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

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ClinicalTrials.gov Identifier: NCT00371878
Recruitment Status : Completed
First Posted : September 4, 2006
Last Update Posted : August 8, 2008
Sponsor:
Collaborators:
University of Malawi College of Medicine
Liverpool School of Tropical Medicine
Wellcome Trust
Information provided by:
Royal Liverpool University Hospital

Tracking Information
First Submitted Date  ICMJE September 1, 2006
First Posted Date  ICMJE September 4, 2006
Last Update Posted Date August 8, 2008
Study Start Date  ICMJE February 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2006)
Immunoglobulin titres in bronchoalveolar fluid
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00371878 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2006)
  • Immunoglobulin titres in serum
  • Lung lymphocyte phenotype
  • HIV viral load
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunogenicity of 7-Valent Pneumococcal Conjugate Vaccine in Lung Fluid of Adults With and Without HIV Infection
Official Title  ICMJE Open Label Study of Lung and Serum Immunoglobulin Responses to 7-Valent Pneumococcal Conjugate Vaccine in HIV Infected and Non-HIV Infected Malawian Adults
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Pneumonia
  • Meningitis
  • Invasive Pneumococcal Disease
  • HIV
Intervention  ICMJE Biological: 7-valent pneumococcal conjugate vaccine (Prevnar)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 1, 2006)
40
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE October 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy volunteer adults

Exclusion Criteria:

  • pregnant, recent illness, previous vaccination, asthma
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malawi
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00371878
Other Study ID Numbers  ICMJE BAL0601
ISRCTN54494731
ISRCTN 061230
P99/00/101
P99/00/102
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Royal Liverpool University Hospital
Collaborators  ICMJE
  • University of Malawi College of Medicine
  • Liverpool School of Tropical Medicine
  • Wellcome Trust
Investigators  ICMJE
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
PRS Account Royal Liverpool University Hospital
Verification Date September 2006

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