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

Phase 1

Completed

Interventions: Drug: VBI-1501A 2.0 μg
Drug: VBI-1501A 0.5 μg
Drug: VBI-1501A 1.0 μg
Drug: VBI-1501 1.0 μg
Drug: Placebo

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Generally healthy adult female and male 18 to 40 years of age, inclusive;
Serologically confirmed to be CMV seronegative at screening;
Female volunteers must agree to use an adequate contraception method as deemed appropriate by the investigator
Sign an informed consent document indicating understanding of the purpose and procedures required for the study and willingness to participate in the study

Exclusion Criteria

History of or current clinically significant medical illness or any other illness that in the opinion of the investigator interferes with the interpretation of the study results
Clinically significant abnormal physical examination, vital signs, or clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening as determined by the investigator
Previous receipt of any cytomegalovirus vaccine
History of allergic reactions or anaphylactic reaction to any vaccine component
Pregnant or breastfeeding or plans to conceive from two weeks before the study start through six months after the last dose of study vaccine
Known or suspected impairment of immunological function, including but not limited to autoimmune diseases, splenectomy, or HIV/AIDS
Chronic administration (defined as more than 14 days in total) of immune-suppressive or other immune-modifying drug with six months prior to the product dose (for corticosteroids, this is defined as prednisone ≥20 mg/day or equivalent). Inhaled and topical steroids are allowed
Participation in another clinical study within 30 days or plans to participate in another treatment based clinical study during the conduct of the present study
Any skin abnormality or tattoo that would limit post-vaccination injection site assessment
Any history of cancer requiring chemotherapy or radiation within 5 years of randomization or current disease
Are family members of study center staff

Arm && Interventions

Group	Intervention	Description
VBI-1501A: 2.0 µg with adjuvant	VBI-1501A 2.0 μg	2.0 µg CMV vaccine with adjuvant
VBI-1501A: 0.5µg with adjuvant	VBI-1501A 0.5 μg	0.5µg CMV vaccine with adjuvant
VBI-1501A: 1.0µg with adjuvant	VBI-1501A 1.0 μg	1.0µg CMV vaccine with adjuvant
VBI-1501: 1.0µg without adjuvant	VBI-1501 1.0 μg	1.0µg CMV vaccine without adjuvant
Placebo	Placebo	Buffer/sucrose used for VBI-1501 suspension

Primary Outcome Measures

Name	Time	Method
Number of Participants With Any Hematological or Biochemical Laboratory Abnormality	Through Day 336 or early withdrawal	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.
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period	Day of vaccine administration (days 0, 56, 168) and six subsequent days
Number of Participants With Any Adverse Event	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	Through Day 336 or early withdrawal

Secondary Outcome Measures

Name	Time	Method
Geometric Mean Titer of Antibody Binding to CMV gB	Through Day 336 or early withdrawal
Geometric Mean Titer of Antibody Avidity Index Value Against gB	Through Day 336 or early withdrawal	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.
Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Fibroblast Cells	Through Day 196 or early withdrawal
Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells	Through Day 336 or early withdrawal

Locations (3): Canadian Center for Vaccinology; IWK Health Centre
🇨🇦
Halifax, Nova Scotia, Canada
Vaccine Evaluation Center
🇨🇦
Vancouver, British Columbia, Canada
McGill University Health Centre - Vaccine Study
🇨🇦
Pierrefonds, Quebec, Canada