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Virus Therapy
ChAdOx1-VZV Vaccine for Shingles
Phase 1
Recruiting
Led By Scot Halperin, MD
Research Sponsored by CanSino Biologics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 8 months
Awards & highlights
Study Summary
This trial tests how safe and effective a new drug is by having participants take 2 doses over 4 months. Blood samples will be taken to evaluate results.
Who is the study for?
Healthy adults aged 50-65 who can follow the study procedures and are in stable health may join. They must not be current smokers, have a history of severe allergies to vaccines, or be immunocompromised. Women must test negative for pregnancy and use contraception, as should men.Check my eligibility
What is being tested?
The trial is testing a new shingles vaccine called ChAdOx1-VZV against an existing one named Shingrix. Participants will receive two doses four months apart with blood tests to check their immune response. Some will get the vaccine through inhalation.See study design
What are the potential side effects?
Possible side effects include typical reactions at the injection site like pain and swelling, general symptoms such as fever or fatigue, allergic responses, and potentially other mild to moderate effects that are common with vaccinations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 8 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 8 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Serious Adverse Event (SAE) and Adverse Event of Special Interest (AESI) from the 1st dose to the end of study.
Incidence of local and systemic reactogenicity within 7 days after each vaccination
Secondary outcome measures
The GMT of gE-specific antibody 28 days after the 1st and 2nd dose vaccination across each vaccination group.
The Geometric mean titer (GMT) of gE-specific antibody using Enzyme-linked Immunosorbent Assay (ELISA) over the time course.
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.
+2 moreTrial Design
6Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Experimental vaccine group, low dose, Intramuscular injection(IM)Experimental Treatment1 Intervention
2 doses of ChAdOX1-VZV vaccine (1 × 10^10 vp) on Day 0 and Month 4
Group II: Experimental vaccine group, high dose, IMExperimental Treatment1 Intervention
2 doses of ChAdOX1-VZV vaccine (5 × 10^10 vp) on Day 0 and Month 4
Group III: Experimental vaccine group, Aerosol, Inhalation(IH)Experimental Treatment1 Intervention
2 doses of ChAdOX1-VZV vaccine (2 × 10^10 vp) on Day 0 and Month 4
Group IV: Control vaccine group, low dose, IMActive Control1 Intervention
2 doses of Shingrix vaccine (0.5ml) on Day 0 and Month 4
Group V: Control vaccine group, high dose, IMActive Control1 Intervention
2 doses of Shingrix vaccine (0.5ml) on Day 0 and Month 4
Group VI: Saline group, Aerosol, IHPlacebo Group1 Intervention
2 doses of saline (0.2ml) on Day 0 and Month 4
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
CanSino Biologics Inc.Lead Sponsor
32 Previous Clinical Trials
64,306 Total Patients Enrolled
Scot Halperin, MDPrincipal InvestigatorCanadian Center for Vaccinology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or had lung problems like asthma or COPD.I am in stable health or have a mild condition that hasn't needed new treatment for 6 months.I have a weakened immune system due to a stem cell transplant, AIDS, or symptomatic HIV.I have not received blood products or immunoglobulin in the last 90 days and do not expect to need them during the study.I have not received an adenovirus vector vaccine in the last 6 months.I haven't used any experimental drugs or vaccines in the last 30 days and don't plan to during the study.I have been vaccinated against shingles.I do not have serious heart, liver, kidney diseases, or complicated diabetes.I haven't had vaccines within a month before or plan to within a month after the trial vaccine.I have had shingles within the last 5 years.I haven't taken high-dose immune system drugs in the last 6 months.I agree to use contraception during and for 30 days after the vaccine trial.I am currently undergoing or will undergo chemotherapy, and I was diagnosed with or treated for cancer in the last 5 years.I am between 50 and 65 years old.I have a history of serious blood clotting problems.I am not pregnant, have tested negative for pregnancy, and will use birth control during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental vaccine group, low dose, Intramuscular injection(IM)
- Group 2: Control vaccine group, low dose, IM
- Group 3: Experimental vaccine group, high dose, IM
- Group 4: Control vaccine group, high dose, IM
- Group 5: Experimental vaccine group, Aerosol, Inhalation(IH)
- Group 6: Saline group, Aerosol, IH
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 0 awards, including:Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What criteria must be fulfilled to qualify for enrollment in this investigation?
"Eligibility for this trial necessitates the applicant having a diagnosis of shingles and being no younger than 50, nor older than 65. Sixty-five individuals are required to complete the study."
Answered by AI
Does this research endeavor include any individuals over the age of fifty?
"The enrollment requirements of this trial stipulate that the minimum age for participants to qualify is 50, while those over 65 will not be considered."
Answered by AI
What are the potential risks associated with receiving an intramuscular injection of a low-dose experimental vaccine?
"Our team at Power assigned Experimental vaccine group, low dose, Intramuscular injection(IM) a score of 1 due to the limited clinical evidence that supports its safety and efficacy. This is consistent with Phase 1 trial standards."
Answered by AI
Are there any opportunities for people to enroll in this experiment at present?
"While this trial, which was initially available on September 1st 2023, is not presently seeking new participants; luckily 38 other studies are open to recruitment."
Answered by AI
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