NCT02088892

Brief Summary

TB031 is a challenge study comparing two different strains of the Bacille Calmette-Guérin (BCG) vaccine at standard and high dose.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 22, 2015

Status Verified

January 1, 2015

Enrollment Period

10 months

First QC Date

March 10, 2014

Last Update Submit

January 21, 2015

Conditions

Tuberculosis

Keywords

BCG challenge study

Outcome Measures

Primary Outcomes (1)

  • Quantity of BCG at challenge site

    To evaluate and compare the amount of BCG (measured by CFU count and PCR) from a biopsy taken from the intradermal BCG challenge site in healthy BCG-naïve adults receiving either BCG SSI or BCG Tice at either standard or high dose

    At Day 14

Secondary Outcomes (1)

  • Immune response markers

    Up to Day 14

Other Outcomes (2)

  • Local and systemic adverse events

    Up to Day 28

  • Mycobacterial Growth Inhibition Assays

    Up to day 14

Study Arms (5)

Group A

EXPERIMENTAL

10 BCG-naïve subjects receiving intradermal BCG SSI at standard dose (2-8 x 10\^5 cfu) followed by a punch biopsy at the challenge site 14 days later.

Drug: BCG SSI

Group B

EXPERIMENTAL

10 BCG-naïve subjects receiving BCG Tice at standard dose (2-8 x 10\^5 cfu) followed by a punch biopsy at the challenge site 14 days later.

Drug: BCG Tice

Group C

EXPERIMENTAL

10 BCG-naïve subjects receiving intradermal BCG SSI at high dose (6-24 x 10\^5 cfu) followed by a punch biopsy at the challenge site 14 days later.

Drug: BCG SSI

Group D

EXPERIMENTAL

10 BCG-naïve subjects receiving intradermal BCG Tice at high dose (6-24 x 10\^5 cfu) followed by a punch biopsy at the challenge site 14 days later.

Drug: BCG Tice

Group E

EXPERIMENTAL

8-12 BCG-naïve subjects receiving the optimal strain and dose of intradermal BCG identified from preliminary results obtained from Group A, B, C and D, followed by a punch biopsy at the challenge site 14 days later.

Drug: BCG SSIDrug: BCG Tice

Interventions

BCG SSIDRUG

Intradermal injection

Also known as: Bacille Calmette-Guérin Statens Serum Institute (BCG SSI)
Group AGroup CGroup E
BCG TiceDRUG

Intradermal injection

Also known as: Bacille Calmette-Guérin Tice
Group BGroup DGroup E

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteers must meet all of the following criteria to enter the study:
  • Healthy adult aged 18-55 years
  • BCG naïve
  • Resident in or near Oxford (for CCTVM) or Birmingham (for WTCRF) for the duration of the study period
  • No relevant findings in medical history or on physical examination
  • Allow the Investigators to discuss the volunteer's medical history with their GP
  • Use effective contraception for the duration of the study period (females only)
  • Agreement to refrain from blood donation during the duration of the study
  • Give written informed consent
  • Allow the Investigator to register volunteer details with a confidential database to prevent concurrent entry into clinical trials
  • Able and willing (in the Investigator's opinion) to comply with all the study requirements

You may not qualify if:

  • Volunteers must meet none of the following criteria to enter the study:
  • Laboratory evidence at screening of latent M. tb infection as indicated by a positive ELISPOT response to ESAT6 or CFP10 antigens
  • Clinical, radiological, or laboratory evidence of current active TB disease
  • Previous vaccination with BCG, or any candidate TB vaccine
  • Within the last year had close household contact with an individual with smear positive pulmonary tuberculosis
  • Clinically significant history of skin disorder, allergy, immunodeficiency (including HIV), cancer (except BCC or CIS), cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, neurological illness, psychiatric disorder, drug or alcohol abuse
  • History of serious psychiatric condition
  • Concurrent oral or systemic steroid medication or the concurrent use of other immunosuppressive agents
  • History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the challenge agent
  • Any abnormality of screening blood or urine tests that is deemed to be clinically significant or that may compromise the safety of the volunteer in the study
  • Positive HBsAg, HCV or HIV antibodies
  • Female confirmed pregnant or intention to become pregnant during study period, or currently lactating
  • Current involvement in another trial that involves regular blood tests or an investigational medicinal product
  • Use of an investigational medicinal product or non-registered drug, live vaccine, or investigational medical device for four weeks prior to dosing with the study challenge agent
  • Administration of immunoglobulins and/or any blood products within the three months preceding the planned challenge date
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

The Wellcome Trust Clinical Research Facility, University of Birmingham

Birmingham, West Midlands, B15 2TB, United Kingdom

Location

Related Publications (1)

  • Minhinnick A, Harris S, Wilkie M, Peter J, Stockdale L, Manjaly-Thomas ZR, Vermaak S, Satti I, Moss P, McShane H. Optimization of a Human Bacille Calmette-Guerin Challenge Model: A Tool to Evaluate Antimycobacterial Immunity. J Infect Dis. 2016 Mar 1;213(5):824-30. doi: 10.1093/infdis/jiv482. Epub 2015 Oct 8.

    PMID: 26450421DERIVED

Related Links

MeSH Terms

Conditions

Tuberculosis

Interventions

BCG Vaccine

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Tuberculosis VaccinesBacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Helen McShane

    University of Oxford

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2014

First Posted

March 17, 2014

Study Start

March 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

January 22, 2015

Record last verified: 2015-01

Locations

GB(2)