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

Open Label Study of Lung and Serum Immunoglobulin Responses to 7-Valent Pneumococcal Conjugate Vaccine in HIV Infected and Non-HIV Infected Malawian Adults

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia; HIV; Meningitis; Invasive Pneumococcal Disease
• Intervention / Treatment: Biological: 7-valent pneumococcal conjugate vaccine (Prevnar)

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: Interventional
• Enrollment: 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Malawi
  • Blantyre, Malawi, BT3
    • Wellcome Trust Laboratories and Dept of Medicine, Queen Elizabeth Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy volunteer adults

Exclusion Criteria:

• pregnant, recent illness, previous vaccination, asthma

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Immunoglobulin titres in bronchoalveolar fluid

Secondary Outcome Measures

Outcome Measure
HIV viral load
Immunoglobulin titres in serum
Lung lymphocyte phenotype

Collaborators and Investigators

• Sponsor: Royal Liverpool University Hospital
• Collaborators: Wellcome Trust; Liverpool School of Tropical Medicine; Kamuzu University of Health Sciences
• 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

Study record dates

Study Major Dates

• Study Start: February 1, 2003
• Study Completion: October 1, 2003

Study Registration Dates

• First Submitted: September 1, 2006
• First Submitted That Met QC Criteria: September 1, 2006
• First Posted (Estimate): September 4, 2006

Study Record Updates

• Last Update Posted (Estimate): August 8, 2008
• Last Update Submitted That Met QC Criteria: August 7, 2008
• Last Verified: September 1, 2006

More Information

Terms related to this study

• Keywords: HIV; Vaccine; Lung; Conjugate vaccine; Immunoglobulin; Bronchoalveolar lavage; Streptococcus pneumoniae; Lymphocyte
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumococcal Infections; Pneumonia; Meningitis; Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: BAL0601; ISRCTN54494731; ISRCTN 061230; P99/00/101; P99/00/102