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

NCT04773665 | Completed Phase 1 Results DMC

• 1 other identifier: VBI-2902a-CT01
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 4

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.

Conditions

Covid19

Keywords

enveloped virus-like particle (eVLP); SARS-CoV-2 spike; neutralizing antibody; cell-mediated immune responses

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Through 28 days after each study vaccination

Secondary Outcomes (4)

• Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a)

  Study Days 1, 7, 28, 35 and 56

• Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a)

  Study Days 1, 7, 28, 35, 56 and 112

• Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b)

  Study Days 1, 7, 14, 28, 56, 84 and 168

• Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1b)

  Study Days 1, 7,14, 28, 56, 84,168 and 336

Study Arms (5)

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

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

Biological: VBI-2902a

Phase 1a, Group G3

PLACEBO COMPARATOR

20 participants age 18-54 will receive placebo at Days 1 and 28

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

Biological: VBI-2905a

Phase 1b, Group G5

PLACEBO COMPARATOR

27 participants age 18-54 will receive placebo at Day 1

Biological: Placebo

Interventions

VBI-2902a BIOLOGICAL

VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.

Phase 1a, Group G1; Phase 1a, Group G2

Placebo BIOLOGICAL

0.9% sodium chloride

Phase 1a, Group G1; Phase 1a, Group G3; Phase 1b, Group G5

VBI-2905a BIOLOGICAL

VBI-2905a is an intramuscular injection of VBI-2905a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.

Phase 1b, Group G4

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• VBI Vaccines Inc.: lead

Study Sites (4)

Canadian Center for Vaccinology

Halifax, Nova Scotia, Canada

Location

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

LMC Manna - Bayview CPU

Toronto, Ontario, M4G 3E8, Canada

Location

Manna Toronto

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Francisco Diaz-Mitoma, MD, PhD
• Organization: VBI Vaccines Inc

fdiazmitoma@vbivaccines.com

613-749-4200

Study Officials

• Joanne M Langley, MD

  Canadian Center for Vaccinology

  PRINCIPAL INVESTIGATOR

• William Cameron, MD

  Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: February 26, 2021
• Study Start: March 15, 2021
• Primary Completion: November 14, 2022
• Study Completion: November 14, 2022
• Last Updated: May 17, 2024
• Results First Posted: May 17, 2024

Record last verified: 2024-05

Locations

CA (4)