Clinical trial NCT02826798: Study to Evaluate Safety, Tolerability, and Immunogenicity of Candidate Human Cytomegalovirus Vaccine in Healthy Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cytomegalovirus Infections
Keywords: VBI-1501A
VBI-1501
prophylactic vaccine
virus diseases
cytomegalovirus (CMV)
cytomegalovirus infections
cytomegalovirus vaccines
Herpesviridae Infections
Phase 1
Human Herpesvirus 5 (HHV5)
Vaccines, virus-like particle (VLP)
enveloped virus-like particle (eVLP)
Lead sponsor: VBI Vaccines Inc.
Sponsor class: INDUSTRY
Collaborators: name: Clinical Trial Data Services, LLC
First posted: 2016-07-11
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Generally healthy adult female and male 18 to 40 years of age, inclusive;
2. Serologically confirmed to be CMV seronegative at screening;
3. Female volunteers must agree to use an adequate contraception method as deemed appropriate by the investigator
4. 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:

1. 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
2. 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
3. Previous receipt of any cytomegalovirus vaccine
4. History of allergic reactions or anaphylactic reaction to any vaccine component
5. Pregnant or breastfeeding or plans to conceive from two weeks before the study start through six months after the last dose of study vaccine
6. Known or suspected impairment of immunological function, including but not limited to autoimmune diseases, splenectomy, or HIV/AIDS
7. 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
8. 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
9. Any skin abnormality or tattoo that would limit post-vaccination injection site assessment
10. Any history of cancer requiring chemotherapy or radiation within 5 years of randomization or current disease
11. Are family members of study center staff

Primary outcomes:
measure: Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
timeFrame: Day of vaccine administration (days 0, 56, 168) and six subsequent days
measure: Number of Participants With Any Adverse Event
timeFrame: 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.
measure: Number of Participants With Any Serious Adverse Event
timeFrame: Through Day 336 or early withdrawal
measure: Number of Participants With Any Hematological or Biochemical Laboratory Abnormality
timeFrame: Through Day 336 or early withdrawal
Secondary outcomes:
measure: Geometric Mean Titer of Antibody Binding to CMV gB
timeFrame: Through Day 336 or early withdrawal
measure: Geometric Mean Titer of Antibody Avidity Index Value Against gB
timeFrame: Through Day 336 or early withdrawal
measure: Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Fibroblast Cells
timeFrame: Through Day 196 or early withdrawal
measure: Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells
timeFrame: Through Day 336 or early withdrawal
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vaccine Evaluation Center
state: British Columbia
city: Halifax
country: Canada
facility: Canadian Center for Vaccinology; IWK Health Centre
state: Nova Scotia
city: Pierrefonds
country: Canada
facility: McGill University Health Centre - Vaccine Study
state: Quebec
Study officials:
affiliation: IWK Health Centre
name: Joanne Langley, MD
role: PRINCIPAL_INVESTIGATOR
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