At a glance
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Observer Blinded, Randomized Trial to Evaluate Safety and Immunogenicity of a Novel Vaccine Formulation MV-ZIKA-RSP
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
Timeline
Interventions
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)
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)
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
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