Nasal Spray Vaccine for Coronavirus

Recruiting at 1 trial location

Overseen By Skylight Health Research Colorado Springs

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: CastleVax Inc.

Must not be taking: Immunosuppressants, Glucocorticoids, Monoclonal antibodies, others

Disqualifiers: Acute illness, COVID-19 positive, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 3

Duration: 1 day

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new nasal spray vaccine for COVID-19 to determine its safety and tolerance compared to a standard mRNA vaccine. Researchers aim to discover if this nasal spray (NDV-HXP-S-KP.2) serves as a suitable alternative for individuals who have completed their initial COVID-19 vaccination series. Those vaccinated for COVID-19 over six months ago and with a condition that increases the risk for severe COVID-19 might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop taking my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, certain medications that affect the immune system or are taken intranasally may need to be paused, so it's best to discuss your specific medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the NDV-HXP-S-KP.2 nasal spray vaccine is generally safe and easy to handle. Early results found that people who used it experienced mild side effects, such as a runny nose or slight discomfort, similar to other flu vaccines. One study found that even one or two doses of the vaccine offered good protection against the virus without causing serious problems. Another study confirmed the vaccine's safety as a booster, with participants experiencing only mild reactions. This evidence suggests that the nasal spray is safe for people based on past trials. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer a unique approach to COVID-19 vaccination through nasal delivery. Unlike standard COVID-19 vaccines, which are typically administered via intramuscular injection, the NDV-HXP-S-KP.2 vaccine is delivered as a nasal spray. This method could stimulate a strong immune response directly in the respiratory tract, potentially providing more effective protection against the virus where it first enters the body. Additionally, this nasal spray could be easier to administer and might improve vaccine uptake, especially among those hesitant about needles.

What evidence suggests that this trial's treatments could be effective for coronavirus?

Research has shown that the NDV-HXP-S-KP.2 nasal spray vaccine, which trial participants may receive, could help protect against COVID-19. Animal studies, including those on Syrian hamsters and mice, found that this vaccine protected them from the Delta and Omicron variants. The vaccine uses a modified virus to help the body recognize and fight COVID-19. Early results suggest it is safe and well-tolerated as a booster. The vaccine may offer broad protection, potentially guarding against different forms of the virus. ^{1 3 4 5 6}

Who Is on the Research Team?

Michael Egan, PhD

Principal Investigator

CastleVax Inc.

Are You a Good Fit for This Trial?

This trial is for adults who have already received a COVID-19 vaccine. The study aims to test the safety of a new mucosal vaccine compared to an approved mRNA COVID-19 vaccine.

Inclusion Criteria

Is medically stable, as determined by the site investigator (based on review of health status, vital signs, medical history, and physical examination)

Agrees to not participate in any other SARS-CoV-2 infection prevention trial (vaccine, drug, biologic, pre-exposure prophylaxis [PrEP]) during participation in the study

Is available for all study visits, willing to participate in all study procedures, and not planning to relocate from the area for the duration of the study

Exclusion Criteria

Has had a positive COVID-19 test within the 90 days prior to Screening or study vaccination

Current or planned participation in any other interventional clinical trial

Participation in research involving any investigational product within 45 days prior to Screening or study vaccination

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the NDV-HXP-S-KP.2 vaccine intranasally or an approved mRNA COVID-19 vaccine intramuscularly

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, and immune response after vaccination

180 days

Multiple visits (in-person and virtual) at Days 2, 8, 14, 31, 91, and 181

What Are the Treatments Tested in This Trial?

Interventions

• COVID-19 mRNA Vaccine
• NDV-HXP-S-KP.2

Trial Overview The trial is testing NDV-HXP-S-KP.2, a Newcastle Disease Virus-based mucosal vaccine, against an existing systemic mRNA COVID-19 vaccine in a double-blind, randomized setup where neither participants nor researchers know who gets which until after the data is collected.

How Is the Trial Designed?

Group I: IN administration of study drug plus placebo via IM Experimental Treatment 1 Intervention

Nasal Administration of NDV-HXP-S-KP.2 and administration of placebo via Intramuscular Injection

Group II: IN administration of placebo plus COVID-19 vaccine via IM Active Control 1 Intervention

Nasal Administration of Placebo plus administration of COVID-19 mRNA vaccine via Intramuscular Injection

Who Is Running the Clinical Trial?

CastleVax Inc.

Lead Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11116387/

Intranasal vaccination with an NDV-vectored SARS-CoV-2 ... When delivered intranasally, NDV-PFS protected both Syrian hamsters and K18 mice against Delta and Omicron SARS-CoV-2 variants of concern.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07215520

Safety and Tolerability of a Newcastle Disease Virus ... Safety and tolerability of the NDV-HXP-S-KP.2 vaccine given intranasally and an approved mRNA COVID-19 vaccine given intramuscularly will be assessed in ...

3. nature.com nature.com/articles/s44298-024-00043-3

Beyond COVID-19: the promise of next-generation ... NDV-HXP-S, a recombinant Newcastle disease virus-based vaccine, which expresses HexaPro S, has shown enhanced neutralizing and binding ...

4. mountsinai.org mountsinai.org/about/newsroom/2023/promising-results-of-next-generation-intranasal-covid-booster-vaccine-implications-for-infection-prevention-and-transmission

Promising Results of Next-Generation Intranasal COVID-19 ... “The initial observations from our phase 1 trial of NDV-HXP-S as a COVID-19 booster vaccination suggest that it is safe and well-tolerated when delivered ...

5. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2025.1524477/full

Mucosal multivalent NDV-based vaccine provides cross- ... A mucosal multivalent live NDV-HXP-S vaccine shows great promise as a safe, next-generation vaccine conferring broad mucosal and systemic immunity against ...

6. withpower.com withpower.com/trial/phase-2-covid-19-9-2025-ac6eb

Nasal Spray Vaccine for Coronavirus This Phase 2 medical study run by CastleVax Inc. is evaluating whether COVID-19 mRNA Vaccine and NDV-HXP-S-KP.2 will have tolerable side effects & efficacy ...