Nasal Spray Vaccine for COVID-19

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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

A clinical trial to evaluate the safety, reactogenicity, and immunogenicity of MPV/S-2P administered intranasally to adults who have previously received a primary series and at least one booster with an authorized or licensed mRNA SARS-CoV-2 parenteral vaccine. The primary objective is to evaluate the safety and reactogenicity of a single dose of MPV/S-2P in previously vaccinated healthy adults.

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.

What data supports the effectiveness of the nasal spray vaccine treatment MPV/S-2P for COVID-19?

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 and two doses fully preventing the virus from replicating in the airways. This suggests that the treatment could be very effective in preventing COVID-19 infection and spread. ^{1 2 3 4 5}

Is the nasal spray vaccine for COVID-19 safe for humans?

The nasal spray vaccine for COVID-19 has been tested in early human trials and found to be safe, with no participants discontinued due to adverse events. It showed moderate immune response, suggesting it is generally safe for further development. ^{4 6 7 8 9}

How is the nasal spray vaccine MPV/S-2P different from other COVID-19 treatments?

The nasal spray vaccine MPV/S-2P is unique because it is administered through the nose, which helps build immunity right where the virus enters the body. This method can block the virus from spreading and is different from most COVID-19 vaccines that are given as shots in the arm. ^{1 5 10 11 12}

Eligibility Criteria

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

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

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Mucosal prime-boost immunization with live murine pneumonia virus-vectored SARS-CoV-2 vaccine is protective in macaques. [2023]

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

A two-adjuvant multiantigen candidate vaccine induces superior protective immune responses against SARS-CoV-2 challenge. [2023]

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

Two-component spike nanoparticle vaccine protects macaques from SARS-CoV-2 infection. [2023]

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

Intranasal nanoemulsion adjuvanted S-2P vaccine demonstrates protection in hamsters and induces systemic, cell-mediated and mucosal immunity in mice. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

An Intranasal OMV-Based Vaccine Induces High Mucosal and Systemic Protecting Immunity Against a SARS-CoV-2 Infection. [2022]

6. Switzerland 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. [2022]

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

Safety and immunogenicity of a live recombinant Newcastle disease virus-based COVID-19 vaccine (Patria) administered via the intramuscular or intranasal route: Interim results of a non-randomized open label phase I trial in Mexico. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A Phase 1, Randomized, Double-Blinded, Placebo-Controlled and Dose-Escalation Study to Evaluate the Safety and Immunogenicity of the Intranasal DelNS1-nCoV-RBD LAIV for COVID-19 in Healthy Adults. [2023]

9. 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]

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

A nasal omicron vaccine booster elicits potent neutralizing antibody response against emerging SARS-CoV-2 variants. [2022]

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

A Pilot Study of 0.4% Povidone-Iodine Nasal Spray to Eradicate SARS-CoV-2 in the Nasopharynx. [2023]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Intranasal Single-Replication Influenza Vector Induces Cross-Reactive Serum and Mucosal Antibodies against SARS-CoV-2 Variants. [2023]