What side effects are associated with this type of intervention?

Common side effects of SARS-CoV-2 vaccines, such as those similar to VXCO-100, include local reactions at the injection site (pain, redness, swelling), systemic reactions (fever, fatigue, headache, muscle pain), and rare allergic reactions including anaphylaxis. Other treatments for COVID-19, such as antiviral drugs and monoclonal antibodies, may cause gastrointestinal symptoms, infusion-related reactions, and potential liver enzyme elevations. It is important to monitor for these side effects and consult healthcare providers for management.

What prior FDA approvals exist?

The FDA has granted Emergency Use Authorization (EUA) and full approval to several vaccines for the treatment of SARS-CoV-2, focusing on immunogenicity and safety. These include mRNA vaccines such as Pfizer-BioNTech's BNT162b2 (Comirnaty) and Moderna's mRNA-1273, as well as viral vector vaccines like Johnson & Johnson's Ad26.COV2.S. These vaccines have been shown to be effective in generating an immune response and have undergone rigorous safety evaluations. Additionally, treatments like monoclonal antibodies (e.g., Regeneron's REGEN-COV) have been authorized for emergency use to provide passive immunity against the virus.

What other types of research exist?

Promising alternatives to VXCO-100 for treating SARS-CoV-2 patients include: 1) Tixagevimab-cilgavimab, a monoclonal antibody therapy authorized for pre-exposure prophylaxis in immunocompromised individuals. 2) Bivalent mRNA vaccines targeting both the original SARS-CoV-2 strain and Omicron variants, recommended as booster doses. 3) Molnupiravir and nirmatrelvir plus ritonavir, antiviral drugs shown to be effective against COVID-19 in outpatient settings. 4) COH04S1, a synthetic multiantigen modified vaccinia virus Ankara-based vaccine, which has shown safety and immunogenicity in phase 1 trials.

← Back to Search

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

No Placebo-Only Group

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

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

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Do I qualify?Apply below to find out

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.