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

HIV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00371878
• Other study ID #: BAL0601
• Secondary ID: ISRCTN54494731IS
• Status: Completed
• Phase: Phase 4
• First received: September 1, 2006
• Last updated: August 7, 2008
• Start date: February 2003
• Est. completion date: October 2003

Study information

• Verified date: September 2006
• Source: Royal Liverpool University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malawi: College of Medicine Research and Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• healthy volunteer adults

Exclusion Criteria:

• pregnant, recent illness, previous vaccination, asthma

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV
• Invasive Pneumococcal Disease
• Meningitis
• Pneumonia

Intervention

Biological:
• 7-valent pneumococcal conjugate vaccine (Prevnar)

Locations

Country	Name	City	State
Malawi	Wellcome Trust Laboratories and Dept of Medicine, Queen Elizabeth Central Hospital	Blantyre

Sponsors (4)

Lead Sponsor	Collaborator
Royal Liverpool University Hospital	Liverpool School of Tropical Medicine, University of Malawi College of Medicine, Wellcome Trust

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunoglobulin titres in bronchoalveolar fluid
Secondary	Immunoglobulin titres in serum
Secondary	Lung lymphocyte phenotype
Secondary	HIV viral load

External Links

•   Malawi-Liverpool-Wellcome Major Overseas Programme in Blantyre, Malawi