NCT00427830

Brief Summary

This is a phase I study to examine the safety and immunogenicity of MVA85A delivered intradermally into the deltoid region in volunteers who have recieved BCG in the past 20 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2003

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

May 1, 2003

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2007

Completed
Last Updated

January 29, 2007

Status Verified

December 1, 2006

First QC Date

January 25, 2007

Last Update Submit

January 26, 2007

Conditions

Tuberculosis

Keywords

Mycobacterium tuberculosis85A antigenRecombinant Modified Vaccinia AnkaraPhase I studyImmunogenicityBCG

Outcome Measures

Primary Outcomes (1)

  • The occurance and severity of local and systemic side effects will be monitored. Vital signs and local reactions will be monitored at 30 and 60 minutes after each immunisation (and after 7 days).

Secondary Outcomes (3)

  • Immunogenicity will be measured: The induction of T cell responses (as measured by an interferon-gamma Elispot assay) will be performed on PBMCs from blood samples taken at the specified time points.

  • Proliferation assays and cytotoxic T cell assays will be performed on strong CD4+ and CD8+ responses respectively.

  • Antibody titres will be measured from frozen plasma samples.

Interventions

MVA85ABIOLOGICAL

Eligibility Criteria

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

You may qualify if:

  • Healthy adult aged 18-55 years.
  • Normal medical history and physical examination.
  • Normal urine dipstick, blood count, liver enzymes, and creatinine.

You may not qualify if:

  • Exposure to TB 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 antibody test, HCV antibody test or positive HBV serology except post-vaccination.
  • Heaf test greater than Grade II
  • Confirmed pregnancy
  • Previous MVA immunisations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford, Churchill Hospital

Oxford, Oxfordshire, OX3 7LJ, United Kingdom

Location

Related Publications (4)

  • 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

  • Tanner R, Kakalacheva K, Miller E, Pathan AA, Chalk R, Sander CR, Scriba T, Tameris M, Hawkridge T, Mahomed H, Hussey G, Hanekom W, Checkley A, McShane H, Fletcher HA. Serum indoleamine 2,3-dioxygenase activity is associated with reduced immunogenicity following vaccination with MVA85A. BMC Infect Dis. 2014 Dec 3;14:660. doi: 10.1186/s12879-014-0660-7.

    PMID: 25466778DERIVED

  • Whelan KT, Pathan AA, Sander CR, Fletcher HA, Poulton I, Alder NC, Hill AV, McShane H. Safety and immunogenicity of boosting BCG vaccinated subjects with BCG: comparison with boosting with a new TB vaccine, MVA85A. PLoS One. 2009 Jun 16;4(6):e5934. doi: 10.1371/journal.pone.0005934.

    PMID: 19529780DERIVED

  • 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

MeSH Terms

Conditions

Tuberculosis

Interventions

MVA 85A

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Helen McShane, MD and PhD

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 25, 2007

First Posted

January 29, 2007

Study Start

May 1, 2003

Study Completion

January 1, 2005

Last Updated

January 29, 2007

Record last verified: 2006-12

Locations

GB(1)