Nasal Spray Vaccine for COVID-19

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

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

No Placebo Group

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.

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

+8 more

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

+18 more

Participant Groups

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.

3Treatment groups

Experimental Treatment

Group I: Cohort 3Experimental Treatment1 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 2Experimental Treatment1 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 1Experimental Treatment1 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