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

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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00371878
Enrollment
40
Registered
2006-09-04
Start date
2003-02-28
Completion date
2003-10-31
Last updated
2008-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Invasive Pneumococcal Disease, Meningitis, Pneumonia

Keywords

Vaccine, Lung, Bronchoalveolar lavage, Lymphocyte, Immunoglobulin, HIV, Streptococcus pneumoniae, Conjugate vaccine

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-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.

Interventions

BIOLOGICAL7-valent pneumococcal conjugate vaccine (Prevnar)

Sponsors

Kamuzu University of Health Sciences
CollaboratorOTHER
Liverpool School of Tropical Medicine
CollaboratorOTHER
Wellcome Trust
CollaboratorOTHER
Royal Liverpool University Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* healthy volunteer adults

Exclusion criteria

* pregnant, recent illness, previous vaccination, asthma

Design outcomes

Primary

MeasureTime frame
Immunoglobulin titres in bronchoalveolar fluid

Secondary

MeasureTime frame
Immunoglobulin titres in serum
Lung lymphocyte phenotype
HIV viral load

Countries

Malawi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026