PROtocol for Coxsackievirus VaccinE in Healthy VoluNTteers (PROVENT)

• ClinicalTrials.gov Identifier: NCT04690426
• Recruitment Status: Completed
• First Posted: December 30, 2020
• Last Update Posted: July 25, 2022
• Sponsor: Provention Bio, Inc.
• Information provided by (Responsible Party): Provention Bio, Inc.

Tracking Information

• First Submitted Date: December 15, 2020
• First Posted Date: December 30, 2020
• Last Update Posted Date: July 25, 2022
• Actual Study Start Date: December 14, 2020
• Actual Primary Completion Date: December 7, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: PROtocol for Coxsackievirus VaccinE in Healthy VoluNTteers
• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Viral; Infection, Coxsackie(Virus)

Intervention

• Biological: PRV-101
  Coxsackie Virus B vaccine
• Other: Placebo
  Placebo

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 27, 2020): 32
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 7, 2021
• Actual Primary Completion Date: December 7, 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Finland

Administrative Information

• NCT Number: NCT04690426
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Provention Bio, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Provention Bio, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Chief Scientific Officer; CRST Oy

• PRS Account: Provention Bio, Inc.
• Verification Date: July 2022