A Phase I Trial of a LTK63 Adjuvated Tuberculosis Nasal Subunit Vaccine (Ag85B-ESAT6) (TMUVA-01)
This study has been terminated.
(Safety Issues)
Sponsor:
St George's, University of London
Collaborators:
Statens Serum Institut
Novartis Vaccines
European Union
Information provided by:
St George's, University of London
ClinicalTrials.gov Identifier:
NCT00440544
First received: February 26, 2007
Last updated: October 31, 2008
Last verified: October 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Tuberculosis |
Biological: Ag85B-ESAT6 fusion protein H1 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by St George's, University of London:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 9 |
| Study Start Date: | January 2007 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
100 ug H1 antigen alone in BCG naive subjects
|
Biological: Ag85B-ESAT6 fusion protein H1
100 ug H1 antigen in BCG naive subjects
|
|
Experimental: 2
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects
|
Biological: Ag85B-ESAT6 fusion protein H1
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects
|
|
Experimental: 3
50 ug H1 antigen in BCG immunized subjects
|
Biological: Ag85B-ESAT6 fusion protein H1
50 ug H1 antigen in BCG immunized subjects
|
|
Experimental: 4
50 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
|
Biological: Ag85B-ESAT6 fusion protein H1
50 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
|
|
Experimental: 5
100 ug H1 antigen in BCG immunized subjects
|
Biological: Ag85B-ESAT6 fusion protein H1
100 ug H1 antigen in BCG immunized subjects
|
|
Experimental: 6
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
|
Biological: Ag85B-ESAT6 fusion protein H1
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
|
Detailed Description:
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 BCG and subjects who have already received BCG will be enrolled. An initial evaluation of immune responses to the vaccine will also be undertaken using flow cytometry to enumerate antigen specific IFNg containing T cells; ELISPOT to determine IFNg secreting antigen specific T cells; serology and nasal wash antibody.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00440544
Locations
| United Kingdom | |
| St George's Vaccine Institute | |
| London, England, United Kingdom, SW17 0RE | |
Sponsors and Collaborators
St George's, University of London
Statens Serum Institut
Novartis Vaccines
European Union
Investigators
| Principal Investigator: | David JM Lewis, MD | St George's, University of London, UK |
More Information
Additional Information:
No publications provided
| Responsible Party: | David JM Lewis, Principal Investigator, SGUL |
| ClinicalTrials.gov Identifier: | NCT00440544 History of Changes |
| Other Study ID Numbers: | TMUVA-01, EudraCT Number: 2005-005140-81, FP6-2002-LIFESCIHEA-2.3 503240 |
| Study First Received: | February 26, 2007 |
| Last Updated: | October 31, 2008 |
| Health Authority: | United Kingdom: Research Ethics Committee United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by St George's, University of London:
|
Tuberculosis vaccine nasal immunization |
Additional relevant MeSH terms:
|
Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on June 18, 2013