PROtocol for Coxsackievirus VaccinE in Healthy VoluNTteers

NCT04690426 | Completed Phase 1 DMC

• 1 other identifier: PRV-101-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Viral; Infection, Coxsackie(Virus)

Keywords

Coxsackie Virus B, vaccine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Development of neutralizing antibodies to coxsackie B virus (immunogenicity, efficacy)

  Days 1, 29, and 57 and Weeks 12 and 32

• Titer of antibodies to coxsackie B virus (immunogenicity, efficacy)

  Days 1, 29 and 57 and weeks 12 and 32

Study Arms (4)

Cohort 1, Low Dose, Placebo

PLACEBO COMPARATOR

Low dose of placebo by intramuscular injection, 3 doses at 4-week intervals

Other: Placebo

Cohort 1, Low Dose, PRV-101

EXPERIMENTAL

Low dose of PRV-101 by intramuscular injection, 3 doses at 4-week intervals

Biological: PRV-101

Cohort 2, High Dose, Placebo

PLACEBO COMPARATOR

High dose of placebo by intramuscular injection, 3 doses at 4-week intervals

Other: Placebo

Cohort 2, High Dose, PRV-101

EXPERIMENTAL

High dose of PRV-101 by intramuscular injection, 3 doses at 4-week intervals

Biological: PRV-101

Interventions

PRV-101 BIOLOGICAL

Coxsackie Virus B vaccine

Cohort 1, Low Dose, PRV-101; Cohort 2, High Dose, PRV-101

Placebo OTHER

Placebo

Cohort 1, Low Dose, Placebo; Cohort 2, High Dose, Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Provention Bio, Inc.: lead

Study Sites (1)

Clinical Research Services Turku (CRST) Oy

Turku, Finland

Location

Related Publications (1)

• Hyoty H, Kaariainen S, Laiho JE, Comer GM, Tian W, Harkonen T, Lehtonen JP, Oikarinen S, Puustinen L, Snyder M, Leon F, Scheinin M, Knip M, Sanjuan M. Safety, tolerability and immunogenicity of PRV-101, a multivalent vaccine targeting coxsackie B viruses (CVBs) associated with type 1 diabetes: a double-blind randomised placebo-controlled Phase I trial. Diabetologia. 2024 May;67(5):811-821. doi: 10.1007/s00125-024-06092-w. Epub 2024 Feb 19.

  PMID: 38369573 DERIVED

MeSH Terms

Conditions

Coxsackievirus Infections

Condition Hierarchy (Ancestors)

Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Chief Scientific Officer

  CRST Oy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 30, 2020
• Study Start: December 14, 2020
• Primary Completion: December 7, 2021
• Study Completion: December 7, 2021
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)