NCT00371878

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2003

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2006

Completed
Last Updated

August 8, 2008

Status Verified

September 1, 2006

First QC Date

September 1, 2006

Last Update Submit

August 7, 2008

Conditions

PneumoniaMeningitisInvasive Pneumococcal DiseaseHIV

Keywords

VaccineLungBronchoalveolar lavageLymphocyteImmunoglobulinHIVStreptococcus pneumoniaeConjugate vaccine

Outcome Measures

Primary Outcomes (1)

  • Immunoglobulin titres in bronchoalveolar fluid

Secondary Outcomes (3)

  • Immunoglobulin titres in serum

  • Lung lymphocyte phenotype

  • HIV viral load

Interventions

7-valent pneumococcal conjugate vaccine (Prevnar)BIOLOGICAL

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • healthy volunteer adults

You may not qualify if:

  • pregnant, recent illness, previous vaccination, asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Blantyre, BT3, Malawi

Location

MeSH Terms

Conditions

PneumoniaMeningitis

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesNeuroinflammatory DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Pneumococcal VaccinesStreptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex MixturesVaccines, Combined

Study Officials

  • Neil French, PhD FRCP

    Karonga Prevention Study, London School of Tropical Medicine and Hygience

    STUDY DIRECTOR

  • Stephen B Gordon, MA MD FRCP

    Liverpool School of Tropical Medicine, Liverpool, UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 1, 2006

First Posted

September 4, 2006

Study Start

February 1, 2003

Study Completion

October 1, 2003

Last Updated

August 8, 2008

Record last verified: 2006-09

Locations

MA(1)