Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental vaccine group, low dose, Intramuscular injection(IM) | Experimental | 2 doses of ChAdOX1-VZV vaccine (1 × 10^10 vp) on Day 0 and Month 4 |
|
| Control vaccine group, low dose, IM | Active Comparator | 2 doses of Shingrix vaccine (0.5ml) on Day 0 and Month 4 |
|
| Experimental vaccine group, high dose, IM | Experimental | 2 doses of ChAdOX1-VZV vaccine (5 × 10^10 vp) on Day 0 and Month 4 |
|
| Control vaccine group, high dose, IM | Active Comparator | 2 doses of Shingrix vaccine (0.5ml) on Day 0 and Month 4 |
|
| Experimental vaccine group, Aerosol, Inhalation(IH) | Experimental | 2 doses of ChAdOX1-VZV vaccine (2 × 10^10 vp) on Day 0 and Month 4 |
|
| Saline group, Aerosol, IH |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Zoster Vaccine (Adenovirus Vector) (ChAdOx1-VZV) | Biological | 2 doses of ChAdOX1-VZV vaccine on Day 0 and Month 4 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of local and systemic reactogenicity within 7 days after each vaccination | 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. | From the 1st dose to the end of study |
| Measure | Description | Time Frame |
|---|---|---|
| The unsolicited adverse events for 28 days after each vaccination | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Scot Halperin, MD | Canadian Center for Vaccinology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canadian Center for Vaccinology | Halifax | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo Comparator |
2 doses of saline (0.2ml) on Day 0 and Month 4 |
|
| Zoster Vaccine Recombinant, Adjuvanted (Shingrix) | Biological | 2 doses of Shingrix vaccine on Day 0 and Month 4 |
|
| ChAdOx1-VZV | Biological | 2 doses of ChAdOX1-VZV vaccine on Day 0 and Month 4 |
|
| Shingrix | Biological | 2 doses of Shingrix vaccine on Day 0 and Month 4 |
|
| IH ChAdOx1-VZV | Biological | 2 doses of ChAdOX1-VZV vaccine on Day 0 and Month 4 |
|
| IH saline | Biological | 2 doses of saline on Day 0 and Month 4 |
|
| Day 7 post each vaccination |
| The Geometric mean titer (GMT) of gE-specific antibody using Enzyme-linked Immunosorbent Assay (ELISA) over the time course. | 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. | 28 days after the 1st and 2nd dose vaccination |
| The gE-specific IFN-γ by EliSpot over the time course of the study | Through study completion, an average of 8 months |
| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| D002644 | Chickenpox |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided