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NCT05580458 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
A Phase 1 study of Herpes Zoster, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 225
- Enrollment target
- 1
- Study location
NCT05580458: Recruiting Phase 1 study of Herpes Zoster, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05580458 is a Phase 1 study of Herpes Zoster that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 225 participants, below the 2,159-participant average among 16 other Herpes Zoster trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05580458, a Phase 1 study of Herpes Zoster, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 225 participants
- Enrollment target
- 1
- Study location
Study Summary
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. Researchers want to learn more about how people with HIV respond to Shingrix. Objective: To learn how Shingrix affects the immune response in people with HIV. Eligibility: People aged 18 years and older with HIV. Healthy people aged 50 years or older are also needed. Design: Participants will have at least 4 clinic visits in 1 year. Participants will be screened. They will have a physical exam with blood and urine tests. At their first visit, participants will receive Shingrix as a shot in the upper arm. They will have a rectal swab; a cotton swab will be inserted into the rectum and rotated gently to collect bacteria. Participants will receive a second shot of Shingrix 2 months after the first one. They will visit the clinic again 3 and 12 months after the first shot. Participants will receive a 28-day memory tool. They will write down their symptoms between clinic visits. They will have up to 4 phone calls to talk about side effects of the shot. Participants may undergo apheresis: They will lie still while blood is drawn from a needle in one arm. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be given back through a second needle in their other arm.
Primary Outcome
Assess vaccine immunogenicity after administration of a full Shingrix series schedule in PWH based upon CD4 count \< 300 and \>= 300.
Conditions Studied
Interventions
- BIOLOGICAL Shingrix
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2023-03-13 |
| Est. Completion | 2027-10-01 |
| Phase | Phase 1 |
What NCT05580458 shows while recruiting
NCT05580458 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, below the 2,159-participant average among 16 other Herpes Zoster trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Herpes Zoster appearing as the primary indexed condition, and to 1 intervention - of which Shingrix is the first listed.
NCT05580458 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05580458 about?
NCT05580458 is a clinical study titled "Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population". 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. Researchers want to learn more about how people with HIV respond to Shing...
What is the current status of trial NCT05580458?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 225 participants. The study started on 2023-03-13. Estimated completion is 2027-10-01.
What conditions does trial NCT05580458 study?
This clinical trial studies the following conditions: Herpes Zoster.
What interventions are being tested in trial NCT05580458?
The interventions under investigation include: Shingrix (BIOLOGICAL).
Who is sponsoring clinical trial NCT05580458?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05580458 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Herpes Zoster
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05580458's enrollment target sits among peer trials
225 10th of 16 higher than 7 of 16 other Herpes Zoster trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Herpes Zoster trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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