PROtocol for Coxsackievirus VaccinE in Healthy VoluNTteers (PROVENT)

July 20, 2022 updated by: Provention Bio, Inc.

A 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 (CVB) Vaccine, in Healthy Adult Subjects

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.

Study Overview

Status

Completed

Detailed Description

Thirty two healthy adult subjects will be enrolled into 2 dose cohorts (low-dose and high-dose cohorts, 16 subjects per cohort) and will be randomized in a double-blind manner to PRV-101 or placebo in a 3:1 ratio. Each subject will receive up to 3 administrations of the study drug (PRV-101 or placebo) at 4-week intervals and will be followed for 24 weeks after the final dose. Each cohort will start with a sentinel dosing group (2 subjects). Cohort 2 will commence after safety data from the first 2 doses from all Cohort 1 participants are reviewed.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Turku, Finland
        • Clinical Research Services Turku (CRST) Oy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adults, males and females, ages 18 to 45 yrs, with BMI 19 to 30 kg/m2
  • Women of childbearing potential must have negative pregnancy test and agree to use an acceptable method of highly effective contraceptive
  • Men must either have a vasectomy or agree to use highly effective contraception

Exclusion Criteria:

  • Prior or current clinically significant medical illness or disorder
  • Has celiac disease or type 1 diabetes or related autoantibodies
  • Has active acute or chronic/latent infection, or history of recent serious infection
  • Recent acute illness or recent major illness, hospitalization or surgery
  • Recent history of alcohol or drug abuse
  • Received an experimental antibody or biologic therapy in last 6 months
  • Received live, inactivated or subunit virus vaccine or a bacterial vaccine within last 4 weeks
  • Intolerance or hypersensitivity to vaccines or vaccine components or has a drug or food allergy or allergic disease requiring medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Cohort 1, Low Dose, Placebo
Low dose of placebo by intramuscular injection, 3 doses at 4-week intervals
Placebo
Experimental: Cohort 1, Low Dose, PRV-101
Low dose of PRV-101 by intramuscular injection, 3 doses at 4-week intervals
Coxsackie Virus B vaccine
Placebo Comparator: Cohort 2, High Dose, Placebo
High dose of placebo by intramuscular injection, 3 doses at 4-week intervals
Placebo
Experimental: Cohort 2, High Dose, PRV-101
High dose of PRV-101 by intramuscular injection, 3 doses at 4-week intervals
Coxsackie Virus B vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of treatment-emergent adverse events (safety and tolerability)
Time Frame: Throughout the 32 weeks of the study
Adverse events will be assessed by frequency and criteria for severity (mild, moderate or severe)
Throughout the 32 weeks of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of neutralizing antibodies to coxsackie B virus (immunogenicity, efficacy)
Time Frame: Days 1, 29, and 57 and Weeks 12 and 32
Proportion of responders (ie, those that seroconvert or have at least a 4-fold increase in neutralizing antibody titers to any of the coxsackie B virus strains as measured by plaque reduction assay using serial serum dilutions)
Days 1, 29, and 57 and Weeks 12 and 32
Titer of antibodies to coxsackie B virus (immunogenicity, efficacy)
Time Frame: Days 1, 29 and 57 and weeks 12 and 32
Mean and peak geometric mean serum IgG titers of antibodies against any of the coxsackie B virus strains, measured by ELISA
Days 1, 29 and 57 and weeks 12 and 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Chief Scientific Officer, CRST Oy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2020

Primary Completion (Actual)

December 7, 2021

Study Completion (Actual)

December 7, 2021

Study Registration Dates

First Submitted

December 15, 2020

First Submitted That Met QC Criteria

December 27, 2020

First Posted (Actual)

December 30, 2020

Study Record Updates

Last Update Posted (Actual)

July 25, 2022

Last Update Submitted That Met QC Criteria

July 20, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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