Safety and Immunogenicity of a Novel Vaccine Formulation MV-ZIKA-RSP (V187-001)
Condition: Zika Virus Infection
MeSH terms: Zika Virus Infection
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Two MV-ZIKA-RSP vaccinations (high dose); Two MV-ZIKA-RSP vaccination (low dose); One MV-ZIKA-RSP vaccination (high dose) and one placebo; Two placebo injection
Intervention type(s): Biological; Biological; Biological; Other
Intervention description(s): In this arm of the study, 14 participants will receive:
V1= day 0; dose vaccination with MV-ZIKA-RSP (high dose).
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:
V1= day 0; dose vaccination with MV-ZIKA-RSP (low dose).
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:
V1= day 0; dose vaccination with MV-ZIKA-RSP (high dose).
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:
V1= day 0; placebo treatment
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
Other intervention name(s): Placebo arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Zika virus; mosquito-borne pathogen; Zika fever