drugset / Trial / NCT05991427
A Study to Evaluate the Safety and Immunogenicity of ChAdOx1-VZV in Healthy Adults Aged 50-65 Years
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This is a randomized, observer blind and controlled study. Participants in low-dose and high-dose IM group will be randomized in a ratio of 2:1 to receive either the investigational product or the control. Participants in the IH group will receive either inhaled investigational product or saline in a ratio of 3:1. Enrollment will be in an ascending order of dosage groups. All participants will receive 2 doses in 4 months interval. Blood samples will be collected for immunogenicity evaluation over the time course of the study.
Timeline
- Start
- 2023-11-07
- Primary completion
- 2024-11-04
- Completion
- 2024-11-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ChAdOX1-VZV | Vaccine | 1e+10 unknown | Intramuscular |
| Subject | ChAdOX1-VZV | Vaccine | 2e+10 unknown | Intramuscular |
| Subject | ChAdOX1-VZV | Vaccine | 5e+10 unknown | Intramuscular |
| Comparator | VARICELLA ZOSTER VIRUS ENVELOPE GLYCOPROTEIN E | Vaccine | 0.5 ml | Intramuscular |