Clinical trial NCT04690426: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Viral; Infection, Coxsackie(Virus)
Keywords: Coxsackie Virus B, vaccine
Lead sponsor: Provention Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-30
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence and severity of treatment-emergent adverse events (safety and tolerability)
timeFrame: Throughout the 32 weeks of the study
Secondary outcomes:
measure: Development of neutralizing antibodies to coxsackie B virus (immunogenicity, efficacy)
timeFrame: Days 1, 29, and 57 and Weeks 12 and 32
measure: Titer of antibodies to coxsackie B virus (immunogenicity, efficacy)
timeFrame: Days 1, 29 and 57 and weeks 12 and 32
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Clinical Research Services Turku (CRST) Oy
Study officials:
affiliation: CRST Oy
name: Chief Scientific Officer
role: PRINCIPAL_INVESTIGATOR
References: