Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00371878
Status:
COMPLETED
Last Update Posted:
2008-08-08
First Post:
2006-09-01
Brief Title:
Immunogenicity of 7-Valent Pneumococcal Conjugate Vaccine in Lung Fluid of Adults With and Without HIV Infection
Sponsor:
Royal Liverpool University Hospital
Organization:
Royal Liverpool University Hospital
Study Overview
Official Title:
Open Label Study of Lung and Serum Immunoglobulin Responses to 7-Valent Pneumococcal Conjugate Vaccine in HIV Infected and Non-HIV Infected Malawian Adults
Status:
COMPLETED
Status Verified Date:
2006-09
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:
Lung immune responses are regulated independently of systemic responses Injected vaccines may induce optimal responses in blood but not at mucosal surfaces We compared the responses in serum and lung fluid to injected pneumococcal conjugate vaccine
Detailed Description:
We tested the hypothesis that conjugate vaccine offered less protection against pneumonia due to a reduced mucosal response compared to serum We further hypothesized that this response would be further compromised with HIV co-infection32 due to lack of local CD4 lymphocyte support and an altered alveolar milieu We measured pneumococcal capsular specific immunoglobulin responses to 7-valent conjugate vaccine in both lung fluid and serum from healthy HIV infected and uninfected volunteers together with flow cytometric assessment of the relative numbers and phenotypes of BAL T lymphocyte B lymphocyte and macrophages
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 |
|---|---|---|---|
| P9900102 | None | None | None |
| ISRCTN54494731 | None | None | None |
| ISRCTN 061230 | None | None | None |
| P9900101 | None | None | None |