Safety and Immunogenicity of an Intranasal RSV Vaccine Expressing SARS-CoV-2 Spike Protein (COVID-19 Vaccine) in Adults
Public ClinicalTrials.gov record NCT04798001. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 1, Open-Label, Dose-Escalation Study to Evaluate Tolerability, Safety, and Immunogenicity of an Intranasal Live Attenuated Respiratory Syncytial Virus Vaccine Expressing Spike Protein of SARS-CoV-2 in Healthy Adults Ages 18 - 69 Years
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study evaluates an investigational vaccine that is designed to protect humans against infection with SARS-CoV-2, the novel coronavirus causing COVID-19 disease. The investigational vaccine, MV-014-212, is a live attenuated vaccine against respiratory syncytial virus (RSV) that is expressing the spike (S) protein of SARS-CoV-2. MV-014-212 is administered as drops or a spray in the nose. Specifically, this study analyzes the safety of, and the immune response to, the vaccine when administered to healthy adults between the ages of 18 and 69 years who are seronegative to SARS-CoV-2 and have not received a prior vaccine against COVID-19.
Study identification
- NCT ID
- NCT04798001
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 130 participants
Conditions and interventions
Conditions
Interventions
- Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 1, Single Dose, Intranasal Drops Biological
- Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 2, Single Dose, Intranasal Drops Biological
- Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Single Dose, Intranasal Drops Biological
- Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Two Doses, Intranasal Drops Biological
- Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Single Dose, Intranasal Spray Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 69 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 11, 2021
- Primary completion
- Oct 30, 2022
- Completion
- Oct 30, 2022
- Last update posted
- Aug 1, 2022
2021 – 2022
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Johnson County Clin-Trials | Lenexa | Kansas | 66219 | Recruiting |
| Wake Research | Raleigh | North Carolina | 27612 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04798001, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 1, 2022 · Synced Sep 12, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04798001 live on ClinicalTrials.gov.