drugset / Trial / NCT04033068

Safety and Immunogenicity of a Novel Vaccine Formulation MV-ZIKA-RSP (V187-001)

NCT04033068 ↗

Phase 1 Completed 48 enrolled Themis Bioscience GmbH
RandomizedParallel-groupQuadruple-blindPrevention

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

Timeline

Start
2019-08-02
Primary completion
2020-01-30
Completion
2020-06-10

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

registry analysis (superiority test); Group A: V187 (High Dose) - V187 (High Dose) vs Group B: V187 (Low Dose) - V187 (Low Dose) vs Group C: V187 (High Dose) - Placebo vs Group D: Placebo - Placebo; p = 0.2003; Fisher-Freeman-Halton Test NCT04033068 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject MV-ZIKA-RSP Vaccine 25000 unknown —
Subject MV-ZIKA-RSP Vaccine 100000 unknown —