CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 128 enrolled
Drug / intervention
VBI-1501A 0.5 μg +4 moredrug
Likely dose
VBI-1501A 0.5 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02826798
NCT02826798Phase 1Completed

A Phase 1 Randomized, Observer-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Candidate Human Cytomegalovirus Vaccine (VBI-1501) in Healthy Adults

VBI Vaccines Inc.·interventional·Posted Jul 11, 2016·Updated Apr 20, 2020

In Brief

A Phase 1 clinical trial evaluating VBI-1501A 0.5 μg, VBI-1501A 1.0 μg, and 3 other interventions for Cytomegalovirus Infections. Completed, enrolled 128 participants across 3 sites.

Detailed Summary

The purpose of this study is to compare the safety and effectiveness of four different doses of cytomegalovirus vaccines in healthy adults.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 11, 2016
Enrollment StartJun 23, 2016
Primary CompletionSep 15, 2016
Study CompletionAug 24, 2017
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 10.0 years ago

Interventions

VBI-1501A 0.5 μgdrug

VBI-1501A: 0.5 μg with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168

VBI-1501A 1.0 μgdrug

VBI-1501A: 1.0 μg with alum with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168

VBI-1501A 2.0 μgdrug

VBI-1501A: 2.0 μg with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168

VBI-1501 1.0 μgdrug

VBI-1501: 1.0 μg without alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168

Placebodrug

buffer/sucrose used for VBI-1501 suspension- administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168.