PROtocol for Coxsackievirus VaccinE in Healthy VoluNTteers

Launched by PROVENTION BIO, INC. · Dec 27, 2020

Keywords

ClinConnect Summary

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.

Gender

ALL

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