PROtocol for Coxsackievirus VaccinE in Healthy VoluNTteers

Phase 1

Completed

• Conditions: Viral; Infection, Coxsackie(Virus)
• Interventions: Biological: PRV-101; Other: Placebo

• Registration Number: NCT04690426
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2020-12-14
• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2020-12-27
• Study First Posted: 2020-12-30
• Primary Completion: 2021-12-07
• Study Completion: 2021-12-07
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-20
• Last Update Posted: 2022-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1, Low Dose, PRV-101	PRV-101	Low dose of PRV-101 by intramuscular injection, 3 doses at 4-week intervals
Cohort 1, Low Dose, Placebo	Placebo	Low dose of placebo by intramuscular injection, 3 doses at 4-week intervals
Cohort 2, High Dose, Placebo	Placebo	High dose of placebo by intramuscular injection, 3 doses at 4-week intervals
Cohort 2, High Dose, PRV-101	PRV-101	High dose of PRV-101 by intramuscular injection, 3 doses at 4-week intervals

Primary Outcome Measures

Name	Time	Method
Incidence and severity of treatment-emergent adverse events (safety and tolerability)	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

Name	Time	Method
Titer of antibodies to coxsackie B virus (immunogenicity, efficacy)	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
Development of neutralizing antibodies to coxsackie B virus (immunogenicity, efficacy)	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)

Trial Locations

Locations (1)

Clinical Research Services Turku (CRST) Oy; 🇫🇮 Turku, Finland