What side effects are associated with this type of intervention?

Common treatments for COVID-19 include antiviral medications, monoclonal antibodies, and vaccines. Antiviral medications like remdesivir can cause side effects such as nausea, elevated liver enzymes, and allergic reactions. Monoclonal antibodies, such as those previously used like bamlanivimab-etesevimab, may lead to infusion-related reactions, including fever, chills, and rash. Vaccines, including those using virus-like particles (eVLPs) like VBI-2901a, generally have side effects such as injection site pain, fatigue, headache, muscle pain, chills, fever, and nausea. Severe allergic reactions are rare but possible.

What prior FDA approvals exist?

The FDA has granted Emergency Use Authorizations (EUAs) for several COVID-19 vaccines that target the spike protein of SARS-CoV-2 to induce an immune response. These include the Pfizer-BioNTech and Moderna mRNA vaccines, which encode the spike protein to stimulate immunity. Additionally, the Johnson & Johnson vaccine uses a viral vector to deliver the spike protein gene. While specific FDA approvals for treatments using enveloped virus-like particles (eVLPs) like VBI-2901a are not mentioned, these vaccines similarly aim to generate neutralizing antibodies and cell-mediated immune responses against the spike protein of SARS-CoV-2.

What other types of research exist?

Promising novel alternatives to VBI-2901a for COVID-19 treatment in 2024 include: 1) rVSV-ΔG-SARS-CoV-2-S vaccine, which uses a recombinant vesicular stomatitis virus (VSV) platform to express the spike antigen of SARS-CoV-2 and is currently in phase 2 clinical trials. 2) SARS-CoV-2 Virus-Like Particles (VLPs) that mimic the molecular and morphological properties of native virion particles, offering a potential vaccine candidate. 3) Engineered SARS-CoV-2 receptor binding domain (RBD) presented on designed VLPs, which has shown improved manufacturability and immunogenicity in preclinical studies.

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Virus Therapy

Trivalent Coronavirus Vaccine VBI-2901a for COVID-19

Phase 1

Waitlist Available

Led By William Cameron, MD

Research Sponsored by VBI Vaccines Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study days 1, 7, 28, 56, 63, 84, 168 and 336

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new vaccine, VBI-2901a, aimed at protecting against three coronaviruses, including COVID-19. It targets adults aged 18 to 64 who have previously been vaccinated. The vaccine works by using virus-like particles to boost the immune system's response.

Who is the study for?

Adults aged 18-64 who've had at least two COVID-19 vaccine shots can join this trial. They should be healthy or have stable, controlled diseases. Women must not be pregnant/breastfeeding and use birth control; men agree to contraception rules post-vaccination. Exclusions include recent moderate/severe COVID-19 illness, certain infections like HIV/HBV/HCV, recent other vaccines or blood products, immune system issues, and cancer treatments within 5 years.

What is being tested?

The study tests VBI-2901a's safety and its ability to boost immunity against three coronaviruses: SARS-CoV-2 (including variants), SARS-CoV-1, and MERS-CoV. Participants will receive either two doses of the vaccine at different strengths or one dose to compare responses in those previously vaccinated for COVID-19.

What are the potential side effects?

Potential side effects are not detailed but may include typical reactions seen with vaccines such as soreness at injection site, fever, fatigue, headache or allergic reactions. The study aims to assess these tolerability aspects of VBI-2901a.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study days 1, 7, 28, 56, 63, 84, 168 and 336

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study days 1, 7, 28, 56, 63, 84, 168 and 336

This trial's timeline: 3 weeks for screening, Varies for treatment, and study days 1, 7, 28, 56, 63, 84, 168 and 336 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Muscle strain

Secondary study objectives

Immunoglobulin G

Geometric mean fold rise (GMFR) in serum neutralizing antibody titer against SARS-CoV-2 ancestral (Wuhan) strain and variants of concern (Beta, Delta and Omicron), SARS-CoV-1 and MERS-CoV

Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibodies

+4 more

Other study objectives

Zoonoses

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group G3Experimental Treatment1 Intervention

33 participants aged 18-64 years to receive one dose of VBI-2901a at 10 µg per dose at Day 1.

Group II: Group G2Experimental Treatment1 Intervention

33 participants aged 18-64 years to receive two doses of VBI-2901a at 10 µg per dose at Day 1 and Day 56.

Group III: Group G1Experimental Treatment1 Intervention

33 participants aged 18-64 years to receive two doses of VBI-2901a at 5 µg per dose at Day 1 and Day 56.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for COVID-19 include antiviral therapies, immunotherapies, and vaccines. Antiviral therapies work by inhibiting the replication of the virus, thereby reducing the viral load in the body. Immunotherapies, such as convalescent plasma and monoclonal antibodies, enhance the body's immune response to fight the virus. Vaccines, like the VBI-2901a candidate, use enveloped virus-like particles (eVLPs) to express spike proteins, which stimulate the immune system to produce neutralizing antibodies and cell-mediated responses. This is crucial for COVID-19 patients as it helps in preventing severe disease, reducing transmission, and potentially providing long-term immunity against the virus and its variants.

Biomaterials-Based Opportunities to Engineer the Pulmonary Host Immune Response in COVID-19.TLR4 as a therapeutic target for respiratory and neurological complications of SARS-CoV-2.A brief review of the latest pharmacological treatments of COVID-19.