The purpose of this study is to compare the safety and effectiveness of four different doses of cytomegalovirus vaccines in healthy adults.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
128
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 μg with alum with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
VBI-1501A: 2.0 μg with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
Vaccine Evaluation Center
Vancouver, British Columbia, Canada
Canadian Center for Vaccinology; IWK Health Centre
Halifax, Nova Scotia, Canada
McGill University Health Centre - Vaccine Study
Pierrefonds, Quebec, Canada
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
Time frame: Day of vaccine administration (days 0, 56, 168) and six subsequent days
Number of Participants With Any Adverse Event
Time frame: Following each of the 3 injections of study vaccine, the occurrence of adverse events was captured during a 28-day follow-up period as well as through Day 336 or early withdrawal.
Number of Participants With Any Serious Adverse Event
Time frame: Through Day 336 or early withdrawal
Number of Participants With Any Hematological or Biochemical Laboratory Abnormality
Blood and urine samples were collected at screening for all evaluations with additional blood samples obtained on Days 28, 56, 84, 168, 196, 280, and 336. The following clinical laboratory evaluations were performed: Biochemistry: alanine aminotransferase; aspartate aminotransferase; creatinine; blood urea nitrogen; Hematology: neutrophils, lymphocytes, eosinophils, hemoglobin, platelet count, white blood cell count; Infection status: HIV, hepatitis B, hepatitis C, and cytomegalovirus; and Urinalysis: blood, glucose, protein.
Time frame: Through Day 336 or early withdrawal
Geometric Mean Titer of Antibody Binding to CMV gB
Time frame: Through Day 336 or early withdrawal
Geometric Mean Titer of Antibody Avidity Index Value Against gB
To measure the avidity of responses against CMV gB protein, a standard ELISA assay using recombinant gB protein which did or did not include treatment with 5M urea for 30 minutes of samples after sera had been incubated with recombinant protein. The reported value, or Avidity Index, represents the percent of signal measured in ELISA after treatment with urea relative to samples not exposed to urea.
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VBI-1501: 1.0 μg without alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
buffer/sucrose used for VBI-1501 suspension- administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168.
Time frame: Through Day 336 or early withdrawal
Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Fibroblast Cells
Time frame: Through Day 196 or early withdrawal
Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells
Time frame: Through Day 336 or early withdrawal