What side effects are associated with this type of intervention?

Common treatments for shingles include antiviral medications like valaciclovir and acyclovir, and vaccines such as Shingrix. Valaciclovir and acyclovir are generally well-tolerated but can cause side effects like nausea, headache, and abdominal pain. Shingrix, a vaccine for herpes zoster, can cause injection site reactions (pain, redness, and swelling), muscle pain, fatigue, headache, shivering, fever, and gastrointestinal symptoms. The investigational vaccine CRV-101 is being studied for its safety and immunogenicity, but specific side effects are not detailed in the provided context.

What prior FDA approvals exist?

The FDA has approved Shingrix, a recombinant zoster vaccine, for the prevention of herpes zoster (shingles) in adults aged 50 years and older. Shingrix is known for its high efficacy in preventing shingles and its complications. Additionally, antiviral medications such as acyclovir, valacyclovir, and famciclovir are FDA-approved for the treatment of acute herpes zoster infections, helping to reduce the severity and duration of the illness. These treatments are relevant to the investigational vaccine CRV-101, which is being studied for its safety and immunogenicity in preventing shingles.

What other types of research exist?

A promising, novel alternative to CRV-101 for shingles patients in 2024 is Shingrix, an adjuvanted herpes zoster subunit vaccine known for its higher efficacy and suitability for immunocompromised individuals.

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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

No Placebo-Only Group

All Individual Drugs Already Approved

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 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.

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

Awards & Highlights

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.

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

0 / 7Eligibility criteria met

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.