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Virus Therapy

Nasal Spray Vaccine for COVID-19

Phase 1

Recruiting

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Receipt of a complete primary COVID-19 mRNA vaccine series and at least one mRNA booster with last vaccination at least 16 weeks prior to study vaccination

Non-pregnant adults, 18-64 years of age at time of vaccination

Must not have

Regular use of intranasal medications including steroids

Abnormal vital signs (Grade 1 or higher)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 29

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test the safety and effectiveness of giving a nasal spray vaccine to adults who have already received an mRNA COVID-19 vaccine. The main goal is to see if the nasal spray vaccine is

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, typical reactions may include local nasal irritation or discomfort, potential systemic responses like fever or fatigue, and other common vaccination-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've completed the primary COVID-19 mRNA vaccine series and received one booster, with the last shot over 16 weeks ago.

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I am between 18 and 64 years old and not pregnant.

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I do not smoke or only smoke occasionally.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I regularly use nasal sprays, including steroids.

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My vital signs are not normal.

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I have a weak immune system or have been on drugs that weaken it.

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I have a serious condition affecting my nose or upper airways.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 29

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 29

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 29 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Percentage of participants who seroconverted

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 7Eligibility criteria met