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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:
ClinicalTrials.gov Identifier:
NCT00371878
First Posted: September 4, 2006
Last Update Posted: August 8, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Malawi College of Medicine
Liverpool School of Tropical Medicine
Wellcome Trust
Information provided by:
Royal Liverpool University Hospital
  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
Intervention Model: Single Group Assignment
Masking: None (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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteer adults

Exclusion Criteria:

  • pregnant, recent illness, previous vaccination, asthma
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00371878     History of Changes
Other Study ID Numbers: BAL0601
ISRCTN54494731
ISRCTN 061230
P99/00/101
P99/00/102
First Submitted: September 1, 2006
First Posted: September 4, 2006
Last Update Posted: August 8, 2008
Last Verified: September 2006

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

Additional relevant MeSH terms:
Pneumonia
Meningitis
Pneumococcal Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Central Nervous System Diseases
Nervous System Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunoglobulins
Antibodies
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs