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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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.
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
Eligibility Criteria:
This trial includes the following eligibility 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.I have an immune system condition like immune deficiency or leukemia.I am 18 years old or older.I do not have severe brain conditions or serious mental health issues.I have not had COVID-19 treatment or monoclonal antibody infusion in the last 6 months.I have received a COVID-19 vaccine in the last 6 months.I have had symptoms like fever, cough, or difficulty breathing in the last 14 days.I have a significant health or mental health condition.I have had COVID-19 or tested positive for it in the last 6 months.I haven't had a live vaccine in the last 30 days or any vaccine in the last 14 days.I have been in close contact with a COVID-19 case recently.I am willing to follow the study's rules for 12 or 24 months.I've had 3 or more COVID-19 mRNA vaccine shots, with the last one over 6 months ago.I haven't taken strong immune system or cancer drugs in the last month.I have not received any blood products in the last 3 months.I am not breastfeeding or planning to become pregnant during the trial.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: VXCO-100 Group 2
- Group 2: VXCO-100 Group 4
- Group 3: VXCO-100 Group 5
- Group 4: VXCO-100 Group 3
- Group 5: VXCO-100 Group 6
- Group 6: VXCO-100 Group 1
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