Back to resultsPROtocol for Coxsackievirus VaccinE in Healthy VoluNTteers (PROVENT)
Primary Purpose
Viral; Infection, Coxsackie(Virus)
Status
Completed
Phase
Phase 1
Locations
Finland
Study Type
Interventional
Intervention
PRV-101
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Viral; Infection, Coxsackie(Virus) focused on measuring Coxsackie Virus B, vaccine
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
Sites / Locations
- Clinical Research Services Turku (CRST) Oy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Arm Label
Cohort 1, Low Dose, Placebo
Cohort 1, Low Dose, PRV-101
Cohort 2, High Dose, Placebo
Cohort 2, High Dose, PRV-101
Arm Description
Low dose of placebo by intramuscular injection, 3 doses at 4-week intervals
Low dose of PRV-101 by intramuscular injection, 3 doses at 4-week intervals
High dose of placebo by intramuscular injection, 3 doses at 4-week intervals
High dose of PRV-101 by intramuscular injection, 3 doses at 4-week intervals
Outcomes
Primary Outcome Measures
Incidence and severity of treatment-emergent adverse events (safety and tolerability)
Adverse events will be assessed by frequency and criteria for severity (mild, moderate or severe)
Secondary Outcome Measures
Development of neutralizing antibodies to coxsackie B virus (immunogenicity, efficacy)
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)
Mean and peak geometric mean serum IgG titers of antibodies against any of the coxsackie B virus strains, measured by ELISA
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04690426
Brief Title
PROtocol for Coxsackievirus VaccinE in Healthy VoluNTteers
Acronym
PROVENT
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
December 14, 2020 (Actual)
Primary Completion Date
December 7, 2021 (Actual)
Study Completion Date
December 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Provention Bio, Inc.
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Viral; Infection, Coxsackie(Virus)
Keywords
Coxsackie Virus B, vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1, Low Dose, Placebo
Arm Type
Placebo Comparator
Arm Description
Low dose of placebo by intramuscular injection, 3 doses at 4-week intervals
Arm Title
Cohort 1, Low Dose, PRV-101
Arm Type
Experimental
Arm Description
Low dose of PRV-101 by intramuscular injection, 3 doses at 4-week intervals
Arm Title
Cohort 2, High Dose, Placebo
Arm Type
Placebo Comparator
Arm Description
High dose of placebo by intramuscular injection, 3 doses at 4-week intervals
Arm Title
Cohort 2, High Dose, PRV-101
Arm Type
Experimental
Arm Description
High dose of PRV-101 by intramuscular injection, 3 doses at 4-week intervals
Intervention Type
Biological
Intervention Name(s)
PRV-101
Intervention Description
Coxsackie Virus B vaccine
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Incidence and severity of treatment-emergent adverse events (safety and tolerability)
Description
Adverse events will be assessed by frequency and criteria for severity (mild, moderate or severe)
Time Frame
Throughout the 32 weeks of the study
Secondary Outcome Measure Information:
Title
Development of neutralizing antibodies to coxsackie B virus (immunogenicity, efficacy)
Description
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)
Time Frame
Days 1, 29, and 57 and Weeks 12 and 32
Title
Titer of antibodies to coxsackie B virus (immunogenicity, efficacy)
Description
Mean and peak geometric mean serum IgG titers of antibodies against any of the coxsackie B virus strains, measured by ELISA
Time Frame
Days 1, 29 and 57 and weeks 12 and 32
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Scientific Officer
Organizational Affiliation
CRST Oy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Services Turku (CRST) Oy
City
Turku
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PROtocol for Coxsackievirus VaccinE in Healthy VoluNTteers
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