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

April 16, 2020 updated by: VBI Vaccines Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4H4
        • Vaccine Evaluation Center
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • Canadian Center for Vaccinology; IWK Health Centre
    • Quebec
      • Pierrefonds, Quebec, Canada, H9H 4Y6
        • McGill University Health Centre - Vaccine Study

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VBI-1501A: 0.5µg with adjuvant
0.5µg CMV vaccine with adjuvant
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
Experimental: VBI-1501A: 1.0µg with adjuvant
1.0µg CMV vaccine with adjuvant
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
Experimental: VBI-1501A: 2.0 µg with adjuvant
2.0 µg CMV vaccine with adjuvant
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
Experimental: VBI-1501: 1.0µg without adjuvant
1.0µg CMV vaccine without adjuvant
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
Placebo Comparator: Placebo
Buffer/sucrose used for VBI-1501 suspension
Drug: Placebo
buffer/sucrose used for VBI-1501 suspension- administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
Through Day 336 or early withdrawal
Number of Participants With Any Hematological or Biochemical Laboratory Abnormality
Time Frame: 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.
Through Day 336 or early withdrawal

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geometric Mean Titer of Antibody Binding to CMV gB
Time Frame: Through Day 336 or early withdrawal
Through Day 336 or early withdrawal
Geometric Mean Titer of Antibody Avidity Index Value Against gB
Time Frame: 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.
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
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
Through Day 336 or early withdrawal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VBI Vaccines Inc.

Collaborators

Clinical Trial Data Services, LLC

Investigators

  • Principal Investigator: Joanne Langley, MD, IWK Health Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2016

Primary Completion (Actual)

September 15, 2016

Study Completion (Actual)

August 24, 2017

Study Registration Dates

First Submitted

June 23, 2016

First Submitted That Met QC Criteria

July 5, 2016

First Posted (Estimate)

July 11, 2016

Study Record Updates

Last Update Posted (Actual)

April 20, 2020

Last Update Submitted That Met QC Criteria

April 16, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VBI-1501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cytomegalovirus Infections

Clinical Trials on VBI-1501A 0.5 μg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe