drugset / Trial / NCT05991427

A Study to Evaluate the Safety and Immunogenicity of ChAdOx1-VZV in Healthy Adults Aged 50-65 Years

NCT05991427

Phase 1 Completed 65 enrolled CanSino Biologics Inc.
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

EvaluationDrugModalityDoseRoute
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

Indications