Trials / Unknown
UnknownNCT04798001
Safety and Immunogenicity of an Intranasal RSV Vaccine Expressing SARS-CoV-2 Spike Protein (COVID-19 Vaccine) in Adults
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
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- Sponsor
- Meissa Vaccines, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 69 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 1, Single Dose, Intranasal Drops | Single intranasal dose on Day 1, by intranasal drops |
| BIOLOGICAL | Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 2, Single Dose, Intranasal Drops | Single intranasal dose on Day 1, by intranasal drops |
| BIOLOGICAL | Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Single Dose, Intranasal Drops | Single intranasal dose on Day 1, by intranasal drops |
| BIOLOGICAL | Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Two Doses, Intranasal Drops | Intranasal dose on Day 1 by intranasal drops. Followed by a second, identical dose on Day 36 by intranasal drops |
| BIOLOGICAL | Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Single Dose, Intranasal Spray | Single intranasal dose on Day 1, by intranasal spray |
Timeline
- Start date
- 2021-04-12
- Primary completion
- 2022-10-31
- Completion
- 2022-10-31
- First posted
- 2021-03-15
- Last updated
- 2022-08-02
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04798001. Inclusion in this directory is not an endorsement.