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Safety, Tolerability, and Immunogenicity of the COVID-19 Vaccine Candidates VBI-2902a and VBI-2905a

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 : July 21, 2022
Sponsor:
Information provided by (Responsible Party):
VBI Vaccines Inc.

Brief Summary:

VBI-2902a and VBI-2905a are investigational vaccine candidates that use enveloped virus-like particle (eVLP) expression of a modified version of the SARS-CoV-2 spike (S) glycoprotein and are designed to induce neutralizing antibody and cell-mediated immune responses against the SARS-CoV-2 spike protein. VBI-2902a expresses the spike protein of SARS-CoV-2 Wuhan isolate (the first virus variant isolated in 2019 in Wuhan, China), while VBI-2905a expresses the spike protein of SARS-CoV-2 variant Beta (B.1.351 variant, first isolated in 2020 in South Africa).

The Phase 1a portion of this study tests one- and two-dose regimens of VBI- 2902a with 5 μg S protein content and aluminum phosphate (alum) adjuvant or placebo delivered by intramuscular (IM) injection. The Phase 1b portion of the study tests a one-dose regimen of VBI-2905a with 5 μg S protein content and alum adjuvant or placebo delivered by IM injection in participants previously vaccinated with an authorized mRNA COVID-19 vaccine.


Condition or disease Intervention/treatment Phase
Covid19 Biological: VBI-2902a Biological: Placebo Biological: VBI-2905a Phase 1

Detailed Description:

Phase 1a:

The primary objective is to evaluate the safety and tolerability of VBI-2902a containing 5 μg of S protein in one- or two-dose regimens in healthy adults of 18-54 years of age.

The secondary objective is to evaluate the immunogenicity of VBI-2902a containing 5 μg of S protein in one- or two-dose regimens in healthy adults 18-54 years of age.

  • Group G1 - 20 participants will receive VBI-2902a at a dose of 5 μg of S protein at Day 1 and placebo at Day 28.
  • Group G2 - 20 participants will receive VBI-2902a at a dose of 5 μg of S protein at Days 1 and 28.
  • Group G3 - 20 participants will receive placebo at Days 1 and 28.

An Independent Data Safety Monitoring Board (DSMB) will review blinded safety data (reactogenicity, adverse events (AEs) and safety laboratory assessments) at Day 7 after the first vaccination. The second vaccination will only be given if the DSMB confirms that Day 7 safety is acceptable and that stopping rules were not met. The DSMB will further review blinded post-vaccination safety through Day 35, 7 days after the second vaccination and through Day 56, 28 days after the second vaccination. The study will be unblinded following DSMB review of safety data collected through Day 56. Study participants will continue with study visits as planned up to 12 months of follow up after the first dose of study vaccine.

Phase 1b:

The primary objective is to evaluate the safety and tolerability of a one-dose regimen of VBI-2905a at a 5 μg dose level of S protein in healthy adults (age 18-54 years) who had been previously vaccinated with mRNA vaccines.

The secondary objective is to evaluate the immunogenicity of a one-dose regimen of VBI-2905a at a 5 μg dose level of S protein in healthy adults (age 18-54 years) who had been previously vaccinated with mRNA vaccines.

A total of 54 healthy adults, age 18-54 years, with no history of clinical or laboratory diagnosis of SARS-CoV- 2 infection or COVID-19 illness, will be enrolled in the Phase 1b part of the study. All participants in Phase 1b will have been previously vaccinated with an authorized mRNA COVID-19 vaccine, including the second dose administered at least 4 months prior to enrollment, will be randomized at a 1:1 ratio to receive, in a blinded fashion, one dose of VBI-2905a or placebo:

  • Group G4 - 27 participants will receive VBI-2905a at a dose of 5 μg of S protein at Day 1
  • Group G5 - 27 participants will receive placebo at Day 1

The DSMB will review blinded post-vaccination safety data 7 days after each vaccination (reactogenicity, AEs and safety laboratory assessments). In Phase 1b, the DSMB will review blinded Day 7 safety data after the first 10 participants in groups G4 and G5 have received the first dose. Only after the DSMB confirms that safety is acceptable and that stopping rules were not met will the enrollment in the respective study groups continue to its completion.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 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 1a/1b, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of the COVID-19 (SARS-CoV-2) Vaccine Candidates VBI-2902a and VBI-2905a in Healthy Adults
Actual Study Start Date : March 15, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phase 1a, 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.

Biological: Placebo
0.9% sodium chloride

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

Experimental: Phase 1b, Group G4
27 participants age 18-54 will receive VBI-2905a at a dose of 5 μg of S protein at Day 1
Biological: VBI-2905a
VBI-2905a is an intramuscular injection of VBI-2905a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.

Placebo Comparator: Phase 1b, Group G5
27 participants age 18-54 will receive placebo at Day 1
Biological: Placebo
0.9% sodium chloride




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

Secondary Outcome Measures :
  1. Rate and severity of unsolicited adverse events [ Time Frame: Through study completion, approximately 1 year ]
  2. Rate and severity of medically-attended adverse events [ Time Frame: Through study completion, approximately 1 year ]
  3. Rate and severity of serious adverse events [ Time Frame: Through study completion, approximately 1 year ]
  4. Rate and severity of laboratory abnormalities (hematology, biochemistry, urinalysis) [ Time Frame: Through study completion, approximately 1 year ]
  5. Geometric Mean Titer (GMT) and the geometric mean fold increase in serum antibody titer post-vaccination over baseline [ Time Frame: Study Days 56 and 224 (Phase 1a) and 56 and 168 (Phase 1b) ]
  6. GMT and the geometric mean fold increase in serum antibody titer post-vaccination over baseline [ Time Frame: Study Days 7, 28, 35, 56, 112, 224 and 336 (Phase 1a); Days 7, 14, 28, 56, 84, 168 and 336 (Phase 1b) ]


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 54 Years   (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 -54 years of age.
  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 orhysterectomy).
  3. Phase 1b: previously received a full course (2 doses) of an authorized S protein mRNA COVID-19 vaccine (e.g. COVID-19 vaccines produced by Pfizer/BioNTech or Moderna) at least 4 months prior to enrollment.
  4. 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. History of clinical or laboratory diagnosis of COVID-19 or SARS-CoV-2 infection.
  2. Phase 1b: Previous receipt of an experimental or authorized SARS-CoV-2 (COVID-19) vaccines other than an S-protein mRNA vaccine.
  3. Phase 1a: Previous receipt of an experimental or authorized SARS-CoV-2 (COVID-19) vaccine.
  4. Positive PCR or rapid antigen test for SARS-CoV-2 at screening.
  5. 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., SBP >140 mmHg or DBP >90 mmHg)
    4. Chronic kidney disease (e.g., GFR <60 mL/min/1.73 m2)
    5. Chronic liver disease
    6. Obesity (e.g., BMI >30 kg/m2)
  6. Any history of cancer requiring chemotherapy or radiation within 5years.
  7. 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.
  8. Lack of participant's capacity (mental, social, behavioral), in the investigator's judgement, to provide informed consent for participation in the study.
  9. 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).
  10. History of allergic reactions or anaphylactic reaction to any vaccine component.
  11. Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
  12. Pregnant or breastfeeding or plans to conceive from 2 weeks before the study until the end of study.
  13. 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.
  14. 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.
  15. Has received blood products or immunoglobulin within 90 days of enrollment or is likely to require blood products during the study period.
  16. 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.
  17. Immunization with attenuated vaccines (e.g., measles, mumps, and rubella vaccine) within 4 weeks prior to enrollment.
  18. Immunization with inactivated vaccines (e.g., influenza) within 2 weeks prior to enrolment.
  19. Participation in another clinical study within 30 days.
  20. Any skin abnormality or tattoo that would limit post-vaccination injection site assessment.
  21. 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
Sponsors and Collaborators
VBI Vaccines Inc.
Investigators
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Principal Investigator: Joanne M Langley, MD Canadian Center for Vaccinology
Principal Investigator: William Cameron, MD Ottawa Hospital
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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: July 21, 2022
Last Verified: July 2022

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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
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases