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

NCT05991427 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2024-12-04

No results posted yet for this study

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

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

Recombinant Zoster Vaccine (Adenovirus Vector) (ChAdOx1-VZV)

2 doses of ChAdOX1-VZV 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

Sponsors & Collaborators

  • CanSino Biologics Inc.

    lead INDUSTRY

Principal Investigators

  • Scot Halperin, MD · Canadian Center for Vaccinology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-07
Primary Completion
2024-11-04
Completion
2024-11-04

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05991427 on ClinicalTrials.gov