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Virus Therapy

VXCO-100 Vaccine for COVID-19

Phase 1
Waitlist Available
Led By Kathleen Neuzil, MD, MPH
Research Sponsored by Vaccine Company, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects of VXCO-100 aren't listed here, common vaccine-related side effects include pain at the injection site, fatigue, headache, muscle pain, chills, fever and nausea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

6Treatment groups
Experimental Treatment
Group I: VXCO-100 Group 6Experimental Treatment1 Intervention
Participants 56+ years of age will receive VXCO-100 at Dose Level 3 via intramuscular (IM) injection
Group II: VXCO-100 Group 5Experimental Treatment1 Intervention
Participants 56+ years of age will receive VXCO-100 at Dose Level 2 via intramuscular (IM) injection
Group III: VXCO-100 Group 4Experimental Treatment1 Intervention
Participants 56+ years of age will receive VXCO-100 at Dose Level 1 via intramuscular (IM) injection
Group IV: VXCO-100 Group 3Experimental Treatment1 Intervention
Participants 18-55 years of age will receive VXCO-100 at Dose Level 3 via intramuscular (IM) injection
Group V: VXCO-100 Group 2Experimental Treatment1 Intervention
Participants 18-55 years of age will receive VXCO-100 at Dose Level 2 via intramuscular (IM) injection
Group VI: VXCO-100 Group 1Experimental Treatment1 Intervention
Participants 18-55 years of age will receive VXCO-100 at Dose Level 1 via intramuscular (IM) injection

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 Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV) include antiviral drugs, immunomodulators, and vaccines. Antiviral drugs, such as remdesivir, inhibit viral replication by targeting viral RNA polymerase. Immunomodulators like tocilizumab reduce inflammation by inhibiting the IL-6 pathway, which can prevent severe immune responses. Vaccines, such as those being studied in the VXCO-100 trial, work by stimulating the immune system to produce antibodies and memory cells that recognize and fight the virus upon exposure. These treatments are crucial for SARS-CoV patients as they can reduce viral load, mitigate severe inflammatory responses, and provide long-term immunity, thereby decreasing morbidity and mortality.
Drug Discovery Strategies for SARS-CoV-2.Hydroxychloroquine against COVID-19: A critical appraisal of the existing evidence.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Vaccine Company, Inc.Lead Sponsor
1 Previous Clinical Trials
130 Total Patients Enrolled
Kathleen Neuzil, MD, MPHPrincipal InvestigatorUniversity of Maryland
Nadine Rouphael, MDPrincipal InvestigatorEmory University
16 Previous Clinical Trials
782 Total Patients Enrolled

Media Library

VXCO-100 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05870839 — Phase 1
Severe Acute Respiratory Syndrome Coronavirus Clinical Trial 2023: VXCO-100 Highlights & Side Effects. Trial Name: NCT05870839 — Phase 1
VXCO-100 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05870839 — Phase 1
Severe Acute Respiratory Syndrome Coronavirus Research Study Groups: VXCO-100 Group 2, VXCO-100 Group 4, VXCO-100 Group 5, VXCO-100 Group 3, VXCO-100 Group 6, VXCO-100 Group 1
~52 spots leftby Oct 2025