Immunogenicity of 7-Valent Pneumococcal Conjugate Vaccine in Lung Fluid of Adults With and Without HIV Infection

HIV Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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-infection[32] 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV
• Invasive Pneumococcal Disease
• Meningitis
• Pneumonia

• NCT number: NCT00371878
• Study type: Interventional
• Source: Royal Liverpool University Hospital
• Status: Completed
• Phase: Phase 4
• Start date: February 2003
• Completion date: October 2003