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

This study has been completed.
University of Malawi College of Medicine
Liverpool School of Tropical Medicine
Wellcome Trust
Information provided by:
Royal Liverpool University Hospital Identifier:
First received: September 1, 2006
Last updated: August 7, 2008
Last verified: September 2006
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
Invasive Pneumococcal Disease
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:

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.

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

Inclusion Criteria:

  • healthy volunteer adults

Exclusion Criteria:

  • pregnant, recent illness, previous vaccination, asthma
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Please refer to this study by its identifier: NCT00371878

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
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:
No publications provided 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:
Bronchoalveolar lavage
Streptococcus pneumoniae
Conjugate vaccine

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs processed this record on December 01, 2015