drugset / Trial / NCT05769049
The Safety and Immunogenicity Study of the Recombinant Zoster Vaccine (CHO Cell)
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This is a randomized, observer-blinded, active-controlled Phase I study to evaluate the safety, reactogenicity, and immunogenicity of REC610, when administered as 2 intramuscular (IM) injections in healthy adults aged 40 years and older, who do not have known HZ and history of varicella or HZ vaccination. The recombinant HZ vaccine, Shingrix® (GlaxoSmithKline), will be used as the active control.
Timeline
- Start
- 2023-02-09
- Primary completion
- 2023-12-06
- Completion
- 2023-12-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Recombinant Zoster Vaccine (CHO Cell) | Vaccine | 50 ug | Intramuscular |
| Comparator | VARICELLA ZOSTER VIRUS ENVELOPE GLYCOPROTEIN E | Vaccine | 50 ug | Intramuscular |