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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.

Tracking Information
First Submitted Date  ICMJE December 15, 2020
First Posted Date  ICMJE December 30, 2020
Last Update Posted Date July 25, 2022
Actual Study Start Date  ICMJE December 14, 2020
Actual Primary Completion Date December 7, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2020)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2020)
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PROtocol for Coxsackievirus VaccinE in Healthy VoluNTteers
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Viral; Infection, Coxsackie(Virus)
Intervention  ICMJE
  • Biological: PRV-101
    Coxsackie Virus B vaccine
  • Other: Placebo
    Placebo
Study Arms  ICMJE
  • Placebo Comparator: Cohort 1, Low Dose, Placebo
    Low dose of placebo by intramuscular injection, 3 doses at 4-week intervals
    Intervention: Other: Placebo
  • Experimental: Cohort 1, Low Dose, PRV-101
    Low dose of PRV-101 by intramuscular injection, 3 doses at 4-week intervals
    Intervention: Biological: PRV-101
  • Placebo Comparator: Cohort 2, High Dose, Placebo
    High dose of placebo by intramuscular injection, 3 doses at 4-week intervals
    Intervention: Other: Placebo
  • Experimental: Cohort 2, High Dose, PRV-101
    High dose of PRV-101 by intramuscular injection, 3 doses at 4-week intervals
    Intervention: Biological: PRV-101
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 27, 2020)
32
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 7, 2021
Actual Primary Completion Date December 7, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04690426
Other Study ID Numbers  ICMJE PRV-101-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Provention Bio, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Provention Bio, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chief Scientific Officer CRST Oy
PRS Account Provention Bio, Inc.
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP