Immunogenicity of 7-Valent Pneumococcal Conjugate Vaccine in Lung Fluid of Adults With and Without HIV Infection
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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 |
- Immunoglobulin titres in bronchoalveolar fluid
- Immunoglobulin titres in serum
- Lung lymphocyte phenotype
- HIV viral load
Estimated Enrollment: | 40 |
Study Start Date: | February 2003 |
Estimated Study Completion Date: | October 2003 |
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
Malawi | |
Wellcome Trust Laboratories and Dept of Medicine, Queen Elizabeth Central Hospital | |
Blantyre, Malawi, BT3 |
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 |
Additional Information:
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