Immune Responses to BCG Vaccination in Malawi and the UK | NCT00241657

Studies
Immune Responses to BCG Vaccination in Malawi and the UK

NCT00241657

Sponsor

London School of Hygiene and Tropical Medicine

Status

Completed

Last Update Posted

Dec 15, 2005Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Immunity, Cellular
Hypersensitivity, Delayed Type

Interventions

Countries

Malawi
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2002

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 17, 2005

First Submission Date that Met QC Criteria

Oct 18, 2005

First Posted Date

Oct 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2005

Last Update Posted Date

Dec 15, 2005Estimated

Description Module

Brief Summary

BCG vaccination has been found to provide greater protection against TB in the UK than in Malawi. This study compares immune responses in BCG-vaccinated and unvaccinated teenagers and young adults in Malawi and in the UK.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
BCG	Biological

Measure	Description	Time Frame
scar size

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BCG unvaccinated
HIV negative
Not pregnant
Informed Consent

Exclusion Criteria:

HIV positive
Pregnant
Seriously ill

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paul EM Fine, VMD, PhD	London School of Hygiene and Tropical Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karonga Prevention Study		Chilumba	Karonga District	PO Box 36	Malawi
Redbridge and Waltham Forest Primary Care Trust

Measure	Description	Time Frame
Delayed-type hypersensitivity
cytokine responses (eg IFNg) to mycobacterial antigens