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NCT00851786 · ClinicalTrials.gov registry record · Phase 2

Live Zoster Vaccine in HIV-Infected Adults on Antiretroviral Therapy

A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 2
Development phase
395
Enrollment target

NCT00851786: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00851786 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 395 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (197% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00851786, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
395 participants
Enrollment target

Study Summary

Herpes zoster, or shingles, is the result of a viral infection that causes a painful skin rash, usually in older people or people with suppressed immune systems like those infected with HIV. The ZOSTAVAX vaccine has been shown to reduce the number of infections and symptoms of herpes zoster infection in people over the age of 60. The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of two doses of ZOSTAVAX in HIV-1-infected adults with conserved immune function (Cd4+ T cell counts \>=200 cells/uL) virologically suppressed on potent combination antiretroviral therapy (ART).

Primary Outcome

Although the study was designed as a randomized trial, it was not powered to detect safety related differences between treatment arms. The safety of ZOSTAVAX was determined by comparing the number of subjects from the active arm who experienced safety endpoint to the number from a pre-specified decision rule, which was calculated based on a similar population and calibrated using the number of safety endpoints observed from the placebo arm. The pre-specified decision rule is that ZOSTAVAX would

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL ZOSTAVAX

Trial Details

FieldValue
Enrollment Target 395 participants
Start Date 2009-04-29
Est. Completion 2012-01-03
Phase Phase 2

What the finished NCT00851786 record still lists

NCT00851786 is an interventional study that assigns participants to a tested intervention. The registered 395 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (197% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00851786 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00851786 about?

NCT00851786 is a clinical study titled "Live Zoster Vaccine in HIV-Infected Adults on Antiretroviral Therapy". Herpes zoster, or shingles, is the result of a viral infection that causes a painful skin rash, usually in older people or people with suppressed immune systems like those infected with HIV. The ZOSTAVAX vaccine has been shown to reduce the number of infections and symptoms of herpes zoster infectio...

What is the current status of trial NCT00851786?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 395 participants. The study started on 2009-04-29. Estimated completion is 2012-01-03.

What interventions are being tested in trial NCT00851786?

The interventions under investigation include: Placebo (BIOLOGICAL), ZOSTAVAX (BIOLOGICAL).

Who is sponsoring clinical trial NCT00851786?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00851786's enrollment target sits among peer trials

395 103rd of 2000 higher than 1,898 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT00851786, the US trial registry maintained by the National Library of Medicine. NCT00851786 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.