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

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

August 2, 2019

Primary Completion Date

January 30, 2020

Study Completion Date

June 10, 2020

Conditions
Zika Virus Infection
Interventions
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"

Trial Locations (1)

1090

Institute of Specific Prophylaxis and Tropical Medicine, Vienna

All Listed Sponsors
lead

Themis Bioscience GmbH

INDUSTRY

NCT04033068 - Safety and Immunogenicity of a Novel Vaccine Formulation MV-ZIKA-RSP (V187-001) | Biotech Hunter | Biotech Hunter