations (high dose) +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04033068
NCT04033068Phase 1Completed

Observer Blinded, Randomized Trial to Evaluate Safety and Immunogenicity of a Novel Vaccine Formulation MV-ZIKA-RSP

Themis Bioscience GmbH·interventional·Posted Jul 25, 2019·Updated Dec 6, 2021

In Brief

A Phase 1 clinical trial evaluating Two MV-ZIKA-RSP vaccinations (high dose), Two MV-ZIKA-RSP vaccination (low dose), and 2 other interventions for Zika Virus Infection. Completed, enrolled 48 participants across 1 site.

Detailed Summary

This study is designed to investigate, at first, safety and tolerability of a novel liquid vaccine formulation named MV-ZIKA-RSP, in healthy adults aged 18 to 55 years

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedJul 25, 2019
Enrollment StartAug 2, 2019
Primary CompletionJan 30, 2020
Study CompletionJun 10, 2020
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 6.9 years ago

Interventions

Two MV-ZIKA-RSP vaccinations (high dose)biological

In this arm of the study, 14 participants will receive: 1. V1= day 0; dose vaccination with MV-ZIKA-RSP (high dose). 2. V2= day 28; dose vaccination with MV-ZIKA-RSP (high dose). Description: Visit 1: Participants will receive their first vaccination with MV-ZIKA-RSP (high dose) Visit 2: Participants will receive their second vaccination with MV-ZIKA-RSP (high dose)

Two MV-ZIKA-RSP vaccination (low dose)biological

In this arm of the study, 14 participants will receive: 1. V1= day 0; dose vaccination with MV-ZIKA-RSP (low dose). 2. V2= day 28; dose vaccination with MV-ZIKA-RSP (low dose). Description: Visit 1: Participants will receive their first vaccination with MV-ZIKA-RSP (low dose) Visit 2: Participants will receive their second vaccination with MV-ZIKA-RSP (low dose)

One MV-ZIKA-RSP vaccination (high dose) and one placebobiological

In this arm of the study, 12 participants will receive: 1. V1= day 0; dose vaccination with MV-ZIKA-RSP (high dose). 2. V2= day 28; treatment with placebo Description: Visit 1: Participants will receive their first vaccination with MV-ZIKA-RSP (high dose) Visit 2: Participants will receive their second treatment with placebo

Two placebo injectionother

In this arm of the study, 8 participants will receive: 1. V1= day 0; placebo treatment 2. V2= day 28; placebo treatment Description: Visit 1: Participants will receive their first treatment with placebo Visit 2: Participants will receive their second treatment with placebo