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PROtocol for Coxsackievirus VaccinE in Healthy VoluNTteers (PROVENT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04690426
Recruitment Status : Completed
First Posted : December 30, 2020
Last Update Posted : July 25, 2022
Sponsor:
Information provided by (Responsible Party):
Provention Bio, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Viral; Infection, Coxsackie(Virus) Biological: PRV-101 Other: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : December 14, 2020
Actual Primary Completion Date : December 7, 2021
Actual Study Completion Date : December 7, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Cohort 1, Low Dose, Placebo
Low dose of placebo by intramuscular injection, 3 doses at 4-week intervals
Other: Placebo
Placebo

Experimental: Cohort 1, Low Dose, PRV-101
Low dose of PRV-101 by intramuscular injection, 3 doses at 4-week intervals
Biological: PRV-101
Coxsackie Virus B vaccine

Placebo Comparator: Cohort 2, High Dose, Placebo
High dose of placebo by intramuscular injection, 3 doses at 4-week intervals
Other: Placebo
Placebo

Experimental: Cohort 2, High Dose, PRV-101
High dose of PRV-101 by intramuscular injection, 3 doses at 4-week intervals
Biological: PRV-101
Coxsackie Virus B vaccine




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04690426


Locations
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Finland
Clinical Research Services Turku (CRST) Oy
Turku, Finland
Sponsors and Collaborators
Provention Bio, Inc.
Investigators
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Principal Investigator: Chief Scientific Officer CRST Oy
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Responsible Party: Provention Bio, Inc.
ClinicalTrials.gov Identifier: NCT04690426    
Other Study ID Numbers: PRV-101-001
First Posted: December 30, 2020    Key Record Dates
Last Update Posted: July 25, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Provention Bio, Inc.:
Coxsackie Virus B, vaccine
Additional relevant MeSH terms:
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Virus Diseases
Coxsackievirus Infections
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections