PROtocol for Coxsackievirus VaccinE in Healthy VoluNTteers (PROVENT)

Provention Bio

Status and phase: Completed; Phase 1

Conditions: Viral; Infection, Coxsackie(Virus)

Treatments: Biological: PRV-101; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04690426

PRV-101-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 4 patient groups, including a placebo group

Cohort 1, Low Dose, Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

Cohort 1, Low Dose, PRV-101

Experimental group

Description:

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

Treatment:

Biological: PRV-101

Cohort 2, High Dose, Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

Cohort 2, High Dose, PRV-101

Experimental group

Description:

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

Treatment:

Biological: PRV-101