NCT00480714

Brief Summary

To assess the immunogenicity of M. bovis BCG (SSI strain), given intrademally in the standard dose used in clinical practice and to measure the development of the immune response in the first six months after administration. M. bovis BCG is a fully licensed vaccine that has been in routine clinical use for the last 50 years. It is the most widely administered vaccine in the world today and has an excellent safety record.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2003

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2007

Completed
Last Updated

May 31, 2007

Status Verified

May 1, 2007

First QC Date

May 30, 2007

Last Update Submit

May 30, 2007

Conditions

TB

Keywords

TBVaccineBCG

Outcome Measures

Primary Outcomes (1)

  • The induction of T-cell responses

    6 months

Interventions

BCG (SSI Strain)BIOLOGICAL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult aged 18-65 years.
  • Normal medical history and physical examination.
  • Normal urine dipstick, blood count, liver enzymes, and creatinine.

You may not qualify if:

  • Exposure to TB/BCG vaccination at any point. Previous residence in a TB endemic area.
  • Clinically significant history of skin disorder (eczema, psoriasis, etc.), allergy, immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness, psychiatric disorder, drug or alcohol abuse.
  • Oral or systemic steroid medication or the use of immunosuppressive agents.
  • Positive HIV or core HBV antibody test.
  • Positive Heaf test
  • Positive ANA or serum anti-DNA antibody.
  • Confirmed pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oxford, CCVTM, Churchill Hospital

Oxford, Oxfordshire, OX3 7LJ, United Kingdom

Location

Related Publications (2)

  • McShane H, Pathan AA, Sander CR, Keating SM, Gilbert SC, Huygen K, Fletcher HA, Hill AV. Recombinant modified vaccinia virus Ankara expressing antigen 85A boosts BCG-primed and naturally acquired antimycobacterial immunity in humans. Nat Med. 2004 Nov;10(11):1240-4. doi: 10.1038/nm1128. Epub 2004 Oct 24.

    PMID: 15502839RESULT

  • Pathan AA, Sander CR, Fletcher HA, Poulton I, Alder NC, Beveridge NE, Whelan KT, Hill AV, McShane H. Boosting BCG with recombinant modified vaccinia ankara expressing antigen 85A: different boosting intervals and implications for efficacy trials. PLoS One. 2007 Oct 24;2(10):e1052. doi: 10.1371/journal.pone.0001052.

    PMID: 17957238DERIVED

Study Officials

  • Helen I McShane

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 30, 2007

First Posted

May 31, 2007

Study Start

March 1, 2003

Study Completion

September 1, 2003

Last Updated

May 31, 2007

Record last verified: 2007-05

Locations

GB(1)