NCT00548444

Brief Summary

This study examines the early immune response to a new vaccine (MVA85A) being developed to combat tuberculosis (TB).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2007

Typical duration for phase_1

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

October 1, 2007

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

January 18, 2010

Status Verified

January 1, 2010

Enrollment Period

2.3 years

First QC Date

October 23, 2007

Last Update Submit

January 15, 2010

Conditions

Tuberculosis

Keywords

TuberculosisLymphocyte kineticsMVA85ADeuterium

Outcome Measures

Primary Outcomes (1)

  • Proliferation and disappearance rates of responding antigen-specific T-cells

    Within four weeks of vaccination

Secondary Outcomes (2)

  • Immunogenicity

    Within three months of vaccination

  • Safety

    Within three months of vaccination

Study Arms (3)

Group 1

EXPERIMENTAL

Volunteers will receive a single dose of MVA85A followed by regular blood tests to measure the resulting cellular immune response.

Biological: MVA85A

Group 2

EXPERIMENTAL

Volunteers will receive a single dose of MVA85A followed by an infusion of labelled (deuterated) glucose and regular blood tests.

Biological: MVA85AOther: Deuterated glucose infusion

Group 3

EXPERIMENTAL

Volunteers will receive a single dose of MVA85A followed by an infusion of labelled (deuterated) glucose and regular blood tests.

Biological: MVA85AOther: Deuterated glucose infusion

Interventions

MVA85ABIOLOGICAL

Vaccine. Dose: 1 x 10\^8 plaque-forming units (pfu) given by intradermal injection into the deltoid region of the upper arm.

Group 1Group 2Group 3
Deuterated glucose infusionOTHER

6,6D2-glucose given as a timed intravenous infusion. The total dose of deuterated glucose will be 1g/kg volunteer body weight (up to a maximum of 60g).

Group 2Group 3

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult aged 18 to 50 years
  • Immunization with BCG greater than 12 months prior to enrolment in the study
  • Resident in or near Oxford for the duration of the study
  • Able and willing (in the investigator's opinion) to comply with all study requirements
  • Given written informed consent
  • Willing to allow the investigator to request medical information from, or discuss the volunteer's medical history with the volunteer's General Practitioner
  • Willing to allow the investigator to register volunteer details with a confidential database to prevent concurrent entry into clinical trials
  • For women only, willingness to practice continuous effective contraception during the study
  • Agreement to refrain from blood donation during the course of the study

You may not qualify if:

  • Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
  • Prior receipt of a recombinant MVA vaccine
  • Screening test suggesting the possibility of latent TB infection- i.e. Elispot positive (greater than 17 sfc/million PBMC) in any ESAT6 peptide or CFP10 peptide pool
  • Any clinically significant abnormal finding on screening blood tests or urinalysis (see Appendix B for guidance on study reference ranges)
  • Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
  • Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
  • Any history of anaphylaxis
  • History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
  • History of serious psychiatric condition
  • Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
  • Seropositive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (antibodies to HCV)
  • Pregnancy, lactation or willingness/intention to become pregnant during the study
  • Any other chronic illness requiring hospital specialist supervision
  • Any other significant disease, disorder or finding, which, in the opinion of the investigator, may either put the volunteer at risk because of participation in the study, or may influence the result of the study, or the volunteer's ability to participate fully in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oxford

Oxford, Oxfordshire, OX3 7LJ, United Kingdom

Location

Related Publications (4)

  • Macallan DC, Wallace D, Zhang Y, De Lara C, Worth AT, Ghattas H, Griffin GE, Beverley PC, Tough DF. Rapid turnover of effector-memory CD4(+) T cells in healthy humans. J Exp Med. 2004 Jul 19;200(2):255-60. doi: 10.1084/jem.20040341. Epub 2004 Jul 12.

    PMID: 15249595BACKGROUND

  • Vukmanovic-Stejic M, Zhang Y, Cook JE, Fletcher JM, McQuaid A, Masters JE, Rustin MH, Taams LS, Beverley PC, Macallan DC, Akbar AN. Human CD4+ CD25hi Foxp3+ regulatory T cells are derived by rapid turnover of memory populations in vivo. J Clin Invest. 2006 Sep;116(9):2423-33. doi: 10.1172/JCI28941.

    PMID: 16955142BACKGROUND

  • Asquith B, Zhang Y, Mosley AJ, de Lara CM, Wallace DL, Worth A, Kaftantzi L, Meekings K, Griffin GE, Tanaka Y, Tough DF, Beverley PC, Taylor GP, Macallan DC, Bangham CR. In vivo T lymphocyte dynamics in humans and the impact of human T-lymphotropic virus 1 infection. Proc Natl Acad Sci U S A. 2007 May 8;104(19):8035-40. doi: 10.1073/pnas.0608832104. Epub 2007 May 1.

    PMID: 17483473BACKGROUND

  • 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: 15502839BACKGROUND

MeSH Terms

Conditions

Tuberculosis

Interventions

MVA 85A

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Helen I McShane, MBBS, MRCP, BSc, PhD

    University of Oxford

    PRINCIPAL INVESTIGATOR

  • Adrian VS Hill, MA, BM BCh, DPhil, DM

    University of Oxford

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 23, 2007

First Posted

October 24, 2007

Study Start

October 1, 2007

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

January 18, 2010

Record last verified: 2010-01

Locations

GB(1)