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Cancer Vaccine

CRV-101 Vaccine for Shingles

Phase 2
Waitlist Available
Research Sponsored by Curevo Inc
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
Must not have
Chronic administration of immunosuppressants or other immune-modifying drugs
Acute disease and/or fever at the time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 14, and ltfu up to 6 years.
Awards & highlights

Summary

This trial tests a new shingles vaccine called CRV-101 in adults aged 50 and older. The vaccine aims to boost the immune system to prevent shingles. Participants receive two injections and are monitored for safety and effectiveness.

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.
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.
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 below
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I am at least 50 years old and not pregnant.
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I am 50 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not on long-term immune system medications.
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I do not have a fever or any sudden illness now.
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I have been vaccinated against shingles or chickenpox.
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I have an autoimmune disease or a condition that affects my immune system.
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I have no history of severe allergies to vaccines or their components that would stop me from joining the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 14, and ltfu up to 6 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 14, and ltfu up to 6 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Occurrence of adverse events (AEs) of special interest
Occurrence of serious adverse events (SAEs)
Occurrence of solicited local and systemic signs and symptoms
+6 more
Secondary study objectives
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 more
Other study objectives
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 more

Trial 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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Shingles include antiviral medications and vaccines. Antiviral medications like acyclovir, valacyclovir, and famciclovir inhibit viral DNA replication, reducing the severity and duration of the infection. Vaccines, such as the recombinant zoster vaccine (Shingrix), stimulate the immune system to produce a strong response against the varicella-zoster virus, preventing its reactivation. The investigational vaccine CRV-101 likely works similarly by enhancing the immune response to prevent Shingles. These treatments are crucial as they can significantly reduce the incidence of Shingles and its complications, such as postherpetic neuralgia.

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
23,165 Total Patients Enrolled

Media Library

CRV-101 Vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05304351 — Phase 2
Shingles Clinical Trial 2023: CRV-101 Vaccine Highlights & Side Effects. Trial Name: NCT05304351 — Phase 2
Shingles Research Study Groups: Arm F, Arm D, Arm E, Arm C & G, Arm A, Arm B
CRV-101 Vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05304351 — Phase 2
Shingles Patient Testimony for trial: Trial Name: NCT05304351 — Phase 2
~239 spots leftby Oct 2025