Publication date: Feb 10, 2025
This Phase I/II trial in France evaluates safety and immunogenicity of a booster dose of an intranasal COVID-19 vaccine (LVT-001) versus a booster dose of a COVID-19 mRNA vaccine (Pfizer-BioNTech) in healthy adult volunteers. As a first-in-human trial, Phase I will assess the safety and immunogenicity of three escalating doses of the LVT-001 vaccine across 3 cohorts of 12 volunteers per dose level. Based on cumulative data collected up to Day 28 visit from the last included participant in the Phase I, the go/no-go decision for Phase II and selection of the optimal dose will be performed. Phase II will then evaluate the immunogenicity of the selected intranasal dose of LVT-001 vaccine, compared to the standard of care of intramuscular COVID-19 mRNA Pfizer-BioNTech booster.
| Concepts | Keywords |
|---|---|
| 30kg | COVID-19 |
| Pcr | Healthy |
| Rhinitis | intranasal |
| Tutorship | Nasal |
| Vaccine | vaccine |
Semantics
| Type | Source | Name |
|---|---|---|
| disease | MESH | COVID-19 |
| disease | MESH | general health |
| disease | IDO | history |
| pathway | REACTOME | SARS-CoV-2 Infection |
| disease | IDO | blood |
| disease | MESH | respiratory infections |
| disease | MESH | gastroenteritis |
| disease | MESH | contraindication |
| disease | MESH | rhinitis |
| disease | MESH | cleft palate |
| disease | MESH | nasal polyps |
| disease | MESH | epistaxis |
| drug | DRUGBANK | Ethanol |
| disease | MESH | influenza |
| disease | MESH | allergic reaction |
| disease | MESH | hepatitis B |
| pathway | KEGG | Hepatitis B |
| drug | DRUGBANK | Hepatitis B Vaccine (Recombinant) |
| disease | MESH | anaphylactic reaction |
| disease | MESH | angioedema |
| drug | DRUGBANK | Chorionic Gonadotropin (Human) |
| disease | MESH | cancer |
| drug | DRUGBANK | Prednisone |
| disease | MESH | psychiatric disorders |
| disease | MESH | chronic illness |
| disease | MESH | Emerging Infectious Diseases |