NCT04033068

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Themis Bioscience GmbH · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed description

This is an observer-blinded, block-randomized, dose-finding, phase I trial, comparing different dose levels of MV-ZIKA-RSP to evaluate the safety, tolerability, and immunogenicity, of this novel ZIKA-RSP vaccine. Placebo (physiological saline solution) will be applied to blind the different treatment schedules. After the screening procedures, 48 healthy male and female volunteers aged 18-55 years will be randomly assigned to one of four treatment groups (A, B, C or D). Participants will be assessed for immunogenicity on days 0, 28 and 56 (treatment period), as confirmed by the presence of functional anti-zika-rsp antibodies determined by (PRNT50) and by ELISA, at the same time safety will be also assessed. After the treatment period, participants will be called by phone (day 182) for evaluation of safety follow-up. The investigator and site personnel assessing AEs, all participants, as well as one of the sponsor's representatives involved in the monitoring and conduct of the study will be blinded to which vaccine was administered. Only the unblinded monitor, site personnel performing randomization, preparation and administration of IMP will be unblinded.

Conditions

• Zika Virus Infection

Interventions

Type	Name	Description
BIOLOGICAL	Two MV-ZIKA-RSP vaccinations (high dose)	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)
BIOLOGICAL	Two MV-ZIKA-RSP vaccination (low 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)
BIOLOGICAL	One MV-ZIKA-RSP vaccination (high dose) and one placebo	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
OTHER	Two placebo injection	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

Timeline

• Start date: 2019-08-02
• Primary completion: 2020-01-30
• Completion: 2020-06-10
• First posted: 2019-07-25
• Last updated: 2021-12-06
• Results posted: 2021-12-06

Locations

1 site across 1 country: Austria