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TuberculosisPhase 1NCT00548444

T-Cell Turnover Following Vaccination With MVA85A

A Phase 1 study testing MVA85A and Deuterated glucose infusion in people with Tuberculosis, run by University of Oxford at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Tuberculosis
What is being tested?
MVA85A and Deuterated glucose infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited Kingdom
Study dates
Oct 2007to Jan 2010
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • University of Oxford

    Oxford, Oxfordshire, OX3 7LJ

Other trials in United Kingdom

About this study

Official title: Measurement of Human T-Cell Turnover Following Vaccination With the Tuberculosis Vaccine MVA85A

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

Read the detailed description

MVA85A is a promising new vaccine designed to prevent tuberculosis (TB) by dramatically boosting pre-existing responses to BCG, the only licensed vaccine against the disease at present. In BCG vaccinated individuals it induces a strong immune response. However little is known about the evolution of that response or of the kinetics of T-cells (the immune cells that respond to the vaccine) immediately following vaccination. Crucially, the outcome of this process may determine long term protection from disease.

This study aims to define the early immune response to MVA85A and is the first to apply a safe, non-radioactive 'label' - deuterium - to measure T-cell turnover following vaccination. This labelling approach has been used successfully by the study collaborators to examine immune cell kinetics in human clinical studies in the UK over the last 8 years. The resulting data will provide insight into the immune response generated by MVA85A and aid in the future design and modification of other T-cell inducing vaccines.

Group 1 (Immune responses only)

Previous human studies of MVA85A have described the immune response to vaccination at fixed timepoints but not in between. The investigators will vaccinate four volunteers and measure immune responses daily for 14 days. This will provide important new data and aid interpretation of kinetics data from groups 2 and 3.

Groups 2 \& 3 (Labelling)

Eight volunteers will be vaccinated and then receive a timed infusion of deuterated glucose. Blood will be collected during the follow up period to determine the rates of uptake and loss of label in responding immune cells.

Conditions
Tuberculosis
Being tested
MVA85A, Deuterated glucose infusion
Keywords
Tuberculosis, Lymphocyte kinetics, MVA85A, Deuterium
Medical subject headings
Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MVA85ABiological

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

  • 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).

Study groups in NCT00548444
Study groupRoleWhat they receive
Group 1ExperimentalVolunteers will receive a single dose of MVA85A followed by regular blood tests to measure the resulting cellular immune response.
Receives: Biological: MVA85A
Group 2ExperimentalVolunteers will receive a single dose of MVA85A followed by an infusion of labelled (deuterated) glucose and regular blood tests.
Receives: Biological: MVA85A; Other: Deuterated glucose infusion
Group 3ExperimentalVolunteers will receive a single dose of MVA85A followed by an infusion of labelled (deuterated) glucose and regular blood tests.
Receives: Biological: MVA85A; Other: Deuterated glucose infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proliferation and disappearance rates of responding antigen-specific T-cells

    Measured: Within four weeks of vaccination

Secondary outcomes (2)

  1. Immunogenicity

    Measured: Within three months of vaccination

  2. Safety

    Measured: Within three months of vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionJan 2010
  4. Study completionJan 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00548444
Sponsor's protocol ID
TB018
Other IDs
EudraCT number: 2007-001293-8
Status last verified
Jan 2010
First submitted
23 Oct 2007
Last updated
18 Jan 2010
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 15249595

  • 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.

    PubMed 16955142

  • 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.

    PubMed 17483473

  • 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.

    PubMed 15502839

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MVA85A and Deuterated glucose infusion in people with Tuberculosis, run by University of Oxford at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proliferation and disappearance rates of responding antigen-specific T-cells (time frame: Within four weeks of vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00548444, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2010.

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