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Live Zoster Vaccine in HIV-Infected Adults on Antiretroviral Therapy

NCT00851786 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 395

Last updated 2021-11-04

Study results available
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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).

Conditions

  • Herpes Zoster
  • HIV Infections

Interventions

BIOLOGICAL

ZOSTAVAX

Subcutaneous injection of 0.65 mL of ZOSTAVAX at Day 0 and Week 6

BIOLOGICAL

Placebo

Subcutaneous injection of 0.65 mL of placebo at Day 0 and Week 6

Sponsors & Collaborators

  • Adult AIDS Clinical Trials Group

    collaborator NETWORK

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Constance A. Benson, MD · University of California, San Diego

  • Jeffrey L. Lennox, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-29
Primary Completion
2011-09-22
Completion
2012-01-03

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00851786 on ClinicalTrials.gov