NCT02826798

Study to Evaluate Safety, Tolerability, and Immunogenicity of Candidate Human Cytomegalovirus Vaccine in Healthy Adults

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: VBI Vaccines Inc. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This study is designed to assess safety and immunogenicity of four dose formulations of cytomegalovirus (CMV) vaccine (0.5 μg gB content with aluminum phosphate (alum), 1.0 μg glycoprotein B (gB) content with alum, 2.0 μg gB content with alum, or 1.0 μg gB content (without alum) as compared with placebo in approximately 125 healthy CMV-seronegative volunteer participants between 18 and 40 years of age.

Conditions

• Cytomegalovirus Infections

Interventions

Type	Name	Description
DRUG	VBI-1501A 0.5 μg	VBI-1501A: 0.5 μg with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
DRUG	VBI-1501A 1.0 μg	VBI-1501A: 1.0 μg with alum with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
DRUG	VBI-1501A 2.0 μg	VBI-1501A: 2.0 μg with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
DRUG	VBI-1501 1.0 μg	VBI-1501: 1.0 μg without alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
DRUG	Placebo	buffer/sucrose used for VBI-1501 suspension- administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168.

Timeline

• Start date: 2016-06-23
• Primary completion: 2016-09-15
• Completion: 2017-08-24
• First posted: 2016-07-11
• Last updated: 2020-04-20
• Results posted: 2020-04-20

Locations

3 sites across 1 country: Canada