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Safety, Tolerability, and Immunogenicity of the COVID-19 Vaccine Candidate (VBI-2902a)

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: NCT04773665
Recruitment Status : Active, not recruiting
First Posted : February 26, 2021
Last Update Posted : April 21, 2021
Sponsor:
Information provided by (Responsible Party):
VBI Vaccines Inc.

Brief Summary:
VBI-2902a is an investigational vaccine candidate that uses enveloped virus-like particle (eVLP) expression of a modified version of the SARS-CoV-2 spike (S) glycoprotein and is designed to induce neutralizing antibody and cell-mediated immune responses against the SARS-CoV-2 spike protein. VBI-2902a with up to 10μg spike (S) protein content and aluminum phosphate adjuvant is delivered by intramuscular (IM) injection. The Phase 1 / 2 study will evaluate the safety, tolerability and immunogenicity of VBI-2902a at one- and two-dose regimens and two dose levels (5 μg and 10 μg of S protein) as compared to placebo (saline solution) in healthy adults 18 years of age and above.

Condition or disease Intervention/treatment Phase
Covid19 Biological: VBI-2902a Biological: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 780 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: This is an observer-blinded study. Both participants and the study center staff performing outcome measurement are blinded; vaccines will be administered by qualified unblinded study personnel who have no other role in the study.
Primary Purpose: Prevention
Official Title: A Phase 1/2, Randomized, Observer-Blind, Dose-Escalation, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of the COVID-19 (SARS-CoV-2) Vaccine Candidate (VBI-2902a) in Healthy Adults
Actual Study Start Date : March 15, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Arm Intervention/treatment
Experimental: Phase 1 -Group G1
20 participants age 18-54 will receive VBI-2902a at a dose of 5 μg of S protein at Day 1 and placebo at Day 28
Biological: VBI-2902a
VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant

Experimental: Phase 1 -Group G2
20 participants age 18-54 will receive VBI-2902a at a dose of 5 μg of S protein at Days 1 and 28
Biological: VBI-2902a
VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant

Placebo Comparator: Phase 1 -Group G3
20 participants age 18-54 will receive placebo at Days 1 and 28
Biological: Placebo
0.9% sodium chloride

Experimental: Phase 2, Part 2.1-Group G4
20 participants age 18-54 will receive VBI-2902a at a dose of 10 μg of S protein at Day 1 and placebo at Day 28
Biological: VBI-2902a
VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant

Experimental: Phase 2, Part 2.1-Group G5
20 participants age 18-54 will receive VBI-2902a at a dose of 10 μg of S protein at Days 1 and 28
Biological: VBI-2902a
VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant

Placebo Comparator: Phase 2, Part 2.1-Group G6
20 participants age 18-54 will receive placebo at Days 1 and 28
Biological: Placebo
0.9% sodium chloride

Experimental: Phase 2, Part 2.1-Group G7
20 participants age 55-65 will receive VBI-2902a at a dose of 5 μg of S protein at Days 1 and 28
Biological: VBI-2902a
VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant

Experimental: Phase 2, Part 2.1-Group G8
20 participants age 55-65 will receive VBI-2902a at a dose of 10 μg of S protein at Days 1 and 28
Biological: VBI-2902a
VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant

Placebo Comparator: Phase 2, Part 2.1-Group G9
20 participants age 55-65 will receive placebo at Days 1 and 28
Biological: Placebo
0.9% sodium chloride

Experimental: Phase 2, Part 2.2-Group G10
100 participants age 18-54 will receive the selected dose of VBI-2902a at Days 1 and 28
Biological: VBI-2902a
VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant

Experimental: Phase 2, Part 2.2-Group G11
100 participants age 55-65 will receive the selected dose of VBI-2902a at Days 1 and 28
Biological: VBI-2902a
VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant

Experimental: Phase 2, Part 2.2-Group G12
100 participants age >65 will receive the selected dose of VBI-2902a at Days 1 and 28
Biological: VBI-2902a
VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant

Placebo Comparator: Phase 2, Part 2.2-Group G13
100 participants age 18-54 will receive placebo at Days 1 and 28
Biological: Placebo
0.9% sodium chloride

Placebo Comparator: Phase 2, Part 2.2-Group G14
100 participants age 55-65 will receive placebo at Days 1 and 28
Biological: Placebo
0.9% sodium chloride

Placebo Comparator: Phase 2, Part 2.2-Group G15
100 participants age >65 will receive placebo at Days 1 and 28
Biological: Placebo
0.9% sodium chloride




Primary Outcome Measures :
  1. Rate and severity of local and systemic solicited adverse events [ Time Frame: Through study completion, an average of 1 year ]
  2. Rate and severity of unsolicited adverse events [ Time Frame: During 28 days after each study vaccination ]
  3. Rate and severity of medically attended adverse events [ Time Frame: Through study completion, an average of 1 year ]
  4. Rate of serious adverse events [ Time Frame: Through study completion, an average of 1 year ]
  5. Adverse events leading to discontinuation of study vaccination [ Time Frame: Through study completion, an average of 1 year ]
  6. Adverse events leading to study discontinuation [ Time Frame: Through study completion, an average of 1 year ]
  7. Rate and severity of laboratory abnormalities (hematology, biochemistry, urinalysis) [ Time Frame: Through study completion, an average of 1 year ]

Secondary Outcome Measures :
  1. Geometric Mean Titer (GMT) and the geometric mean fold increase in serum virus-neutralizing activity in a subset of participants post-vaccination over baseline [ Time Frame: Study Day 56 ]
  2. GMT and the geometric mean fold increase in serum receptor binding domain (RBD) antibody titers measured by ELISA post-vaccination over baseline [ Time Frame: Study Day 56 ]
  3. GMT and the geometric mean fold increase in serum virus-neutralizing activity in a subset of participants post-vaccination over baseline [ Time Frame: Days 7, 28, 35, 56 ]
  4. GMT and the geometric mean fold increase in serum RBD antibody titers measured by ELISA post-vaccination over baseline [ Time Frame: Days 7, 28, 35, 56 ]
  5. GMT and the geometric mean fold increase in serum spike protein antibody binding titers measured by ELISA post-vaccination over baseline [ Time Frame: Days 7, 28, 35, 56 ]


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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

To be eligible for the study, each participant must satisfy all of the following criteria:

  1. Healthy female and male participants 18 years of age and older
  2. If female:

    1. is of childbearing potential and must have a negative pregnancy test prior to study vaccinations and agree to use an effective method of birth control as deemed appropriate by the investigator (e.g., hormonal contraceptive, barrier contraceptive with additional spermicide, or an intrauterine device) beginning >30 days prior to the first study vaccine administration and continuing until the end of the study. OR
    2. is not of childbearing potential, defined as postmenopausal (12 months with no menses without an alternative medical cause) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
  3. Sign an informed consent document indicating understanding of the purpose of and procedures required for the study and willingness to participate in the study.

Exclusion Criteria

Participants with any of the following criteria will be excluded:

  1. Previous clinical or laboratory diagnosis of COVID19 or SARS-CoV-2 infection or positive nucleic acid amplification test (NAAT) / reverse transcriptase-PCR (RT-PCR) or Rapid Antigen test for SARS-CoV-2 at screening.
  2. Previous receipt of an experimental SARS-CoV-2 (COVID-19) vaccine.
  3. Individuals with chronic medical conditions, including any of the following:

    1. Diabetes mellitus Type 1 or Type 2
    2. Chronic pulmonary disease (e.g., COPD or Asthma)
    3. Hypertension (e.g., systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg)
    4. Chronic kidney disease (e.g., glomerular filtration rate (GFR) <60 mL/min/1.73 m2)
    5. Chronic liver disease
    6. Obesity (e.g., BMI >30 kg/m2)
  4. Any history of cancer requiring chemotherapy or radiation within 5 years.
  5. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  6. Known or suspected impairment of immunological function, including but not limited to autoimmune diseases:

    1. autoimmune diseases (e.g. multiple sclerosis, type 1 diabetes, myasthenia gravis, Crohn disease and other inflammatory bowel diseases, celiac disease, systemic lupus erythematosus, scleroderma, including diffuse systemic form and CREST syndrome, systemic sclerosis, dermatomyositis polymyositis, rheumatoid arthritis, juvenile idiopathic arthritis, autoimmune thyroiditis -including Hashimoto thyroiditis, Grave's or Basedow's disease, immune thrombocytopenic purpura, autoimmune hemolytic anemia, autoimmune hepatitis, psoriasis, vitiligo, vasculitis, Guillain-Barré syndrome, Transverse myelitis, Addison's disease, Bell's Palsy and Alopecia Areata);
    2. secondary immunodeficiency disorders (e.g., Acquired Immunodeficiency Syndrome caused by Human Immunodeficiency Virus infection (HIV/AIDS), solid organ transplant, splenectomy);
    3. primary immunodeficiency disorders (e.g., common variable immune deficiency (CVID), Defective phagocytic cell function and neutropenia syndromes, complement deficiency).
  7. History of allergic reactions or anaphylactic reaction to any vaccine component.
  8. Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
  9. Pregnant or breastfeeding or plans to conceive from 2 weeks before the study until the end of study.
  10. Clinically significant abnormal physical examination, vital signs, or clinically significant abnormal values for hematology, serum chemistry or urinalysis at screening as determined by the investigator.
  11. Any laboratory test abnormality that would be considered of Grade 1 severity or above (as per FDA grading guidelines) and is considered as clinically significant by the investigator. Grade 2 severity or above is exclusionary, regardless of clinical assessment.
  12. Has received blood products or immunoglobulin within 90 days of enrollment or is likely to require blood products during the study period.
  13. Chronic administration (defined as more than 14 days in total) of immune suppressive or other immune-modifying drug within 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.
  14. Immunization with attenuated vaccines (e.g., MMR) within 4 weeks prior to enrollment.
  15. Immunization with inactivated vaccines (e.g., influenza) within 2 weeks prior to enrollment.
  16. Participation in another clinical study within 30 days.
  17. Any skin abnormality or tattoo that would limit post-vaccination injection site assessment.
  18. Family members of study site personnel.

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): NCT04773665


Locations
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Canada, Nova Scotia
Canadian Center for Vaccinology
Halifax, Nova Scotia, Canada
Canada, Ontario
Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
LMC Manna - Bayview CPU
Toronto, Ontario, Canada, M4G 3E8
Manna Toronto
Toronto, Ontario, Canada
Canada, Quebec
Manna Montreal
Montreal, Quebec, Canada, H9R 4S3
Manna Research Quebec
Quebec City, Quebec, Canada
Sponsors and Collaborators
VBI Vaccines Inc.
Investigators
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Principal Investigator: Joanne M Langley, MD Canadian Center for Vaccinology
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Responsible Party: VBI Vaccines Inc.
ClinicalTrials.gov Identifier: NCT04773665    
Other Study ID Numbers: VBI-2902a-CT01
First Posted: February 26, 2021    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by VBI Vaccines Inc.:
enveloped virus-like particle (eVLP)
SARS-CoV-2 spike
neutralizing antibody
cell-mediated immune responses
receptor binding domain