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

NCT ID: NCT00371878

Last Updated: 2008-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2003-10-31

Brief Summary

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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

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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.

Conditions

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Pneumonia Meningitis Invasive Pneumococcal Disease HIV

Keywords

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Vaccine Lung Bronchoalveolar lavage Lymphocyte Immunoglobulin HIV Streptococcus pneumoniae Conjugate vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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7-valent pneumococcal conjugate vaccine (Prevnar)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* healthy volunteer adults

Exclusion Criteria

* pregnant, recent illness, previous vaccination, asthma
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kamuzu University of Health Sciences

OTHER

Sponsor Role collaborator

Liverpool School of Tropical Medicine

OTHER

Sponsor Role collaborator

Wellcome Trust

OTHER

Sponsor Role collaborator

Royal Liverpool University Hospital

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Neil French, PhD FRCP

Role: STUDY_DIRECTOR

Karonga Prevention Study, London School of Tropical Medicine and Hygience

Stephen B Gordon, MA MD FRCP

Role: PRINCIPAL_INVESTIGATOR

Liverpool School of Tropical Medicine, Liverpool, UK

Locations

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Wellcome Trust Laboratories and Dept of Medicine, Queen Elizabeth Central Hospital

Blantyre, , Malawi

Site Status

Countries

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Malawi

Other Identifiers

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ISRCTN54494731

Identifier Type: -

Identifier Source: secondary_id

ISRCTN 061230

Identifier Type: -

Identifier Source: secondary_id

P99/00/101

Identifier Type: -

Identifier Source: secondary_id

P99/00/102

Identifier Type: -

Identifier Source: secondary_id

BAL0601

Identifier Type: -

Identifier Source: org_study_id