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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02826798
Recruitment Status : Completed
First Posted : July 11, 2016
Results First Posted : April 20, 2020
Last Update Posted : April 20, 2020
Sponsor:
Collaborator:
Clinical Trial Data Services, LLC
Information provided by (Responsible Party):
VBI Vaccines Inc.

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

Condition or disease Intervention/treatment Phase
Cytomegalovirus Infections Drug: VBI-1501A 0.5 μg Drug: VBI-1501A 1.0 μg Drug: VBI-1501A 2.0 μg Drug: VBI-1501 1.0 μg Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 23, 2016
Actual Primary Completion Date : September 15, 2016
Actual Study Completion Date : August 24, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 ]
  2. 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. ]
  3. Number of Participants With Any Serious Adverse Event [ Time Frame: Through Day 336 or early withdrawal ]
  4. 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.


Secondary Outcome Measures :
  1. Geometric Mean Titer of Antibody Binding to CMV gB [ Time Frame: Through Day 336 or early withdrawal ]
  2. 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.

  3. Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Fibroblast Cells [ Time Frame: Through Day 196 or early withdrawal ]
  4. Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells [ Time Frame: Through Day 336 or early withdrawal ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02826798


Locations
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Canada, British Columbia
Vaccine Evaluation Center
Vancouver, British Columbia, Canada, V5Z 4H4
Canada, Nova Scotia
Canadian Center for Vaccinology; IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Quebec
McGill University Health Centre - Vaccine Study
Pierrefonds, Quebec, Canada, H9H 4Y6
Sponsors and Collaborators
VBI Vaccines Inc.
Clinical Trial Data Services, LLC
Investigators
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Principal Investigator: Joanne Langley, MD IWK Health Centre

Publications:
FDA Guidance for industry (Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical studies, September 2007. Available at: http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm091977.pdf.
15. Paneque-Quevedo AA. Inorganic compounds as vaccine adjuvants. Biotecnología Aplicada. 2013;30:250-256.

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Responsible Party: VBI Vaccines Inc.
ClinicalTrials.gov Identifier: NCT02826798    
Other Study ID Numbers: VBI-1501
First Posted: July 11, 2016    Key Record Dates
Results First Posted: April 20, 2020
Last Update Posted: April 20, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by VBI Vaccines Inc.:
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)
Additional relevant MeSH terms:
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Infection
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases