Ignite Creation Date:
2024-05-05 @ 9:17 PM
Last Modification Date:
2024-10-26 @ 10:02 AM
Study NCT ID:
NCT00851786
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
2009-02-25
Brief Title:
Live Zoster Vaccine in HIV-Infected Adults on Antiretroviral Therapy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Randomized Double-Blind Placebo-Controlled Clinical Trial to Evaluate the Safety Tolerability and Immunogenicity of ZOSTAVAX Zoster Vaccine Live in Human Immunodeficiency Virus HIV-1-Infected Adults on Potent Combination ART With Conserved Immune Function
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 cellsuL virologically suppressed on potent combination antiretroviral therapy ART
Detailed Description:
The varicella-zoster virus VZV which causes herpes zoster HZ or shingles is associated with a painful skin rash and post-herpetic neuralgia PHN The incidence and severity of HZ and PHN increase as immune function decreases as in elderly or HIV-infected people The live VZV vaccine ZOSTAVAX has been shown to reduce the incidence and severity of HZ and PHN in people over the age of 60 The main purpose of this study is to determine whether a two-dose regimen of ZOSTAVAX is safe and well-tolerated in HIV-infected individuals with conserved immune function
This study has two stages and two arms It may last up to 24 weeks per subject In Stage 1 48 participants with CD4 cell counts of 200 or more cellsuL will be enrolled 24 participants with a CD4 count between 200 and 349 cellsuL and 24 participants with a CD4 count equaling 350 or more cellsuL These participants will be randomized 31 to receive two doses of ZOSTAVAX or placebo at least six weeks apart If certain safety criteria are met for Stage 1 enrollment will be opened to Stage 2 Stage 2 will enroll approximately 352 subjects with CD4 T cell counts 200 cellsuL In Stage 2 participants will be stratified using the same parameters as Stage 1 and will then be randomized 31 to receive either two doses of vaccine or placebo according to the same schedule Participants will be followed for at least 42 days after each vaccination Temperatures will be collected daily for 42 days following each vaccination Telephone contact will also be made 2 to 3 days after each vaccination and at 24 weeks following the initial vaccination to obtain information regarding vaccination-related symptoms
All participants will have between 6 and 8 study visits At the screening visit documentation of HIV status is required and blood and urine collection a physical exam medical history and clinical assessment will occur At each visit a targeted physical exam will occur At some visits blood and urine collection and a clinical assessment will occur Antiretroviral medications are not provided by this study
This study has two stages and two arms It may last up to 24 weeks per subject In Stage 1 48 participants with CD4 cell counts of 200 or more cellsuL will be enrolled 24 participants with a CD4 count between 200 and 349 cellsuL and 24 participants with a CD4 count equaling 350 or more cellsuL These participants will be randomized 31 to receive two doses of ZOSTAVAX or placebo at least six weeks apart If certain safety criteria are met for Stage 1 enrollment will be opened to Stage 2 Stage 2 will enroll approximately 352 subjects with CD4 T cell counts 200 cellsuL In Stage 2 participants will be stratified using the same parameters as Stage 1 and will then be randomized 31 to receive either two doses of vaccine or placebo according to the same schedule Participants will be followed for at least 42 days after each vaccination Temperatures will be collected daily for 42 days following each vaccination Telephone contact will also be made 2 to 3 days after each vaccination and at 24 weeks following the initial vaccination to obtain information regarding vaccination-related symptoms
All participants will have between 6 and 8 study visits At the screening visit documentation of HIV status is required and blood and urine collection a physical exam medical history and clinical assessment will occur At each visit a targeted physical exam will occur At some visits blood and urine collection and a clinical assessment will occur Antiretroviral medications are not provided by this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ACTG A5247 | Registry Identifier | DAIDS ES Registry ID | None |
| 10519 | REGISTRY | None | None |