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Compensation: Varies

Number of Visits: Unknown

Duration: 4 months

40 Participants Needed

Valacyclovir + Shingrix for Achalasia

Overseen ByMichael McGill, BS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Vanderbilt University Medical Center

Must be taking: Valacyclovir, Shingrix

Disqualifiers: Unstable illness, Neurologic impairment, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that patients with well-controlled conditions like hypertension and diabetes can participate, suggesting that some medications might be allowed.

How does the treatment with Valacyclovir and Shingrix differ from other treatments for achalasia?

This treatment is unique because it combines Valacyclovir, an antiviral medication, with Shingrix, a vaccine originally used to prevent shingles, to address achalasia, a condition with no standard treatment. The combination of an antiviral drug and a vaccine for a non-viral condition like achalasia is novel and may offer a new approach to managing this disorder.¹ ² ³ ⁴ ⁵

What is the purpose of this trial?

Varicella zoster virus (VZV) is the cause of chickenpox and shingles, but it also infects, becomes latent, and reactivates in nerve cells of the bowel to cause a gastrointestinal disorder ("enteric shingles"). The Investigators recently found that a chronic active VZV infection, a form of enteric shingles, is associated with achalasia, a severe disease in which the passage of food from esophagus to stomach is impaired. We now propose to eradicate VZV to determine whether its association with achalasia is causal, to identify the genetic basis behind VZV reactivation in the esophagus, and the relationship of mast cells to enteric shingles and abdominal pain.

Research Team

Michael Vaezi, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

This trial is for men and women aged 18-75 with achalasia, a condition that makes swallowing difficult. Participants must be fluent in English, able to give consent, and undergo specific diagnostic tests. Women of childbearing age should use effective birth control.

Inclusion Criteria

Fluent in English and mentally capable to provide informed consent who present to Vanderbilt University Medical Center Digestive Diseases Center for treatment of achalasia

I have been diagnosed with achalasia and am fit for treatment.

I can undergo specific swallowing tests, a nasal procedure for esophagus testing, and follow a 2-month treatment plan including medication and vaccinations.

Exclusion Criteria

My chronic conditions like high blood pressure or diabetes are well-managed.

I do not have any brain or thinking problems that would stop me from joining a study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients with Achalasia (phenotypes II and III) with VZV DNA in saliva are treated with valacyclovir 3 times per day

4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including response to anti-VZV therapy and incidence of VZV reactivation

1 year

Treatment Details

Interventions

Shingrix
ValACYclovir 1000 MG

Trial Overview The study aims to treat achalasia by targeting the varicella zoster virus (VZV), which may cause it. It involves taking ValACYclovir pills three times daily and receiving two Shingrix injections over two months.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment2 Interventions

Patients with Achalasia (phenotypes II and III) with VZV DNA in saliva. Patients will be treated with valacyclovir 3 times per day. Patients found to benefit from treatment with valacyclovir will be offered Shingrix vaccine (2 - 0.5mL doses)

Shingrix is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Shingrix for:

Prevention of shingles in healthy adults over age 50 and in immunocompromised adults over age 18

Approved in European Union as Shingrix for:

Prevention of herpes zoster (shingles) and postherpetic neuralgia (PHN) in adults 50 years of age and older

Approved in Canada as Shingrix for:

Prevention of herpes zoster (shingles) in adults 50 years of age and older

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Findings from Research

Shingrix is an approved vaccine in Germany for preventing shingles (zoster) and its complications, specifically for adults aged 60 and older.

If patients experience bullous skin lesions after receiving Shingrix, it is important to consider the possibility of zoster disease and report any unexpected side effects to the appropriate medical authorities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Zoster disease after Shingrix vaccination].Kohn, D., Wetzig, T.[2021]

In a study of Medicare beneficiaries aged over 65, Shingrix demonstrated a vaccine effectiveness of 70.1% for those receiving the full 2-dose regimen and 56.9% for those receiving only 1 dose, indicating that completing the 2-dose series is beneficial.

The vaccine remained effective even for individuals over 80 years old and those with autoimmune or immunosuppressive conditions, with a notable 76.0% effectiveness against postherpetic neuralgia, suggesting its broad applicability in older and at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recombinant Zoster Vaccine (Shingrix): Real-World Effectiveness in the First 2 Years Post-Licensure.Izurieta, HS., Wu, X., Forshee, R., et al.[2022]

SHINGRIX, a non-live herpes zoster vaccine, is safe for patients on immunosuppressive therapy, making it a suitable option for those with inflammatory bowel disease who are at higher risk for infections.

A case report of a 74-year-old woman with ulcerative proctosigmoiditis revealed blistering autoimmune skin disorders following SHINGRIX vaccination, suggesting a potential, though previously unreported, adverse effect of the vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blistering autoimmune skin reaction following SHINGRIX vaccination in an ulcerative colitis patient: Case report and literature review.Bell, H., Kamal, N., Wong, U.[2021]