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OpenTrials
Completed

NCT Number: NCT00371878

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

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.

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Key information

Conditions

Pneumonia HIV Infections Invasive Pneumococcal Disease Lung Diseases Meningitis Nervous System Diseases Neuroinflammatory Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wellcome Trust Laboratories and Dept of Medicine, Queen Elizabeth Central Hospital

Blantyre, BT3, Malawi

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy volunteer adults

Exclusion criteria

  • pregnant, recent illness, previous vaccination, asthma

Treatment and study plan

7-valent pneumococcal conjugate vaccine (Prevnar)

Biological

Primary outcomes

  1. Immunoglobulin titres in bronchoalveolar fluid

Secondary outcomes

  1. Immunoglobulin titres in serum

  2. Lung lymphocyte phenotype

  3. HIV viral load

Sponsors and collaborators

Lead sponsor

Royal Liverpool University Hospital

Other Gov

Collaborators

  • Kamuzu University of Health Sciences
  • Liverpool School of Tropical Medicine
  • Wellcome Trust

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2003
First posted
Sep 4, 2006
Registry last updated
Aug 8, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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