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

NCT02826798 | Completed Phase 1 Results DMC

• 1 other identifier: VBI-1501
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 3

Brief Summary

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

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)

Outcome Measures

Primary Outcomes (4)

• 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

• 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.

  Through Day 336 or early withdrawal

Secondary Outcomes (4)

• 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

• 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

Study Arms (5)

VBI-1501A: 0.5µg with adjuvant

EXPERIMENTAL

0.5µg CMV vaccine with adjuvant

Drug: VBI-1501A 0.5 μg

VBI-1501A: 1.0µg with adjuvant

EXPERIMENTAL

1.0µg CMV vaccine with adjuvant

Drug: VBI-1501A 1.0 μg

VBI-1501A: 2.0 µg with adjuvant

EXPERIMENTAL

2.0 µg CMV vaccine with adjuvant

Drug: VBI-1501A 2.0 μg

VBI-1501: 1.0µg without adjuvant

EXPERIMENTAL

1.0µg CMV vaccine without adjuvant

Drug: VBI-1501 1.0 μg

Placebo

PLACEBO COMPARATOR

Buffer/sucrose used for VBI-1501 suspension

Drug: Placebo

Interventions

VBI-1501A 0.5 μg DRUG

VBI-1501A: 0.5 μg with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168

VBI-1501A: 0.5µg with adjuvant

VBI-1501A 1.0 μg DRUG

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: 1.0µg with adjuvant

VBI-1501A 2.0 μg DRUG

VBI-1501A: 2.0 μg with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168

VBI-1501A: 2.0 µg with adjuvant

VBI-1501 1.0 μg DRUG

VBI-1501: 1.0 μg without alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168

VBI-1501: 1.0µg without adjuvant

Placebo DRUG

buffer/sucrose used for VBI-1501 suspension- administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168.

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VBI Vaccines Inc.: lead
• Clinical Trial Data Services, LLC: collaborator

Study Sites (3)

Vaccine Evaluation Center

Vancouver, British Columbia, V5Z 4H4, Canada

Location

Canadian Center for Vaccinology; IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

McGill University Health Centre - Vaccine Study

Pierrefonds, Quebec, H9H 4Y6, Canada

Location

Related Publications (20)

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  BACKGROUND

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  PMID: 38142214 DERIVED

MeSH Terms

Conditions

Cytomegalovirus Infections; Virus Diseases; Herpesviridae Infections

Condition Hierarchy (Ancestors)

DNA Virus Infections; Infections

Results Point of Contact

• Title: Bebi Yassin-Rajkumar
• Organization: VBI

byassin-rajkumar@vbivaccines.com

613-749-4200

Study Officials

• Joanne Langley, MD

  IWK Health Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: July 11, 2016
• Study Start: June 23, 2016
• Primary Completion: September 15, 2016
• Study Completion: August 24, 2017
• Last Updated: April 20, 2020
• Results First Posted: April 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)