VXCO-100 Vaccine for COVID-19

No longer recruiting at 2 trial locations

Overseen By Vaccine Company, Inc. Trial Inquiries

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Vaccine Company, Inc.

Must not be taking: Immunosuppressants, Cytotoxic medications

Disqualifiers: COVID-19, COPD, Diabetes, Heart conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new COVID-19 vaccine, VXCO-100, to evaluate its safety and effectiveness in building immunity. Researchers will administer varying doses to different groups of healthy adults to determine the optimal amount for protection. Individuals who have received at least three COVID-19 mRNA vaccine shots and show no symptoms or recent infection may qualify for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressants or certain other medications, you may need to stop them before joining. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that VXCO-100 is likely to be safe for humans?

Research shows that VXCO-100 is a new COVID-19 vaccine undergoing testing for safety and effectiveness in healthy adults. As this is an early-stage trial, limited human data exists. This phase primarily assesses how well participants tolerate the vaccine. Early trials focus on safety, so researchers closely monitor any serious side effects.

Animal studies have shown that similar vaccines can generate a strong immune response without major issues. However, human trials are crucial to confirm these findings. Participants in the VXCO-100 trial receive varying doses to observe their reactions and ensure safety. This careful testing helps researchers identify the safest and most effective dose.

For those considering joining a clinical trial like this, all potential side effects and risks are explained to participants beforehand. This ensures everyone is informed and comfortable with their decision. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about VXCO-100 for COVID-19 because it offers a promising new approach to vaccination. Unlike traditional vaccines that often use inactivated viruses or viral proteins, VXCO-100 might utilize novel components or delivery systems to stimulate the immune system more effectively. This vaccine is being tested at various dose levels for different age groups, which could optimize its effectiveness and safety across a broad population. If successful, VXCO-100 could provide a more robust immune response and potentially offer longer-lasting protection compared to existing COVID-19 vaccines.

What evidence suggests that the VXCO-100 vaccine could be an effective treatment for COVID-19?

Research has shown that a similar vaccine, NVX-CoV2373, was 89.7% effective in preventing COVID-19 in a large UK study. This high effectiveness suggests that VXCO-100, also a protein-based vaccine, might perform well. Other studies on COVID-19 vaccines have demonstrated effectiveness rates between 60% and 94.1% after the first dose. These findings encourage confidence in VXCO-100's potential to protect against COVID-19. While VXCO-100 remains under testing, it is designed using methods successful in other vaccines. Participants in this trial will receive VXCO-100 at different dose levels based on their age group, as part of the various treatment arms. ^{1 2 6 7 8}

Who Is on the Research Team?

Nadine Rouphael, MD

Principal Investigator

Emory University

Justin Ortiz, MD, MS

Principal Investigator

University of Maryland

Angela Branche, MD

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

Healthy adults over 18 who've had at least 3 COVID-19 mRNA vaccine shots, with the last one being over 6 months ago. They must have normal organ function tests, not be pregnant or planning pregnancy soon, and agree to follow study procedures for up to 24 months. People with recent SARS-CoV-2 infection, other vaccinations close to trial start, immune system issues, or severe chronic diseases can't join.

Inclusion Criteria

Judged by the investigator to be healthy based on participant-reported medical history, physical examination, vital signs, and laboratory assessment

Hemoglobin within institutional normal range or accompanied by the PI or designee approval

For participants of childbearing potential: Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test (urine or serum) on the day of enrollment

Exclusion Criteria

I have a known blood clotting disorder.

I have had myocarditis or pericarditis in the past.

Evidence of infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of VXCO-100 on Day 1, with an optional interim boost at month 3

3 months

1 visit (in-person) for initial dose, optional visit for boost

Follow-up

Participants are monitored for safety and immunogenicity after vaccination

3 months

What Are the Treatments Tested in This Trial?

Interventions

• VXCO-100

Trial Overview

The VXCO-100 vaccine is being tested in this trial. It's given in different doses to see how safe it is and how well it works (immunogenicity) in people who are already vaccinated against COVID-19.

How Is the Trial Designed?

Group I: VXCO-100 Group 6 Experimental Treatment 1 Intervention

Participants 56+ years of age will receive VXCO-100 at Dose Level 3 via intramuscular (IM) injection

Group II: VXCO-100 Group 5 Experimental Treatment 1 Intervention

Participants 56+ years of age will receive VXCO-100 at Dose Level 2 via intramuscular (IM) injection

Group III: VXCO-100 Group 4 Experimental Treatment 1 Intervention

Participants 56+ years of age will receive VXCO-100 at Dose Level 1 via intramuscular (IM) injection

Group IV: VXCO-100 Group 3 Experimental Treatment 1 Intervention

Participants 18-55 years of age will receive VXCO-100 at Dose Level 3 via intramuscular (IM) injection

Group V: VXCO-100 Group 2 Experimental Treatment 1 Intervention

Participants 18-55 years of age will receive VXCO-100 at Dose Level 2 via intramuscular (IM) injection

Group VI: VXCO-100 Group 1 Experimental Treatment 1 Intervention

Participants 18-55 years of age will receive VXCO-100 at Dose Level 1 via intramuscular (IM) injection

Who Is Running the Clinical Trial?

Vaccine Company, Inc.

Lead Sponsor

Trials

2

Recruited

250+

Published Research Related to This Trial

In a study of 395 healthcare workers who received the Oxford/AstraZeneca COVID-19 vaccine, 270 participants (68.4%) reported at least one adverse event, with common symptoms including muscle ache, fatigue, headache, and fever.

No serious adverse events such as hospitalization, disability, or death were reported, indicating that while mild to moderate side effects are common, the vaccine is generally safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of Oxford/AstraZeneca's COVID-19 vaccine among health care workers of Ayder Comprehensive Specialized Hospital, Tigray, Ethiopia. Tequare, MH., Abraha, HE., Adhana, MT., et al.[2022]

Most adverse events reported from COVID-19 vaccines were mild or moderate, indicating a generally favorable safety profile during clinical trials.

However, some viral vector-based vaccines were associated with thrombotic events, highlighting the need for ongoing studies and post-marketing surveillance to fully understand potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[COVID-19 vaccine safety]. Chaparro Mérida, NA., Moreno Samper, D., Lacato, AOF.[2022]

A scoping review of 11 studies found that adverse events related to COVID-19 vaccinations are generally mild to moderate, with no significant impact on daily activities and no unique patterns in vaccine-related deaths, indicating a strong safety profile for the vaccines.

The review highlights the importance of accurate public communication regarding vaccine side effects and emphasizes the need for strategies to address vaccine hesitancy, suggesting that future research should focus on diverse populations and medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Reactions of COVID-19 Vaccines: A Scoping Review of Observational Studies. Dhamanti, I., Suwantika, AA., Adlia, A., et al.[2023]

A total of 604,157 adverse events (AEs) were reported for COVID-19 vaccines, with the Pfizer-BioNTech and Moderna vaccines accounting for the majority of reports, indicating a need for ongoing safety monitoring.

While most reported AEs were mild, serious outcomes like hospitalization and life-threatening events were noted, particularly among older adults with pre-existing conditions, highlighting the importance of careful surveillance of vaccine safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and Comparison of Adverse Events of Coronavirus Disease 2019 Vaccines Reported to the United States Vaccine Adverse Event Reporting System Between 14 December 2020 and 8 October 2021. Zou, C., Xue, X., Qian, J.[2022]

The NVX-CoV2373 vaccine demonstrated an 82.7% efficacy against COVID-19 in a large study of 15,185 participants, with 100% efficacy against severe disease, indicating strong protection for vaccinated individuals.

The vaccine induced robust immune responses, including high levels of anti-spike IgG and T-cell activation, while showing a similar incidence of adverse events compared to the placebo group, suggesting it is safe and effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of the NVX-CoV2373 Coronavirus Disease 2019 Vaccine at Completion of the Placebo-Controlled Phase of a Randomized Controlled Trial. Heath, PT., Galiza, EP., Baxter, DN., et al.[2023]

A study involving 451 adults showed that inhaled adenovirus-vectored COVID-19 vaccines, including a bivalent and a variant-specific option, were safe and well tolerated, with mostly mild to moderate side effects and no serious adverse events reported.

The bivalent vaccine induced a significantly higher level of neutralizing antibodies against the Omicron variant compared to the standard vaccine, suggesting it may provide enhanced protection against SARS-CoV-2 variants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of heterologous boosting with orally administered aerosolized bivalent adenovirus type-5 vectored COVID-19 vaccine and B.1.1.529 variant adenovirus type-5 vectored COVID-19 vaccine in adults 18 years and older: a randomized, double blinded, parallel controlled trial. Xu, JW., Wang, BS., Gao, P., et al.[2023]

The NVX-CoV2373 COVID-19 vaccine induces a strong CD4+ T-cell response, particularly after two doses, with a significant majority (93.5%) of recipients showing interferon-γ responses, indicating robust immune activation.

This vaccine elicits a Th1-biased immune response that is cross-reactive to various SARS-CoV-2 variants, including Omicron, suggesting it may provide broad protection against different strains of the virus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strong CD4+ T-Cell Responses to Ancestral and Variant Spike Proteins Are Established by NVX-CoV2373 Severe Acute Respiratory Syndrome Coronavirus 2 Primary Vaccination. Fries, L., Formica, N., Mallory, RM., et al.[2023]

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VXCO-100 Vaccine for COVID-19 · Info for Participants

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