Covid19Phase 1NCT04773665
Safety, Tolerability, and Immunogenicity of the COVID-19 Vaccine Candidates VBI-2902a and VBI-2905a
A Phase 1 study testing VBI-2902a and VBI-2905a in people with Covid19, run by VBI Vaccines Inc. at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- VBI-2902a and VBI-2905a
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 4 sitesCanada
- Study dates
- 15 Mar 2021to 14 Nov 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be eligible for the study, each participant must satisfy all of the following criteria:
- Healthy female and male participants 18 -54 years of age.
- If female:
- 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
- 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).
- 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.
- Sign an informed consent document indicating understanding of the purpose of and procedures required for the study and willingness to participate in the study.
Who cannot join
- Participants with any of the following criteria will be excluded:
- History of clinical or laboratory diagnosis of COVID-19 or SARS-CoV-2 infection.
- Phase 1b: Previous receipt of an experimental or authorized SARS-CoV-2 (COVID-19) vaccines other than an S-protein mRNA vaccine.
- Phase 1a: Previous receipt of an experimental or authorized SARS-CoV-2 (COVID-19) vaccine.
- Positive PCR or rapid antigen test for SARS-CoV-2 at screening.
- Individuals with chronic medical conditions, including any of the following:
Show all 31Show fewer
- Diabetes mellitus Type 1 or Type 2
- Chronic pulmonary disease (e.g., COPD or Asthma)
- Hypertension (e.g., SBP >140 mmHg or DBP >90 mmHg)
- Chronic kidney disease (e.g., GFR <60 mL/min/1.73 m2)
- Chronic liver disease
- Obesity (e.g., BMI >30 kg/m2)
- Any history of cancer requiring chemotherapy or radiation within 5years.
- 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.
- Lack of participant's capacity (mental, social, behavioral), in the investigator's judgement, to provide informed consent for participation in the study.
- Known or suspected impairment of immunological function, including but not limited to autoimmune diseases:
- 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);
- secondary immunodeficiency disorders (e.g., Acquired Immunodeficiency Syndrome caused by Human Immunodeficiency Virus infection (HIV/AIDS), solid organ transplant,splenectomy);
- primary immunodeficiency disorders (e.g., common variable immune deficiency (CVID), Defective phagocytic cell function and neutropenia syndromes, complement deficiency).
- History of allergic reactions or anaphylactic reaction to any vaccine component.
- Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
- Pregnant or breastfeeding or plans to conceive from 2 weeks before the study until the end of study.
- 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.
- 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.
- Has received blood products or immunoglobulin within 90 days of enrollment or is likely to require blood products during the study period.
- 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.
- Immunization with attenuated vaccines (e.g., measles, mumps, and rubella vaccine) within 4 weeks prior to enrollment.
- Immunization with inactivated vaccines (e.g., influenza) within 2 weeks prior to enrolment.
- Participation in another clinical study within 30 days.
- Any skin abnormality or tattoo that would limit post-vaccination injection site assessment.
- Family members of study site personnel.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Canadian Center for Vaccinology
Halifax, Nova Scotia
Ottawa Hospital
Ottawa, Ontario, K1H 8L6
LMC Manna - Bayview CPU
Toronto, Ontario, M4G 3E8
Manna Toronto
Toronto, Ontario
About this study
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
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- VBI-2902a, Placebo, VBI-2905a
- Keywords
- enveloped virus-like particle (eVLP), SARS-CoV-2 spike, neutralizing antibody, cell-mediated immune responses
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VBI-2902aBiological
VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
PlaceboBiological
0.9% sodium chloride
VBI-2905aBiological
VBI-2905a is an intramuscular injection of VBI-2905a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a, Group G1 | Experimental | 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 Receives: Biological: VBI-2902a; Biological: Placebo |
| Phase 1a, Group G2 | Experimental | 20 participants age 18-54 will receive VBI-2902a at a dose of 5 μg of S protein at Days 1 and 28 Receives: Biological: VBI-2902a |
| Phase 1a, Group G3 | Placebo comparator | 20 participants age 18-54 will receive placebo at Days 1 and 28 Receives: Biological: Placebo |
| Phase 1b, Group G4 | Experimental | 27 participants age 18-54 will receive VBI-2905a at a dose of 5 μg of S protein at Day 1 Receives: Biological: VBI-2905a |
| Phase 1b, Group G5 | Placebo comparator | 27 participants age 18-54 will receive placebo at Day 1 Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Local Solicited Adverse Events After Each Study Vaccination
The occurrence of local (near injection site) adverse events actively solicited from the participant during the post-administration follow-up period.
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with this treatment. An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
Measured: Through 7 days after each study vaccination
Rate of Systemic Solicited Adverse Events After Each Study Vaccination
The occurrence of systemic adverse events actively solicited from the participant during the post-administration follow-up period.
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with this treatment. An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
Measured: Through 7 days after each study vaccination
Rate of Unsolicited Adverse Events After Each Study Vaccination
Any adverse event reported in addition to those solicited during the clinical study.
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with this treatment. An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
Measured: Through 28 days after each study vaccination
Secondary outcomes (4)
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a)
Virus-neutralizing antibody titers in serum were determined at baseline and post-vaccination using a pseudovirus neutralization assay (PNA). Titers are expressed as the highest serum dilution neutralizing 50% of viral infectivity (PNA50). Neutralization was tested against pseudoviruses expressing the spike protein of the ancestral (Wuhan) SARS-CoV-2 virus as well as Beta and Delta variants.
Measured: Study Days 1, 7, 28, 35 and 56
Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a)
Binding of serum antibody to SARS-CoV-2 spike protein was determined at baseline and post-vaccination by enzyme-linked immunosorbent assay (ELISA). Antibody levels are expressed as ELISA laboratory units (ELU)/mL. Binding antibody was tested against the spike protein of the ancestral (Wuhan) SARS-CoV-2 virus.
Measured: Study Days 1, 7, 28, 35, 56 and 112
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b)
Virus-neutralizing antibody titers in serum were determined at baseline and post-vaccination using a pseudovirus neutralization assay (PNA). Titers are expressed as the highest serum dilution neutralizing 50% of viral infectivity (PNA50). Neutralization was tested against pseudoviruses expressing the spike protein of the ancestral (Wuhan) SARS-CoV-2 virus as well as Beta and Delta variants.
Measured: Study Days 1, 7, 14, 28, 56, 84 and 168
Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1b)
Binding of serum antibody to SARS-CoV-2 spike protein was determined at baseline and post-vaccination by enzyme-linked immunosorbent assay (ELISA). Antibody levels are expressed as ELISA laboratory units (ELU)/mL. Binding antibody was tested against the spike protein of the ancestral (Wuhan) SARS-CoV-2 virus.
Measured: Study Days 1, 7,14, 28, 56, 84,168 and 336
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start15 Mar 2021
- Primary completion14 Nov 2022
- Study completion14 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- VBI Vaccines Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joanne M Langley, MD, Principal investigator, Canadian Center for VaccinologyWilliam Cameron, MD, Principal investigator, Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773665
- Sponsor's protocol ID
- VBI-2902a-CT01
- Status last verified
- May 2024
- First submitted
- 24 Feb 2021
- Last updated
- 17 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04773665
- Acronym / sponsor ID
- VBI-2902a-CT01
- Conditions
- Covid19
- Keywords
- enveloped virus-like particle (eVLP), SARS-CoV-2 spike, neutralizing antibody, cell-mediated immune responses
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- VBI Vaccines Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 14 Nov 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Posted 17 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Phase 1a, Group G1 | Experimental | Biological: VBI-2902a, Biological: Placebo20 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 |
| Phase 1a, Group G2 | Experimental | Biological: VBI-2902a20 participants age 18-54 will receive VBI-2902a at a dose of 5 μg of S protein at Days 1 and 28 |
| Phase 1a, Group G3 | Placebo comparator | Biological: Placebo20 participants age 18-54 will receive placebo at Days 1 and 28 |
| Phase 1b, Group G4 | Experimental | Biological: VBI-2905a27 participants age 18-54 will receive VBI-2905a at a dose of 5 μg of S protein at Day 1 |
| Phase 1b, Group G5 | Placebo comparator | Biological: Placebo27 participants age 18-54 will receive placebo at Day 1 |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- To be eligible for the study, each participant must satisfy all of the following criteria:
- Healthy female and male participants 18 -54 years of age.
- If female:
- OR
- 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.
Key exclusion criteria (31 listed)
- History of clinical or laboratory diagnosis of COVID-19 or SARS-CoV-2 infection.
- Phase 1b: Previous receipt of an experimental or authorized SARS-CoV-2 (COVID-19) vaccines other than an S-protein mRNA vaccine.
- Phase 1a: Previous receipt of an experimental or authorized SARS-CoV-2 (COVID-19) vaccine.
- Positive PCR or rapid antigen test for SARS-CoV-2 at screening.
- Individuals with chronic medical conditions, including any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VBI-2902aVBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant. | Biological | Phase 1a, Group G1, Phase 1a, Group G2 |
| Placebo0.9% sodium chloride | Biological | Phase 1a, Group G1, Phase 1a, Group G3, Phase 1b, Group G5 |
| VBI-2905aVBI-2905a is an intramuscular injection of VBI-2905a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant. | Biological | Phase 1b, Group G4 |
Primary outcome
Rate of Local Solicited Adverse Events After Each Study Vaccination
Time frame: Through 7 days after each study vaccination
The occurrence of local (near injection site) adverse events actively solicited from the participant during the post-administration follow-up period. An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with this treatment. An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
Rate of Systemic Solicited Adverse Events After Each Study Vaccination
Time frame: Through 7 days after each study vaccination
The occurrence of systemic adverse events actively solicited from the participant during the post-administration follow-up period. An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with this treatment. An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
Rate of Unsolicited Adverse Events After Each Study Vaccination
Time frame: Through 28 days after each study vaccination
Any adverse event reported in addition to those solicited during the clinical study. An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with this treatment. An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
4 secondary outcomes
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a)
Time frame: Study Days 1, 7, 28, 35 and 56
Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a)
Time frame: Study Days 1, 7, 28, 35, 56 and 112
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b)
Time frame: Study Days 1, 7, 14, 28, 56, 84 and 168
Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1b)
Time frame: Study Days 1, 7,14, 28, 56, 84,168 and 336
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne M Langley, MD principal investigator
Canadian Center for Vaccinology
William Cameron, MD principal investigator
Ottawa Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VBI-2902a and VBI-2905a in people with Covid19, run by VBI Vaccines Inc. at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Local Solicited Adverse Events After Each Study Vaccination (time frame: Through 7 days after each study vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.