PROtocol for Coxsackievirus VaccinE in Healthy VoluNTteers

Viral; Infection, Coxsackie(Virus) Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04690426
• Other study ID #: PRV-101-001
• Status: Completed
• Phase: Phase 1
• Start date: December 14, 2020
• Est. completion date: December 7, 2021

Study information

• Verified date: July 2022
• Source: Provention Bio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 7, 2021
• Est. primary completion date: December 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Viral; Infection, Coxsackie(Virus)
• Virus Diseases

Intervention

Biological:
• PRV-101
Coxsackie Virus B vaccine

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Finland	Clinical Research Services Turku (CRST) Oy	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Provention Bio, Inc.

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Throughout the 32 weeks of the study
Secondary	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)	Days 1, 29, and 57 and Weeks 12 and 32
Secondary	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	Days 1, 29 and 57 and weeks 12 and 32