What side effects are associated with this type of intervention?

Common treatments for COVID-19, including intranasal vaccines like CVXGA, may cause side effects such as nasal irritation, headache, and mild respiratory symptoms. Other treatments, such as dexamethasone, can lead to psychiatric side effects like depression, emotional lability, and insomnia. Antiviral agents like interferon and lopinavir-ritonavir generally do not interact with psychotropic drugs but can have their own side effects, including gastrointestinal issues and liver enzyme abnormalities. It is important to monitor for these side effects and discuss them with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved remdesivir for the treatment of COVID-19 in both hospitalized and nonhospitalized patients, including adults and children aged 28 days and older who weigh at least 3 kg. Remdesivir is an antiviral agent that has shown efficacy in reducing the time to recovery, particularly in patients who are not critically ill. While the context does not provide specific information on FDA-approved intranasal vaccines targeting the SARS-CoV-2 S-protein, the ongoing trial of CVXGA represents an effort to explore such a treatment modality.

What other types of research exist?

Promising novel alternatives to the CVXGA intranasal vaccine for COVID-19 patients include: 1) An intranasal lentiviral booster (LV::S<subBeta-2P</sub) which has shown strong boost effects on immunity and complete pulmonary protection against variants like Delta. 2) VHH-IgA1.1, an inhalable nanobody IgA fusion molecule, which provides effective mucosal immunity against SARS-CoV-2 including emerging variants like Omicron. 3) PiN-21, an inhalable nanobody, which has demonstrated high efficacy in preventing and treating SARS-CoV-2 infection in preclinical models.

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Virus Therapy

Intranasal COVID Vaccine for COVID-19

Phase 2

Waitlist Available

Research Sponsored by CyanVac LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals ≥ 18 years and ≤ 80 years of age at the time of consent

Be older than 18 years old

Must not have

Received oral, intramuscular or intravenous systemic immunosuppressants, or immune-modifying drugs for >14 days in total within 6 months prior to administration of study vaccine

History of severe COVID-19 infection (e.g., need for oxygenation or ventilatory support)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1-8, day 1-29, and day 1-181 post vaccination

Summary

This trial tests a nasal spray vaccine called CVXGA for COVID-19 in healthy adults aged 18-80. The vaccine uses a harmless virus to help the body learn to fight COVID-19. Participants will be monitored for several months after receiving one dose.

Who is the study for?

Healthy adults aged 18-80 can join this trial. Women who can have children must use contraception or practice abstinence, and men should use condoms. Participants need to be in stable health, not planning major hospital stays, without severe allergies to vaccines, no recent COVID infection or vaccination, and not on certain medications.

What is being tested?

The trial is testing CVXGA, a new intranasal COVID vaccine. It will involve up to 400 participants receiving a single dose of the vaccine through the nose to see how well it triggers an immune response and its safety profile.

What are the potential side effects?

While specific side effects are not listed here, common side effects for nasal vaccines may include nasal congestion or runniness, sore throat, headache, fatigue and possibly sneezing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken immune-suppressing drugs for more than 2 weeks in the last 6 months.

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I had a severe case of COVID-19 that required oxygen or ventilator support.

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I am not in another study and haven't received any experimental treatments in the last 28 days.

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I have had heart inflammation, Kawasaki disease, or multisystem inflammatory syndrome.

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I have or had a condition that weakens my immune system.

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I have had severe wheezing or breathing issues that required hospitalization.

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I do not have advanced liver or kidney diseases.

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I have not been sick or had a fever in the last 72 hours.

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I have advanced HIV, active Hepatitis B, or tested positive for Hepatitis C.

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I have had chemotherapy, immunotherapy, or radiation within the last 6 months.

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I have previously received a PIV5-based vaccine.

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I have a bleeding disorder or bleed easily with injections or blood draws.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1-8, day 1-29, and day 1-181 post vaccination

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1-8, day 1-29, and day 1-181 post vaccination

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1-8, day 1-29, and day 1-181 post vaccination for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Immunogenicity

Safety outcome measures (SAEs, AEs, and local and systemic reactogenicity)

Secondary study objectives

Secondary Immunogenicity

Secondary Safety

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CVXGAExperimental Treatment1 Intervention

CVXGA single intranasal dose 10e7 PFU

Group II: PlaceboPlacebo Group1 Intervention

0.9% sterile saline

0 / 13Eligibility criteria met

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 CVXGA intranasal vaccine targets the SARS-CoV-2 S-protein to induce an immune response, helping the body recognize and combat the virus. Other common treatments include antivirals that inhibit viral replication, immunomodulators that reduce inflammation and cytokine storms, and monoclonal antibodies that neutralize the virus. These mechanisms are vital for COVID-19 patients as they help reduce viral load, control severe immune reactions, and improve recovery outcomes.

Prevalence and outcome of COVID-19 among Iranian celiac patients.TLR4 as a therapeutic target for respiratory and neurological complications of SARS-CoV-2.The race to treat COVID-19: Potential therapeutic agents for the prevention and treatment of SARS-CoV-2.