Viral; Infection, Coxsackie(Virus)
Conditions
Keywords
Coxsackie Virus B, vaccine
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.
Interventions
BIOLOGICALPRV-101
Coxsackie Virus B vaccine
OTHERPlacebo
Placebo
Sponsors
Provention Bio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
Countries
Finland
Outcome results
None listed