Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00137605
Status:
COMPLETED
Last Update Posted:
2014-02-13
First Post:
2005-08-26
Brief Title:
Early Versus Delayed Pneumococcal Vaccination in HIV
Sponsor:
CIHR Canadian HIV Trials Network
Organization:
CIHR Canadian HIV Trials Network
Study Overview
Official Title:
A Pilot Study Assessing the Efficacy of Pneumococcal Vaccine in HIV Patients Delayed Versus Immediate Immunization
Status:
COMPLETED
Status Verified Date:
2014-02
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:
The purpose of this study is to determine whether people who are HIV-positive respond better to a vaccine for pneumonia-related disease when they are immunized immediately or when immunization is delayed until the immune system has improved to a certain level The study will also compare the effectiveness of polysaccharide and heptavalent vaccines
Detailed Description:
A multicentre randomized controlled trial using a two factorial design Eighty patients will be randomly assigned to receive either Pneumovax or Pneumo23 according to standard use at site or heptavalent pneumococcal conjugate vaccine Prevnar prior to reconstitution of the immune system or will have immunization delayed until their CD4 count is greater than 200 cellsmm3 after the introduction of antiretroviral therapy Randomization will be stratified by study centre Variable block sizes will be used to try to prevent study personnel from guessing the next allocation Random allocation lists will be generated by computer
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 |
|---|---|---|---|
| File 9427-C1574-34C | None | None | None |
| Control 078760 | None | None | None |