drugset / Trial / NCT06294262
Safety, Tolerability, Immunogenicity and Immunological Mechanisms of TETRALITE, a Novel Seasonal Influenza Vaccine
Phase 1/2
Unknown
84 enrolled
LiteVax BV
HarmonyCR, Melle, Belgium · collabUniversity Hospital, Ghent · collab
RandomizedParallel-groupTriple-blindPrevention
Summary
The effect of LiteVax Adjuvant supplemented to licensed seasonal influenza vaccine on safety and immunogenicity will be investigated in both younger and older healthy participants. Local and systemic adverse events, and humoral and cellular immune responses will be determined at different time intervals after a single administration. Mode of action of LiteVax Adjuvant will examined by detailed genetic analysis and omics approaches such as transcriptomics, proteomics and metabolomics.
Timeline
- Start
- 2024-01-29
- Primary completion
- 2024-09
- Completion
- 2025-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LiteVax Adjuvant | Unknown | 0.5 mg | Intramuscular |
| Subject | LiteVax Adjuvant | Unknown | 1 mg | Intramuscular |
| Subject | VaxigripTetra | Vaccine | 15 ug | Intramuscular |