VXCO-100 Vaccine for COVID-19

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

121 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new vaccine called VXCO-100 in healthy adults to see if it is safe and can trigger an immune response. Participants will receive one dose, with some getting an optional booster after a few months. The study will carefully monitor safety before increasing doses or including older adults.

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.

What data supports the effectiveness of the VXCO-100 treatment for COVID-19?

The NVX-CoV2373 vaccine, which is a similar protein-based vaccine, showed 89.7% effectiveness against COVID-19 in a large trial in the UK. This suggests that protein-based vaccines like VXCO-100 could also be effective. ^{1 2 3 4 5}

Is the VXCO-100 COVID-19 vaccine safe for humans?

The safety of COVID-19 vaccines, including those similar to VXCO-100, has been studied extensively. Most side effects are mild or moderate, like sore arms or tiredness, but rare serious reactions like allergic responses have been reported. Overall, these vaccines are considered safe for humans. ^{6 7 8 9 10}

How does the VXCO-100 vaccine for COVID-19 differ from other treatments?

The VXCO-100 vaccine is unique because it is an egg-based inactivated vaccine using the Newcastle disease virus to express the spike protein of the coronavirus, which may make it more affordable and accessible for low- and middle-income countries. ^{1 11 12 13 14}

Research Team

Justin Ortiz, MD, MS

Principal Investigator

University of Maryland

Nadine Rouphael, MD

Principal Investigator

Emory University

Angela Branche, MD

Principal Investigator

University of Rochester

Eligibility Criteria

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

I am 18 years old or older.

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

Exclusion Criteria

I have a known blood clotting disorder.

I have had myocarditis or pericarditis in the past.

I do not have severe liver or kidney diseases, uncontrolled high blood pressure, or other active cancers.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

References

1. United States 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness of BNT162b2 and mRNA-1273 covid-19 vaccines against symptomatic SARS-CoV-2 infection and severe covid-19 outcomes in Ontario, Canada: test negative design study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Vaccination provides protection from respiratory deterioration and death among hospitalized COVID-19 patients: Differences between vector and mRNA vaccines. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Real-world effectiveness of the mRNA-1273 vaccine against COVID-19: Interim results from a prospective observational cohort study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Immune Correlates Analysis of the mRNA-1273 COVID-19 Vaccine Efficacy Trial. [2023]

6. Peru pubmed.ncbi.nlm.nih.gov

[COVID-19 vaccine safety]. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Safety profile of COVID-19 vaccines, preventive strategies, and patient management. [2022]

8. England 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. [2022]

9. Switzerland 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. [2022]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Adverse Reactions of COVID-19 Vaccines: A Scoping Review of Observational Studies. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of an egg-based inactivated Newcastle disease virus vaccine expressing SARS-CoV-2 spike: Interim results of a randomized, placebo-controlled, phase 1/2 trial in Vietnam. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

COVID-eVax, an electroporated DNA vaccine candidate encoding the SARS-CoV-2 RBD, elicits protective responses in animal models. [2022]

13. United States 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. [2023]

14. United States 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. [2023]