Intranasal COVID Vaccine for COVID-19

Recruiting at 10 trial locations

Overseen By Michael Zimmerman, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: CyanVac LLC

Must not be taking: Intranasal medications

Disqualifiers: Pregnancy, Severe Covid history, Immunocompromised, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

227 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use any intranasal medications from 7 days before until 28 days after the trial vaccination.

What data supports the effectiveness of the intranasal COVID treatment CVXGA1?

Research shows that the intranasal COVID treatment CVXGA1 is effective in animal models, inducing antibodies that protect against different variants of the virus. It also maintains antibody levels over time and enhances immune response when used as a booster after mRNA vaccines. ^{1 2 3 4 5}

Is the intranasal COVID-19 vaccine safe for humans?

Research on a similar intranasal COVID-19 vaccine in pigs showed no adverse reactions, suggesting it is safe in that model. Additionally, a study on a different inhaled COVID-19 vaccine in humans found it to be safe and well-tolerated, with only mild to moderate side effects like dry mouth and headache. ^{6 7 8 9 10}

How is the CVXGA1 COVID-19 vaccine different from other COVID-19 vaccines?

The CVXGA1 vaccine is unique because it is administered intranasally (through the nose), which helps induce both systemic and mucosal immunity, potentially blocking the virus at its entry point. Unlike traditional vaccines, it uses a parainfluenza virus 5 (PIV5) vector and can be effective as a single dose or as a booster, maintaining strong antibody responses over time. ^{1 2 3 4 11}

Research Team

Paul Spearman, MD

Principal Investigator

CCHMC

Eligibility Criteria

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.

Inclusion Criteria

I agree not to donate eggs for 90 days after getting vaccinated.

Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests and other study procedures

I am using or willing to use birth control or practice abstinence.

Exclusion Criteria

Study personnel or an immediate family member or household member of study personnel

You have a condition that affects your memory or thinking, which might make it hard for you to understand the clinical trial or follow the rules.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intranasal dose of CVXGA or placebo

1 day

1 visit (in-person)

Initial Follow-up

Participants are monitored for immunogenicity and safety, including local and systemic reactions

4 weeks

2 visits (in-person), 1 follow-up phone call

Extended Follow-up

Participants are monitored for safety, including serious adverse events and immune response

6 months

Treatment Details

Interventions

• CVXGA1

Trial Overview 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.

Participant Groups

Group I: CVXGA Experimental Treatment 1 Intervention

CVXGA single intranasal dose 10e7 PFU

Group II: Placebo Placebo Group 1 Intervention

0.9% sterile saline

Who Is Running the Clinical Trial?

CyanVac LLC

Lead Sponsor

Trials

3

Recruited

10,300+

Findings from Research

The intranasal CVXGA1 vaccine, which uses a parainfluenza virus vector, has shown strong efficacy in animal models by inducing neutralizing antibodies against multiple SARS-CoV-2 variants and protecting against both homologous and heterologous virus challenges.

When used as a booster after mRNA vaccines, CVXGA1 and other PIV5-vectored vaccines produced higher levels of cross-reactive neutralizing antibodies compared to three doses of mRNA vaccines, suggesting they could enhance protection against emerging variants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Parainfluenza Virus 5 (PIV5)-vectored Intranasal COVID-19 Vaccine as a Single Dose Vaccine and as a Booster against SARS-CoV-2 Variants. Beavis, AC., Li, Z., Briggs, K., et al.[2023]

A total of 604,157 adverse events (AEs) were reported for COVID-19 vaccines, with the Pfizer-BioNTech and Moderna vaccines accounting for the majority of reports, indicating a need for ongoing safety monitoring.

While most reported AEs were mild, serious outcomes like hospitalization and life-threatening events were noted, particularly among older adults with pre-existing conditions, highlighting the importance of careful surveillance of vaccine safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and Comparison of Adverse Events of Coronavirus Disease 2019 Vaccines Reported to the United States Vaccine Adverse Event Reporting System Between 14 December 2020 and 8 October 2021. Zou, C., Xue, X., Qian, J.[2022]

The experimental intranasal vaccine AVX/COVID-12-HEXAPRO demonstrated strong safety and immunogenicity in a pig model, showing no adverse reactions and eliciting robust neutralizing antibody responses against SARS-CoV-2 variants.

This vaccine could potentially address global demand for COVID-19 vaccines, as it can be produced locally and at a lower cost, making it a promising candidate for future vaccination strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Immunogenicity of a Newcastle Disease Virus Vector-Based SARS-CoV-2 Vaccine Candidate, AVX/COVID-12-HEXAPRO (Patria), in Pigs. Lara-Puente, JH., Carreño, JM., Sun, W., et al.[2023]

In a study of 395 healthcare workers who received the Oxford/AstraZeneca COVID-19 vaccine, 270 participants (68.4%) reported at least one adverse event, with common symptoms including muscle ache, fatigue, headache, and fever.

No serious adverse events such as hospitalization, disability, or death were reported, indicating that while mild to moderate side effects are common, the vaccine is generally safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of Oxford/AstraZeneca's COVID-19 vaccine among health care workers of Ayder Comprehensive Specialized Hospital, Tigray, Ethiopia. Tequare, MH., Abraha, HE., Adhana, MT., et al.[2022]

A study involving 451 adults showed that inhaled adenovirus-vectored COVID-19 vaccines, including a bivalent and a variant-specific option, were safe and well tolerated, with mostly mild to moderate side effects and no serious adverse events reported.

The bivalent vaccine induced a significantly higher level of neutralizing antibodies against the Omicron variant compared to the standard vaccine, suggesting it may provide enhanced protection against SARS-CoV-2 variants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of heterologous boosting with orally administered aerosolized bivalent adenovirus type-5 vectored COVID-19 vaccine and B.1.1.529 variant adenovirus type-5 vectored COVID-19 vaccine in adults 18 years and older: a randomized, double blinded, parallel controlled trial. Xu, JW., Wang, BS., Gao, P., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Parainfluenza Virus 5 (PIV5)-vectored Intranasal COVID-19 Vaccine as a Single Dose Vaccine and as a Booster against SARS-CoV-2 Variants. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Intranasal immunization with an RBD-hemagglutinin fusion protein harnesses preexisting immunity to enhance antigen-specific responses. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

An intranasal vaccine targeting the receptor binding domain of SARS-CoV-2 elicits a protective immune response. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Intranasal administration of a single dose of MVA-based vaccine candidates against COVID-19 induced local and systemic immune responses and protects mice from a lethal SARS-CoV-2 infection. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Intranasal vaccination with a lentiviral vector protects against SARS-CoV-2 in preclinical animal models. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Adverse Effects of the COVID-19 Vaccine Reported by Lecturers and Staff of Kabul University of Medical Sciences, Kabul, Afghanistan. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Characteristics and Comparison of Adverse Events of Coronavirus Disease 2019 Vaccines Reported to the United States Vaccine Adverse Event Reporting System Between 14 December 2020 and 8 October 2021. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Safety and Immunogenicity of a Newcastle Disease Virus Vector-Based SARS-CoV-2 Vaccine Candidate, AVX/COVID-12-HEXAPRO (Patria), in Pigs. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Adverse events of Oxford/AstraZeneca's COVID-19 vaccine among health care workers of Ayder Comprehensive Specialized Hospital, Tigray, Ethiopia. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of heterologous boosting with orally administered aerosolized bivalent adenovirus type-5 vectored COVID-19 vaccine and B.1.1.529 variant adenovirus type-5 vectored COVID-19 vaccine in adults 18 years and older: a randomized, double blinded, parallel controlled trial. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Single-Dose Intranasal Administration of AdCOVID Elicits Systemic and Mucosal Immunity against SARS-CoV-2 and Fully Protects Mice from Lethal Challenge. [2023]