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

Primary Purpose

Herpes Zoster

Status
Not yet recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Recombinant Zoster Vaccine (Adenovirus Vector) (ChAdOx1-VZV)
Zoster Vaccine Recombinant, Adjuvanted (Shingrix)
ChAdOx1-VZV
Shingrix
IH ChAdOx1-VZV
IH saline
Sponsored by
CanSino Biologics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Herpes Zoster focused on measuring Varicella zoster virus, Safety, Immunogenicity, Intramuscular injection, Inhalation, Vaccine

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Participants who can understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent Male and female volunteers aged 50 to 65 years at time of informed consent. Healthy or in stable health participants with pre-existing, stable, well-controlled disease, defined as mild disease or medical condition not requiring medical therapy or not requiring a change in medical therapy due to worsening of disease during the 6 months before enrollment may be enrolled at the discretion of the investigator. Female participants of childbearing potential must have a negative urine pregnancy test at screening and before each dose of investigational vaccine and have been using an adequate form of contraception 30 days prior to first dose of investigational vaccine and agree to use adequate contraception for the entire duration of their participation in the study. Male participants must agree to use adequate contraception from the first dose of investigational vaccine until at least 30 days after the last dose of investigational vaccine. Exclusion Criteria: Pregnant or lactating at screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine. History of herpes zoster (HZ) (Shingles) in the past 5 years. Previous vaccination against HZ. History of or present substance abuse as judged by the investigator. Immunosuppression resulting from hematopoietic stem cell transplantation, acquired immunodeficiency syndrome (AIDS) or symptomatic (human immunodeficiency virus) HIV infection. Chronic administration of immunosuppressants (at least 10 mg per day of prednisone equivalent for glucocorticoids) or other immune-modifying drugs within 6 months prior to the first dose of investigational vaccine. Has received any blood products or immunoglobulin within 90 days prior to study injection, or is likely to require infusion of blood products during the study period. Is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of or receiving treatment for cancer within the last 5 years. History of clinically significant thrombocytopenia or other clotting disorders. Serious cardiovascular disease (pulmonary heart disease, pulmonary edema, hypertension that cannot be controlled by medication (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg)), serious liver and kidney disease, and diabetes mellitus with complications. History of allergic skin diseases. Use of any investigational or non-registered product (drug or vaccine) within 30 days before the first dose of investigational vaccine/product, or planned use during the study period. Receipt of any other immunizations within one month before the first dose of investigational vaccine (2 weeks in the case of inactivated influenza vaccines or other non-replicating immunization products [e.g., tetanus and reduced dose diphtheria toxoid (dT) vaccine, pneumococcal vaccine, hepatitis A vaccine, hepatitis B vaccine]), or scheduled within 30 days after last dose of investigational vaccine. Received a vaccine with adenovirus vector within 6 months prior to the first dose of investigational vaccine. Investigator site staff directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members. Volunteers with or have history of lung function abnormalities such as asthma, chronic obstructive pulmonary disease, and pulmonary fibrosis. Current smokers. History or current evidence of any condition, therapy, or laboratory abnormal values that are clinically significant which might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participants to participate, in the opinion of the treating investigator.

Sites / Locations

  • Canadian Center for Vaccinology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Placebo Comparator

Arm Label

Experimental vaccine group, low dose, Intramuscular injection(IM)

Control vaccine group, low dose, IM

Experimental vaccine group, high dose, IM

Control vaccine group, high dose, IM

Experimental vaccine group, Aerosol, Inhalation(IH)

Saline group, Aerosol, IH

Arm Description

2 doses of ChAdOX1-VZV vaccine (1 × 10^10 vp) on Day 0 and Month 4

2 doses of Shingrix vaccine (0.5ml) on Day 0 and Month 4

2 doses of ChAdOX1-VZV vaccine (5 × 10^10 vp) on Day 0 and Month 4

2 doses of Shingrix vaccine (0.5ml) on Day 0 and Month 4

2 doses of ChAdOX1-VZV vaccine (2 × 10^10 vp) on Day 0 and Month 4

2 doses of saline (0.2ml) on Day 0 and Month 4

Outcomes

Primary Outcome Measures

Incidence of local and systemic reactogenicity 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.

Secondary Outcome Measures

The unsolicited adverse events for 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.
The Geometric mean titer (GMT) of gE-specific antibody using Enzyme-linked Immunosorbent Assay (ELISA) over the time course.
The GMT of gE-specific antibody 28 days after the 1st and 2nd dose vaccination across each vaccination group.
The gE-specific IFN-γ by EliSpot over the time course of the study

Full Information

First Posted
July 28, 2023
Last Updated
October 19, 2023
Sponsor
CanSino Biologics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05991427
Brief Title
A Study to Evaluate the Safety and Immunogenicity of ChAdOx1-VZV in Healthy Adults Aged 50-65 Years
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CanSino Biologics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster
Keywords
Varicella zoster virus, Safety, Immunogenicity, Intramuscular injection, Inhalation, Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental vaccine group, low dose, Intramuscular injection(IM)
Arm Type
Experimental
Arm Description
2 doses of ChAdOX1-VZV vaccine (1 × 10^10 vp) on Day 0 and Month 4
Arm Title
Control vaccine group, low dose, IM
Arm Type
Active Comparator
Arm Description
2 doses of Shingrix vaccine (0.5ml) on Day 0 and Month 4
Arm Title
Experimental vaccine group, high dose, IM
Arm Type
Experimental
Arm Description
2 doses of ChAdOX1-VZV vaccine (5 × 10^10 vp) on Day 0 and Month 4
Arm Title
Control vaccine group, high dose, IM
Arm Type
Active Comparator
Arm Description
2 doses of Shingrix vaccine (0.5ml) on Day 0 and Month 4
Arm Title
Experimental vaccine group, Aerosol, Inhalation(IH)
Arm Type
Experimental
Arm Description
2 doses of ChAdOX1-VZV vaccine (2 × 10^10 vp) on Day 0 and Month 4
Arm Title
Saline group, Aerosol, IH
Arm Type
Placebo Comparator
Arm Description
2 doses of saline (0.2ml) on Day 0 and Month 4
Intervention Type
Biological
Intervention Name(s)
Recombinant Zoster Vaccine (Adenovirus Vector) (ChAdOx1-VZV)
Intervention Description
2 doses of ChAdOX1-VZV vaccine on Day 0 and Month 4
Intervention Type
Biological
Intervention Name(s)
Zoster Vaccine Recombinant, Adjuvanted (Shingrix)
Intervention Description
2 doses of Shingrix vaccine on Day 0 and Month 4
Intervention Type
Biological
Intervention Name(s)
ChAdOx1-VZV
Intervention Description
2 doses of ChAdOX1-VZV vaccine on Day 0 and Month 4
Intervention Type
Biological
Intervention Name(s)
Shingrix
Intervention Description
2 doses of Shingrix vaccine on Day 0 and Month 4
Intervention Type
Biological
Intervention Name(s)
IH ChAdOx1-VZV
Intervention Description
2 doses of ChAdOX1-VZV vaccine on Day 0 and Month 4
Intervention Type
Biological
Intervention Name(s)
IH saline
Intervention Description
2 doses of saline on Day 0 and Month 4
Primary Outcome Measure Information:
Title
Incidence of local and systemic reactogenicity within 7 days after each vaccination
Time Frame
Within 7 days after each vaccination
Title
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
Secondary Outcome Measure Information:
Title
The unsolicited adverse events for 28 days after each vaccination
Time Frame
28 days after each vaccination
Title
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
Title
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
Title
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
Title
The gE-specific IFN-γ by EliSpot over the time course of the study
Time Frame
Through study completion, an average of 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants who can understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent Male and female volunteers aged 50 to 65 years at time of informed consent. Healthy or in stable health participants with pre-existing, stable, well-controlled disease, defined as mild disease or medical condition not requiring medical therapy or not requiring a change in medical therapy due to worsening of disease during the 6 months before enrollment may be enrolled at the discretion of the investigator. Female participants of childbearing potential must have a negative urine pregnancy test at screening and before each dose of investigational vaccine and have been using an adequate form of contraception 30 days prior to first dose of investigational vaccine and agree to use adequate contraception for the entire duration of their participation in the study. Male participants must agree to use adequate contraception from the first dose of investigational vaccine until at least 30 days after the last dose of investigational vaccine. Exclusion Criteria: Pregnant or lactating at screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine. History of herpes zoster (HZ) (Shingles) in the past 5 years. Previous vaccination against HZ. History of or present substance abuse as judged by the investigator. Immunosuppression resulting from hematopoietic stem cell transplantation, acquired immunodeficiency syndrome (AIDS) or symptomatic (human immunodeficiency virus) HIV infection. Chronic administration of immunosuppressants (at least 10 mg per day of prednisone equivalent for glucocorticoids) or other immune-modifying drugs within 6 months prior to the first dose of investigational vaccine. Has received any blood products or immunoglobulin within 90 days prior to study injection, or is likely to require infusion of blood products during the study period. Is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of or receiving treatment for cancer within the last 5 years. History of clinically significant thrombocytopenia or other clotting disorders. Serious cardiovascular disease (pulmonary heart disease, pulmonary edema, hypertension that cannot be controlled by medication (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg)), serious liver and kidney disease, and diabetes mellitus with complications. History of allergic skin diseases. Use of any investigational or non-registered product (drug or vaccine) within 30 days before the first dose of investigational vaccine/product, or planned use during the study period. Receipt of any other immunizations within one month before the first dose of investigational vaccine (2 weeks in the case of inactivated influenza vaccines or other non-replicating immunization products [e.g., tetanus and reduced dose diphtheria toxoid (dT) vaccine, pneumococcal vaccine, hepatitis A vaccine, hepatitis B vaccine]), or scheduled within 30 days after last dose of investigational vaccine. Received a vaccine with adenovirus vector within 6 months prior to the first dose of investigational vaccine. Investigator site staff directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members. Volunteers with or have history of lung function abnormalities such as asthma, chronic obstructive pulmonary disease, and pulmonary fibrosis. Current smokers. History or current evidence of any condition, therapy, or laboratory abnormal values that are clinically significant which might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participants to participate, in the opinion of the treating investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meixu Yan
Phone
022-58213600-6051
Email
meixu.yan@cansinotech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scot Halperin, MD
Organizational Affiliation
Canadian Center for Vaccinology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Canadian Center for Vaccinology
City
Halifax
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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