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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

September 1, 2006
August 7, 2008
February 2003
Not Provided
Immunoglobulin titres in bronchoalveolar fluid
Same as current
Complete list of historical versions of study NCT00371878 on ClinicalTrials.gov Archive Site
  • Immunoglobulin titres in serum
  • Lung lymphocyte phenotype
  • HIV viral load
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Pneumonia
  • Meningitis
  • Invasive Pneumococcal Disease
  • HIV
Biological: 7-valent pneumococcal conjugate vaccine (Prevnar)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
October 2003
Not Provided

Inclusion Criteria:

  • healthy volunteer adults

Exclusion Criteria:

  • pregnant, recent illness, previous vaccination, asthma
Both
17 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Malawi
 
NCT00371878
BAL0601, ISRCTN54494731, ISRCTN 061230, P99/00/101, P99/00/102
Not Provided
Not Provided
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
Royal Liverpool University Hospital
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP