Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing Shingrix for Herpes Zoster

Background: Shingles is a painful, blistering rash caused by the same virus that causes chickenpox. Shingrix is a vaccine approved to prevent shingles in healthy adults over age 50 and in immunocompromised adults over age 18.

Official registry: https://clinicaltrials.gov/study/NCT05580458 · National Institute of Allergy and Infectious Diseases (NIAID) · enrollment listed as 225

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Shingrix. The registry lists allocation as na. Background: Shingles is a painful, blistering rash caused by the same virus that causes chickenpox.

They plan to enroll about 225 people at Bethesda. Taking part typically means an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

Phase 1/2 Open-label Trial of Safety and Zoster Immunogenicity Evaluation for People With HIV With CD4 Counts Under and Above 300 and Healthy Volunteers Following Shingrix Vaccination (ZEUS)

Interventions: Shingrix

Primary outcome (registry wording): Fold change of anti-gE antibody concentrations evaluated regularly through the end of study (months 3 and 12) by CD4 count (< 300 and >= 300)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • General who can join:
  • Individuals must meet all of the following criteria to be eligible for study participation:
  • Participants of childbearing potential must agree to use at least 1 acceptable method of contraception when engaging in sexual activities that can result in pregnancy, beginning at screening through month 3. Acceptable methods of contraception include the following:
  • Hormonal contraception
  • Male or female condom
  • Diaphragm or cervical cap with a spermicide
  • Intrauterine device

Public study contact (from the registry)

Maura M Manion, M.D.

(301) 312-2103

maura.manion@nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT05580458 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05580458?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05580458?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary