NCT05991427

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

A Phase I, Randomized, Observer Blind Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Zoster Vaccine (Adenovirus Vector) in Healthy Adults Aged 50-65 Years

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: CanSino Biologics Inc. · Industry
• Sex: All
• Age: 50 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Zoster Vaccine (Adenovirus Vector) (ChAdOx1-VZV)	2 doses of ChAdOX1-VZV vaccine on Day 0 and Month 4
BIOLOGICAL	Zoster Vaccine Recombinant, Adjuvanted (Shingrix)	2 doses of Shingrix vaccine on Day 0 and Month 4
BIOLOGICAL	ChAdOx1-VZV	2 doses of ChAdOX1-VZV vaccine on Day 0 and Month 4
BIOLOGICAL	Shingrix	2 doses of Shingrix vaccine on Day 0 and Month 4
BIOLOGICAL	IH ChAdOx1-VZV	2 doses of ChAdOX1-VZV vaccine on Day 0 and Month 4
BIOLOGICAL	IH saline	2 doses of saline on Day 0 and Month 4

Timeline

• Start date: 2023-11-07
• Primary completion: 2024-11-04
• Completion: 2024-11-04
• First posted: 2023-08-14
• Last updated: 2024-12-04

Locations

1 site across 1 country: Canada