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Herpes ZosterPhase 1NCT05991427

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

A Phase 1 study testing Recombinant Zoster Vaccine (Adenovirus Vector) (ChAdOx1-VZV), Zoster Vaccine Recombinant, Adjuvanted (Shingrix) and ChAdOx1-VZV in people with Herpes Zoster, run by CanSino Biologics Inc. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Herpes Zoster
What is being tested?
Recombinant Zoster Vaccine (Adenovirus Vector) (ChAdOx1-VZV), Zoster Vaccine Recombinant, Adjuvanted (Shingrix) and ChAdOx1-VZV
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
65 participants
Where
1 siteCanada
Study dates
7 Nov 2023to 4 Nov 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Canadian Center for Vaccinology

    Halifax

Other trials in Canada

About this study

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

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
Being tested
Recombinant Zoster Vaccine (Adenovirus Vector) (ChAdOx1-VZV), Zoster Vaccine Recombinant, Adjuvanted (Shingrix), ChAdOx1-VZV, Shingrix, IH ChAdOx1-VZV
Keywords
Varicella zoster virus, Safety, Immunogenicity, Intramuscular injection, Inhalation, Vaccine
Medical subject headings
Herpes Zoster, Chickenpox, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

  • Zoster Vaccine Recombinant, Adjuvanted (Shingrix)Biological

    2 doses of Shingrix vaccine on Day 0 and Month 4

  • ChAdOx1-VZVBiological

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

  • ShingrixBiological

    2 doses of Shingrix vaccine on Day 0 and Month 4

  • IH ChAdOx1-VZVBiological

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

  • IH salineBiological

    2 doses of saline on Day 0 and Month 4

Study groups in NCT05991427
Study groupRoleWhat they receive
Experimental vaccine group, low dose, Intramuscular injection(IM)Experimental2 doses of ChAdOX1-VZV vaccine (1 × 10^10 vp) on Day 0 and Month 4
Receives: Biological: Recombinant Zoster Vaccine (Adenovirus Vector) (ChAdOx1-VZV)
Control vaccine group, low dose, IMActive comparator2 doses of Shingrix vaccine (0.5ml) on Day 0 and Month 4
Receives: Biological: Zoster Vaccine Recombinant, Adjuvanted (Shingrix)
Experimental vaccine group, high dose, IMExperimental2 doses of ChAdOX1-VZV vaccine (5 × 10^10 vp) on Day 0 and Month 4
Receives: Biological: ChAdOx1-VZV
Control vaccine group, high dose, IMActive comparator2 doses of Shingrix vaccine (0.5ml) on Day 0 and Month 4
Receives: Biological: Shingrix
Experimental vaccine group, Aerosol, Inhalation(IH)Experimental2 doses of ChAdOX1-VZV vaccine (2 × 10^10 vp) on Day 0 and Month 4
Receives: Biological: IH ChAdOx1-VZV
Saline group, Aerosol, IHPlacebo comparator2 doses of saline (0.2ml) on Day 0 and Month 4
Receives: Biological: IH saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of local and systemic reactogenicity within 7 days after each vaccination

    Measured: Within 7 days after each vaccination

  2. Incidence of Serious Adverse Event (SAE) and Adverse Event of Special Interest (AESI) from the 1st dose to the end of study.

    Measured: From the 1st dose to the end of study

Secondary outcomes (5)

  1. The unsolicited adverse events for 28 days after each vaccination

    Measured: 28 days after each vaccination

  2. 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.

    Measured: Day 7 post each vaccination

  3. The Geometric mean titer (GMT) of gE-specific antibody using Enzyme-linked Immunosorbent Assay (ELISA) over the time course.

    Measured: Through study completion, an average of 8 months

  4. The GMT of gE-specific antibody 28 days after the 1st and 2nd dose vaccination across each vaccination group.

    Measured: 28 days after the 1st and 2nd dose vaccination

  5. The gE-specific IFN-γ by EliSpot over the time course of the study

    Measured: Through study completion, an average of 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start7 Nov 2023
  3. Primary completion4 Nov 2024
  4. Study completion4 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05991427
Sponsor's protocol ID
CTP-CVE-001
Status last verified
Dec 2024
First submitted
28 Jul 2023
Last updated
4 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Recombinant Zoster Vaccine (Adenovirus Vector) (ChAdOx1-VZV), Zoster Vaccine Recombinant, Adjuvanted (Shingrix) and ChAdOx1-VZV in people with Herpes Zoster, run by CanSino Biologics Inc. at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of local and systemic reactogenicity within 7 days after each vaccination (time frame: Within 7 days after each vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05991427.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.

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