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PROtocol for Coxsackievirus VaccinE in Healthy VoluNTteers

NCT04690426 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-07-25

No results posted yet for this study

Summary

Phase 1, first-in-human, randomized, double-blind, placebo-controlled, multiple-dose-escalation study to evaluate the safety, tolerability and immunogenicity of PRV-101, a coxsackie virus B vaccine, in healthy volunteers.

Conditions

  • Viral; Infection, Coxsackie(Virus)

Interventions

BIOLOGICAL

PRV-101

Coxsackie Virus B vaccine

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Provention Bio, Inc.

    lead INDUSTRY

Principal Investigators

  • Chief Scientific Officer · CRST Oy

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-14
Primary Completion
2021-12-07
Completion
2021-12-07

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04690426 on ClinicalTrials.gov