A Phase I Trial of a LTK63 Adjuvated Tuberculosis Nasal Subunit Vaccine (Ag85B-ESAT6)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00440544
• Date of registration: 26/02/2007
• Prospective Registration: No
• Primary sponsor: St George's, University of London
• Public title: A Phase I Trial of a LTK63 Adjuvated Tuberculosis Nasal Subunit Vaccine (Ag85B-ESAT6) TMUVA-01
• Scientific title: A Phase I Trial of the Safety and Immunogenicity of an Adjuvated TB Subunit Vaccine (Ag85B-ESAT6 + LTK63) Administered at 0 and 2 Months
• Date of first enrolment: January 2007
• Target sample size: 9
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00440544
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 1

Countries of recruitment

United Kingdom

Contacts

• Name: David JM Lewis, MD
• Affiliation: St George's, University of London, UK

Key inclusion & exclusion criteria

Inclusion Criteria:

- Signed informed consent

- Healthy, based on medical examination at inclusion

- 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

Additional inclusion criterion for BCG-non-vaccinated subjects:

- BCG-non-vaccinated (i.e., absence of a BCG-scar)

- Negative Mantoux skin test

Additional inclusion criterion for BCG-vaccinated subjects:

- BCG-vaccinated (i.e., presence of a BCG-scar)

Exclusion Criteria:

- 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

- Laboratory parameters outside of normal ranges considered clinically significant

- Pregnant according to urine pregnancy test

- Females not willing to use contraceptives or who are breastfeeding

- Intake of trial medication in other clinical trials within 6 months of the first
vaccination



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Tuberculosis

Intervention(s)

Biological: Ag85B-ESAT6 fusion protein H1

Primary Outcome(s)

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. [Time Frame: 8 months]

Secondary Outcome(s)

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. [Time Frame: 8 months]

Secondary ID(s)

TMUVA-01

FP6-2002-LIFESCIHEA-2.3 503240

EudraCT Number: 2005-005140-81

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novartis Vaccines

European Union

Statens Serum Institut