Nasal Spray Vaccine for COVID-19

No longer recruiting at 2 trial locations

Overseen By Hana M El Sahly

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Intranasal medications, Illicit drugs

Disqualifiers: SARS-CoV-2 infection, Pregnancy, Respiratory disease, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and body's reaction to a new nasal spray COVID-19 vaccine, MPV/S-2P, in individuals who have completed a full series and at least one booster of the mRNA COVID-19 vaccine. Researchers seek to understand how people respond to this nasal delivery method. The trial is recruiting healthy adults who are not currently experiencing ongoing health issues, have been vaccinated, and have not recently contracted COVID-19. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative nasal spray vaccine.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that any change in chronic prescription medication should not be due to a deterioration of your condition in the 30 days before the study. Regular use of intranasal medications, including steroids, must be stopped 30 days before and after the study vaccination, and intranasal steroids must not be used for 6 months after vaccination.

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

A previous study tested the MPV/S-2P vaccine on monkeys and found it safe and well-tolerated. It triggered strong immune responses, indicating a positive outcome. The vaccine did not cause serious side effects in these animals. Now, the trial is in the early phase, focusing on ensuring the vaccine's safety for humans. Early phase trials often involve testing in humans for the first time, so while promising data exists from animals, researchers are still collecting information from humans. As a nasal spray vaccine, it might work differently from shots, but current research primarily checks its safety in people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the nasal spray vaccine MPV/S-2P for COVID-19 because it offers a new delivery method compared to the standard injections used for mRNA vaccines like Pfizer-BioNTech's Comirnaty and Moderna's Spikevax. The intranasal administration via the VaxINator device provides a potentially easier and more comfortable way to receive a vaccine, which could improve uptake and accessibility. Additionally, by delivering the vaccine directly to the nasal passages, it might enhance mucosal immunity, which is a critical first line of defense against respiratory viruses. This new approach could lead to better prevention of virus transmission and milder symptoms in those exposed to the virus.

What evidence suggests that this nasal spray vaccine could be effective for COVID-19?

Research has shown that the MPV/S-2P nasal spray vaccine effectively protected monkeys from COVID-19, with just one dose providing strong protection. The vaccine triggered a robust immune response, including the production of antibodies, which help fight infections against the virus causing COVID-19. It may also protect the nose and throat, where the virus often enters. These findings suggest that the vaccine could work well in humans, potentially preventing infection or reducing disease severity. In this trial, participants will receive different dosages of the MPV/S-2P vaccine to evaluate its safety and effectiveness in humans. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Healthy adults aged 18-64 who've completed a COVID-19 mRNA vaccine series and booster at least 16 weeks prior. Must not be pregnant, smoke regularly, or have had SARS-CoV-2 recently. Participants should agree to contraception use, mask-wearing post-vaccination, and no international travel until after Day 29 visit.

Inclusion Criteria

In general good health as determined by medical history and physical examination

Clinical screening laboratory evaluations are within normal reference ranges or grade 1 with no clinical significance

Must agree to have samples stored for secondary research

Exclusion Criteria

Participant who is pregnant or breastfeeding

Has a history of hypersensitivity or severe allergic reaction to any previous licensed or unlicensed vaccine or to the candidate vaccine components

I have not donated blood or plasma in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of MPV/S-2P administered intranasally

1 day

1 visit (in-person)

Safety Review

Safety review of clinical data and virologic shedding data through at least Day 8 by the Safety Review Committee

8 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Periodic visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• MPV/S-2P

Trial Overview The trial tests the safety and immune response of MPV/S-2P intranasal vaccine in adults previously vaccinated with an mRNA COVID-19 vaccine. It's a single-dose study focusing on how well-tolerated the nasal spray is and its effectiveness in boosting immunity.

How Is the Trial Designed?

Group I: Cohort 3 Experimental Treatment 1 Intervention

Healthy adults between 18 - 64 years who have received a primary series and at least one booster with an authorized or licensed mRNA SARS-CoV-2 parenteral vaccine will receive 1 x 10\^6 PFU of MPV/S-2P administered intranasally (approximately 0.5 mL per nostril) using VaxINator (Teleflex) for 1 year. N=20

Group II: Cohort 2 Experimental Treatment 1 Intervention

Healthy adults between 18 - 64 years who have received a primary series and at least one booster with an authorized or licensed mRNA SARS-CoV-2 parenteral vaccine will receive 1 x 10\^5 PFU of MPV/S-2P administered intranasally (approximately 0.5 mL per nostril) using VaxINator (Teleflex) for 1 year. N=20

Group III: Cohort 1 Experimental Treatment 1 Intervention

Healthy adults between 18 - 64 years who have received a primary series and at least one booster with an authorized or licensed mRNA SARS-CoV-2 parenteral vaccine will receive 1 x 10\^4 PFU of MPV/S-2P administered intranasally (approximately 0.5 mL per nostril) using VaxINator (Teleflex) for 1 year. N=20

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Published Research Related to This Trial

The study analyzed over 7.8 million adverse reactions from COVID-19 vaccines (AstraZeneca, Janssen, Moderna, Pfizer-BioNTech) and found a higher risk of serious adverse reactions compared to influenza vaccines, particularly in individuals aged 65 and older.

Serious adverse reactions typically occurred within the first week after vaccination, with the highest relative risks observed for allergic reactions, cardiovascular events, and thrombosis, highlighting the need for further research into the mechanisms behind these reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency and Associations of Adverse Reactions of COVID-19 Vaccines Reported to Pharmacovigilance Systems in the European Union and the United States. Montano, D.[2022]

Citations

1. absolutelymaybe.plos.org absolutelymaybe.plos.org/2025/09/30/the-35th-mucosal-covid-vaccine-in-clinical-trial-an-intranasal-self-amplifying-mrna-vax-and-more-nextgen-vaccine-update-33/

A Big Month for Progress on Mucosal Covid Vaccination ... Phase 1 for MPV/S-2P, the intranasal viral vector vaccine developed by the NIH's National Institute of Allergy and Infectious Diseases (NIAID).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06441968

Safety and Immunogenicity Trial of MPV/S-2P SARS-CoV-2 ... A phase I clinical trial to evaluate the safety, reactogenicity, and immunogenicity of MPV/S-2P administered intranasally to adults

3. withpower.com withpower.com/trial/phase-1-covid-19-5-2024-00a23

Nasal Spray Vaccine for COVID-19 · Info for Participants Research shows that the MPV/S-2P nasal spray vaccine was highly effective in protecting macaques from COVID-19, with one dose providing substantial protection ...

4. mdpi.com mdpi.com/2076-393X/13/1/17

SARS-CoV-2 Evolution: Implications for Diagnosis ... The focus of this review is to provide a comprehensive analysis of the functional impact of mutations on diagnosis, treatments, and vaccine effectiveness.

5. contagionlive.com contagionlive.com/view/could-a-nasal-covid-19-vaccine-offer-differing-benefits-to-subcutaneous-injections-

Could a Nasal COVID-19 Vaccine Offer Differing Benefits ... The MPV/S-2P vaccine has produced robust systemic immune responses, including SARS-CoV-2-directed antibodies, as well as local immunity in ...

6. nih.gov nih.gov/news-events/news-releases/nih-sponsored-trial-nasal-covid-19-vaccine-opens

NIH-sponsored trial of nasal COVID-19 vaccine opens In pre-clinical non-human primate studies, MPV/S-2P was safe and well tolerated. It produced robust systemic immune responses, including SARS- ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06441968

Safety and Immunogenicity Trial of MPV/S-2P SARS-CoV-2 ... A phase I clinical trial to evaluate the safety, reactogenicity, and immunogenicity of MPV/S-2P administered intranasally to adults

8. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X25008990

Review Mucosal COVID-19 vaccines in clinical development Mucosal vaccines are designed to elicit both a strong systemic and mucosal immune response gaining importance as the next generation of ...