Status:
COMPLETED
PROtocol for Coxsackievirus VaccinE in Healthy VoluNTteers
Lead Sponsor:
Provention Bio, Inc.
Conditions:
Viral; Infection, Coxsackie(Virus)
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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, i...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2021
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04690426
Start Date
December 14 2020
End Date
December 7 2021
Last Update
July 25 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Research Services Turku (CRST) Oy
Turku, Finland