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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 for 7 days after each product administration
Awards & highlights

Study Summary

This trial tests a new vaccine to see if it's safe and effective in healthy 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.Check my eligibility
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.See study design
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 ~at baseline and 7 days after each product administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and 7 days after each product administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number and percentage of participants with solicited local adverse events
Number and percentage of participants with solicited systemic adverse events
Number and percentage of participants with unsolicited and safety laboratory-based adverse events
+1 more
Secondary outcome measures
Numbers and percentages of participants with positive Th1 or Th2 cytokine responses for CD4 and CD8 as measured by multi-parameter intracellular cytokine staining
Response rate measured by GMT of Nab against selected variants of concern
Response rate measured by geometric mean titer of the serum neutralizing antibody (Nab) against the ancestral (Wuhan) strain

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

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned VXCO-100 Group 1 for usage?

"Since VXCO-100 Group 1 is in its first stage of clinical trials, the safety score assigned by our team at Power was a mere 1 due to lack of data supporting both efficacy and safety."

Answered by AI

Are there still opportunities to enroll in this experimental research?

"Per information found on clinicaltrials.gov, this scientific trial is presently recruiting participants. The initial posting date was May 11th 2023 and the most recent update occurred on May 19th 2023."

Answered by AI

What is the current cap on participants for this trial?

"Vaccine Company, Inc. is seeking 120 qualified participants for their medical trial at two different sites: the University of Maryland, Baltimore's Center for Vaccine Development and Global Health in Baltimore, MD; as well as Rochester Medical Center - Vaccine Research Unit located in New york."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
The Hope Clinic of Emory University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study of VXCO-100, a SARS-CoV Candidate Vaccine in Healthy Adults in the United States
2023. "Study of VXCO-100, a SARS-CoV Candidate Vaccine in Healthy Adults in the United States". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05870839.
~0 spots leftby May 2024
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