Intranasal COVID Vaccine for COVID-19

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new COVID-19 vaccine, CVXGA1, administered nasally to evaluate its effectiveness in boosting the body's immune response and its safety. Participants will receive either the experimental nasal vaccine or a placebo (a harmless substance resembling the treatment) for comparison. It suits individuals who are generally healthy, have not received a COVID vaccine or had an infection in the last 150 days, and do not have breathing issues or severe allergies. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that CVXGA1 is likely to be safe for humans?

Research has shown that the intranasal COVID-19 vaccine, CVXGA1, is generally safe for people. Early results indicate it is well-tolerated, with only minor side effects. Studies have found that this vaccine triggers a strong immune response, suggesting its effectiveness. In earlier studies, participants reported no serious side effects after receiving the vaccine. This makes it a promising option for those who prefer a needle-free vaccination method. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about CVXGA1 because it offers a unique intranasal delivery method for combating COVID-19, unlike the standard vaccines that are delivered via injection. This nasal spray aims to stimulate an immune response directly in the respiratory tract, potentially providing more immediate protection where the virus enters the body. Additionally, the single-dose format could simplify administration and improve vaccine accessibility and compliance.

What evidence suggests that this treatment might be an effective treatment for COVID-19?

Research shows that CVXGA1, a nasal spray COVID-19 vaccine, looks promising. In this trial, participants will receive either the CVXGA1 vaccine or a placebo. Studies have found that CVXGA1 helps the body fight the virus by creating a strong immune response. It also appears safe, with only minor side effects reported. Early results suggest it could serve as a booster to enhance protection against COVID-19. Overall, the evidence supports its potential as an effective option for preventing COVID-19. ^{2 3 6 7 8}

Who Is on the Research Team?

Hong Jin

Principal Investigator

CyanVac LLC

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

Citations

1. science.org science.org/doi/10.1126/sciadv.adw0896

vectored COVID-19 vaccine in adults and teens in an open ... The data indicate that CVXGA1 is a potentially effective intranasal COVID-19 vaccine that is immunogenic with minimal reactogenicity.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40614182/

vectored COVID-19 vaccine in adults and teens in an open ... The data indicate that CVXGA1 is a potentially effective intranasal COVID-19 vaccine that is immunogenic with minimal reactogenicity.

3. journals.asm.org journals.asm.org/doi/10.1128/jvi.01989-24

Efficacy of parainfluenza virus 5 (PIV5)-vectored intranasal ... Our data suggest that CVXGA1, and other PIV5-vectored COVID-19 vaccines, can serve as an effective heterologous booster to offer long ...

4. biospace.com biospace.com/press-releases/blue-lake-and-cyanvac-publish-full-data-from-open-label-phase-1-clinical-study-of-covid-19-vaccine-candidate

Blue Lake and CyanVac Publish Full Data from Open ... Results of the study demonstrate CVXGA's potential to be a safe, immunogenic and effective vaccine against COVID-19. The study, entitled “Safety ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05736835?term=intranasal%20vaccine&cond=COVID-19&viewType=Table&rank=6

A Phase 2 Trial of the Immunogenicity and Safety ... This is a randomized, placebo controlled, blinded study to evaluate the immunogenicity and safety of CVXGA. Trial Population: Up to 400 healthy adults ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12227042/

Safety and immunogenicity of intranasal parainfluenza ... The data indicate that CVXGA1 is a potentially effective intranasal COVID-19 vaccine that is immunogenic with minimal reactogenicity. PIV5- ...

7. bluelakebiotechnology.com bluelakebiotechnology.com/news/preclinical-intranasal-covid-19-vaccine-candidate-data-demonstrate-durable-immune-response-and-broad-protection

Preclinical Intranasal COVID-19 Vaccine Candidate Data ... “These studies provide compelling evidence that intranasal vaccination with CVXGA not only induces long-lasting immune responses but also serves ...

8. scienceblog.cincinnatichildrens.org scienceblog.cincinnatichildrens.org/nasal-covid-vax-shows-promise-in-phase-1-clinical-trial/

Nasal COVID Vax Shows Promise in Phase 1 Clinical Trial A nasal vaccine could prove both more effective medically and more tolerable for young children and adults who may fear needles.