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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
65
2 doses of ChAdOX1-VZV vaccine on Day 0 and Month 4
2 doses of Shingrix vaccine on Day 0 and Month 4
2 doses of ChAdOX1-VZV vaccine on Day 0 and Month 4
Canadian Center for Vaccinology
Halifax, Canada
Incidence of local and systemic reactogenicity within 7 days after each vaccination
Time frame: Within 7 days after each vaccination
Incidence of Serious Adverse Event (SAE) and Adverse Event of Special Interest (AESI) from the 1st dose to the end of study.
Time frame: From the 1st dose to the end of study
The unsolicited adverse events for 28 days after each vaccination
Time frame: 28 days after each vaccination
The blood biochemistry parameters, include Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), on day 7 post each vaccination.
Time frame: Day 7 post each vaccination
The Geometric mean titer (GMT) of gE-specific antibody using Enzyme-linked Immunosorbent Assay (ELISA) over the time course.
Time frame: Through study completion, an average of 8 months
The GMT of gE-specific antibody 28 days after the 1st and 2nd dose vaccination across each vaccination group.
Time frame: 28 days after the 1st and 2nd dose vaccination
The gE-specific IFN-γ by EliSpot over the time course of the study
Time frame: Through study completion, an average of 8 months
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2 doses of Shingrix vaccine on Day 0 and Month 4
2 doses of ChAdOX1-VZV vaccine on Day 0 and Month 4
2 doses of saline on Day 0 and Month 4