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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male and non-pregnant female participant must be ≥50 years of age inclusive, at the time of signing the informed consent.
Participants must be ≥50 years of age inclusive, at the time of signing the informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 14, and ltfu up to 6 years.
Awards & highlights
Study Summary
This trial will compare the safety and effectiveness of two different vaccines for preventing herpes zoster (also known as shingles) in adults aged 50 and older.
Who is the study for?
Adults aged 50 and older who are healthy, have completed a COVID-19 vaccine series at least 30 days prior to enrollment, and can give informed consent. They must not have had shingles vaccines before, no recent vaccinations or blood donations, no immune system issues or certain medications that affect immunity.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of different doses of CRV-101 vaccine with adjuvants against Shingrix for preventing herpes zoster (shingles). Participants will receive one of several dose combinations to compare responses.See study design
What are the potential side effects?
Potential side effects may include typical vaccine reactions like soreness at the injection site, fever, fatigue, headache. Since it's investigational, there might be unknown risks which will be monitored throughout the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at least 50 years old and not pregnant.
Select...
I am 50 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 14, and ltfu up to 6 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 14, and ltfu up to 6 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Occurrence of adverse events (AEs) of special interest
Occurrence of serious adverse events (SAEs)
Occurrence of solicited local and systemic signs and symptoms
+6 moreSecondary outcome measures
Anti-Varicella Zoster Virus (VZV) neutralizing antibody titer in response to vaccination between Day 0 and Month 3
CMI Vaccine Response rate (≥ 2-fold increase in the frequency of vaccine protein-specific CD4+ T cell expressing at least 2 activation markers) at Month 3
Fold rise of vaccine protein-specific antibody concentrations elicited in response to vaccination for durability post Month 3
+2 moreOther outcome measures
Fold rise of vaccine protein-specific antibody concentrations elicited in response to vaccination post Month 3
Frequency of vaccine protein-specific CD4+ T cells expressing at least 2 activation markers in response to vaccination for durability post Month 3
To assess the correlation between Vaccine protein-specific Ab concentrations, Anti-VZV neutralizing Ab titer, & frequency of vaccine protein-specific CD4+ T cells expressing >=2 activation markers for each vaccine & correlation across vaccines
+2 moreTrial Design
6Treatment groups
Experimental Treatment
Active Control
Group I: Arm FExperimental Treatment1 Intervention
Investigational Vaccine
Group II: Arm EExperimental Treatment1 Intervention
Investigational Vaccine
Group III: Arm DExperimental Treatment1 Intervention
Investigational Vaccine
Group IV: Arm BExperimental Treatment1 Intervention
Investigational Vaccine
Group V: Arm AExperimental Treatment1 Intervention
Investigational Vaccine
Group VI: Arm C & GActive Control1 Intervention
Active comparator
Find a Location
Who is running the clinical trial?
Curevo IncLead Sponsor
1 Previous Clinical Trials
90 Total Patients Enrolled
Mogam Biotechnology Research InstituteUNKNOWN
1 Previous Clinical Trials
90 Total Patients Enrolled
Green Cross CorporationIndustry Sponsor
81 Previous Clinical Trials
23,167 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood test results must be normal or not concerning to the doctor.I am not on long-term immune system medications.I am following the required birth control guidelines.I am not on medication that affects vaccine testing.I understand the study and can sign the consent form.My age is within the required range for the trial.I haven't had any vaccines in the last 30 days or any non-study vaccines while in the study.I am healthy based on recent medical exams and tests.My condition matches the study's required disease characteristics.I am at least 50 years old and not pregnant.I completed my COVID-19 vaccination series at least 30 days before enrolling.Your urine test needs to be normal, or if it's not normal, the doctor will decide if it's a problem.I completed my initial COVID-19 vaccine series over 30 days ago.I do not have a fever or any sudden illness now.I have been vaccinated against shingles or chickenpox.I have not donated blood in the last 60 days.You have a history of alcohol or drug abuse within the past 5 years.I have not received a blood transfusion or any blood products within the last 90 days.I can attend all study visits and can be contacted by phone or in person.I have skin issues that could affect where a vaccine is injected.I am healthy based on recent medical exams and tests.Your blood pressure is too high before receiving the first study injection.I have no chronic illness that could affect vaccine testing.I'm sorry, but I need more information to accurately summarize this criterion. Can you provide more details or context?I have an autoimmune disease or a condition that affects my immune system.I have no history of severe allergies to vaccines or their components that would stop me from joining the study.You have a body mass index (BMI) of 40 or higher.You have had shingles in the past.Your vital signs (such as blood pressure, heart rate, and breathing rate) must be relatively stable and not show any significant abnormalities. If your vital signs are too high or too low, you will not be able to participate. The study staff may check your vital signs multiple times to confirm any abnormal readings.You have had a serious mental health condition in the past.I am 50 years old or older.
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Research Study Groups:
This trial has the following groups:- Group 1: Arm F
- Group 2: Arm D
- Group 3: Arm E
- Group 4: Arm C & G
- Group 5: Arm A
- Group 6: Arm B
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.
Shingles Patient Testimony for trial: Trial Name: NCT05304351 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the CRV-101 Vaccine Antigen High Dose medication allowed by the FDA?
"While there is limited data on the efficacy of CRV-101 Vaccine Antigen High Dose, what information is available points to its safety."
Answered by AI
What are the goals that researchers are hoping to achieve with this trial?
"The primary objective of this study, as measured over a 28 day time frame following each vaccination, is to compare the CRV-101 Vaccine's reactogenicity to that of the standard 2-dose schedule of Shingrix®. Additionally, this trial will secondary objectives which include assessing the durability of vaccine protein-specific antibody concentrations post Month 3, determining the functional humoral immune response to vaccination (sub-study), and measuring the cell-mediated immunity (CMI) immune response to vaccination."
Answered by AI
Are there any open slots left for this experiment?
"Yes, this information is accurate according to the clinicaltrials.gov website. The original posting date was February 2nd, 2022 and there have been updates made as recently as March 22nd, 2022."
Answered by AI
Who else is applying?
What state do they live in?
Nevada
New Mexico
Kansas
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
What site did they apply to?
Curevo Investigational Site
Why did patients apply to this trial?
I’ve never had the singles vaccine because my mom said I never had chicken pox.
PatientReceived 2+ prior treatments
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