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

This study has been completed.
Sponsor:
Collaborators:
University of Malawi College of Medicine
Liverpool School of Tropical Medicine
Wellcome Trust
Information provided by:
Royal Liverpool University Hospital
ClinicalTrials.gov Identifier:
NCT00371878
First received: September 1, 2006
Last updated: August 7, 2008
Last verified: September 2006
History of Changes
  Purpose

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.


Condition Intervention Phase
Pneumonia
Meningitis
Invasive Pneumococcal Disease
HIV
 Biological: 7-valent pneumococcal conjugate vaccine (Prevnar)
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Royal Liverpool University Hospital:

Primary Outcome Measures:
  • Immunoglobulin titres in bronchoalveolar fluid

Secondary Outcome Measures:
  • Immunoglobulin titres in serum
  • Lung lymphocyte phenotype
  • HIV viral load

Estimated Enrollment: 40
Study Start Date: February 2003
Estimated Study Completion Date: October 2003
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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteer adults

Exclusion Criteria:

  • pregnant, recent illness, previous vaccination, asthma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00371878

Locations
Malawi
Wellcome Trust Laboratories and Dept of Medicine, Queen Elizabeth Central Hospital
Blantyre, Malawi, BT3
Sponsors and Collaborators
Royal Liverpool University Hospital
University of Malawi College of Medicine
Liverpool School of Tropical Medicine
Wellcome Trust
Investigators
Study Director: Neil French, PhD FRCP Karonga Prevention Study, London School of Tropical Medicine and Hygience
Principal Investigator: Stephen B Gordon, MA MD FRCP Liverpool School of Tropical Medicine, Liverpool, UK
  More Information

Additional Information:
The Malawi-Liverpool-Wellcome Programme of Clinical Tropical Research has been established for 10 years.  This link exits the ClinicalTrials.gov site
Malawi-Liverpool-Wellcome Major Overseas Programme in Blantyre, Malawi  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00371878     History of Changes
Other Study ID Numbers: BAL0601, ISRCTN54494731, ISRCTN 061230, P99/00/101, P99/00/102
Study First Received: September 1, 2006
Last Updated: August 7, 2008
Health Authority: Malawi: College of Medicine Research and Ethics Committee

Keywords provided by Royal Liverpool University Hospital:
Vaccine
Lung
Bronchoalveolar lavage
Lymphocyte
 Immunoglobulin
HIV
Streptococcus pneumoniae
Conjugate vaccine

Additional relevant MeSH terms:
Meningitis
Pneumonia
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Lung Diseases
Respiratory Tract Diseases
 Respiratory Tract Infections
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on March 10, 2013