NCT00440544

Brief Summary

The purpose of this study is to determine whether a subunit tuberculosis vaccine given as two nasal immunizations composed of a hybrid protein antigen from M. tuberculosis virus mixed with a toxoid adjuvant, causes untoward adverse reactions when administered to healthy adult volunteers. Both subjects who have not received Bacillus Calmette-Guerin (BCG) and subjects who have already received BCG will be enrolled. An initial evaluation of immune responses to the vaccine will also be undertaken.

Trial Health

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Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

November 3, 2008

Status Verified

October 1, 2008

Enrollment Period

10 months

First QC Date

February 26, 2007

Last Update Submit

October 31, 2008

Conditions

Tuberculosis

Keywords

Tuberculosisvaccinenasal immunization

Outcome Measures

Primary Outcomes (1)

  • To evaluate the safety profile (medical examinations, adverse events and laboratory safety tests) of a nasal TB subunit vaccine with and without adjuvant given as two doses with 2 months interval.

    8 months

Secondary Outcomes (1)

  • To evaluate the cell mediated and humoral immunogenicity profile of a nasal TB subunit vaccine with and without adjuvant, given as two doses with 2 months interval.

    8 months

Study Arms (6)

1

EXPERIMENTAL

100 ug H1 antigen alone in BCG naive subjects

Biological: Ag85B-ESAT6 fusion protein H1

2

EXPERIMENTAL

100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects

Biological: Ag85B-ESAT6 fusion protein H1

3

EXPERIMENTAL

50 ug H1 antigen in BCG immunized subjects

Biological: Ag85B-ESAT6 fusion protein H1

4

EXPERIMENTAL

50 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects

Biological: Ag85B-ESAT6 fusion protein H1

5

EXPERIMENTAL

100 ug H1 antigen in BCG immunized subjects

Biological: Ag85B-ESAT6 fusion protein H1

6

EXPERIMENTAL

100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects

Biological: Ag85B-ESAT6 fusion protein H1

Interventions

Ag85B-ESAT6 fusion protein H1BIOLOGICAL

100 ug H1 antigen in BCG naive subjects

1

Eligibility Criteria

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

You may qualify if:

  • Signed informed consent
  • Male or female subjects, aged between 18 and 55 years
  • Willing and likely to be able to comply with the trial procedures
  • Prepared to grant authorized persons access to their medical records
  • BCG-non-vaccinated (i.e., absence of a BCG-scar)
  • Negative Mantoux skin test
  • BCG-vaccinated (i.e., presence of a BCG-scar)

You may not qualify if:

  • History of TB or known exposure to TB
  • Radiological findings on chest X ray compatible with previous or current infection with tuberculosis
  • Positive QuantiFERON® TB-Gold test Evidence of previous, current or latent tuberculosis
  • Evidence of previous, current or latent tuberculosis
  • History of severe organ-system diseases
  • Known hypersensitivity to any of the vaccine components
  • History of allergic disorders
  • Vaccinated with other vaccine within 3 months before first vaccination
  • Congenital and/or acquired immune diseases
  • Administration of systemic immune modulating drugs (steroids, immunosuppressive drugs or immunoglobulin) within 3 months before the first vaccination (topical steroids not included)
  • Autoimmune diseases
  • HIV, HBV and HCV sero-positive
  • Established diagnosis of a neurological or neuromuscular disease, and specifically any history of abnormality with respect to sense of smell (olfactory nerve dysfunction), or previous or current facial nerve paralysis
  • Congenital or acquired abnormalities or disorders related to nasal and nasopharyngeal cavities
  • Current use of any medication taken through the nasal/inhalatory route including cocaine or other drugs
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St George's Vaccine Institute

London, England, SW17 0RE, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • David JM Lewis, MD

    St George's, University of London, UK

    PRINCIPAL INVESTIGATOR

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

February 26, 2007

First Posted

February 27, 2007

Study Start

January 1, 2007

Primary Completion

November 1, 2007

Study Completion

February 1, 2008

Last Updated

November 3, 2008

Record last verified: 2008-10

Locations

GB(1)