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

NCT05991427 | Completed Phase 1

• 1 other identifier: CTP-CVE-001
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Herpes Zoster

Keywords

Varicella zoster virus; Safety; Immunogenicity; Intramuscular injection; Inhalation; Vaccine

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• 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.

  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

Study Arms (6)

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

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

Control vaccine group, low dose, IM

ACTIVE COMPARATOR

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

Biological: Zoster Vaccine Recombinant, Adjuvanted (Shingrix)

Experimental vaccine group, high dose, IM

EXPERIMENTAL

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

Biological: ChAdOx1-VZV

Control vaccine group, high dose, IM

ACTIVE COMPARATOR

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

Biological: Shingrix

Experimental vaccine group, Aerosol, Inhalation(IH)

EXPERIMENTAL

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

Biological: IH ChAdOx1-VZV

Saline group, Aerosol, IH

PLACEBO COMPARATOR

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

Biological: IH saline

Interventions

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

2 doses of ChAdOX1-VZV vaccine on Day 0 and Month 4

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

Zoster Vaccine Recombinant, Adjuvanted (Shingrix) BIOLOGICAL

2 doses of Shingrix vaccine on Day 0 and Month 4

Control vaccine group, low dose, IM

ChAdOx1-VZV BIOLOGICAL

2 doses of ChAdOX1-VZV vaccine on Day 0 and Month 4

Experimental vaccine group, high dose, IM

Shingrix BIOLOGICAL

2 doses of Shingrix vaccine on Day 0 and Month 4

Control vaccine group, high dose, IM

IH ChAdOx1-VZV BIOLOGICAL

2 doses of ChAdOX1-VZV vaccine on Day 0 and Month 4

Experimental vaccine group, Aerosol, Inhalation(IH)

IH saline BIOLOGICAL

2 doses of saline on Day 0 and Month 4

Saline group, Aerosol, IH

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CanSino Biologics Inc.: lead

Study Sites (1)

Canadian Center for Vaccinology

Halifax, Canada

Location

MeSH Terms

Conditions

Herpes Zoster; Chickenpox; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Scot Halperin, MD

  Canadian Center for Vaccinology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 14, 2023
• Study Start: November 7, 2023
• Primary Completion: November 4, 2024
• Study Completion: November 4, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

CA (1)