A Phase I Trial of a LTK63 Adjuvated Tuberculosis Nasal Subunit Vaccine (Ag85B-ESAT6) (TMUVA-01)
31 oktober 2008 uppdaterad av: St George's, University of London
A Phase I Trial of the Safety and Immunogenicity of an Adjuvated TB Subunit Vaccine (Ag85B-ESAT6 + LTK63) Administered at 0 and 2 Months
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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
9
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
England
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London, England, Storbritannien, SW17 0RE
- St George's Vaccine Institute
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 55 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 1
100 ug H1 antigen alone in BCG naive subjects
|
100 ug H1 antigen in BCG naive subjects
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects
50 ug H1 antigen in BCG immunized subjects
50 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
100 ug H1 antigen in BCG immunized subjects
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
|
|
Experimentell: 2
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects
|
100 ug H1 antigen in BCG naive subjects
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects
50 ug H1 antigen in BCG immunized subjects
50 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
100 ug H1 antigen in BCG immunized subjects
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
|
|
Experimentell: 3
50 ug H1 antigen in BCG immunized subjects
|
100 ug H1 antigen in BCG naive subjects
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects
50 ug H1 antigen in BCG immunized subjects
50 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
100 ug H1 antigen in BCG immunized subjects
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
|
|
Experimentell: 4
50 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
|
100 ug H1 antigen in BCG naive subjects
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects
50 ug H1 antigen in BCG immunized subjects
50 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
100 ug H1 antigen in BCG immunized subjects
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
|
|
Experimentell: 5
100 ug H1 antigen in BCG immunized subjects
|
100 ug H1 antigen in BCG naive subjects
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects
50 ug H1 antigen in BCG immunized subjects
50 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
100 ug H1 antigen in BCG immunized subjects
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
|
|
Experimentell: 6
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
|
100 ug H1 antigen in BCG naive subjects
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects
50 ug H1 antigen in BCG immunized subjects
50 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
100 ug H1 antigen in BCG immunized subjects
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
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.
Tidsram: 8 months
|
8 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
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.
Tidsram: 8 months
|
8 months
|
Samarbetspartners och utredare
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Publikationer och användbara länkar
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Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2007
Primärt slutförande (Faktisk)
1 november 2007
Avslutad studie (Faktisk)
1 februari 2008
Studieregistreringsdatum
Först inskickad
26 februari 2007
Först inskickad som uppfyllde QC-kriterierna
26 februari 2007
Första postat (Uppskatta)
27 februari 2007
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
2 november 2008
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
31 oktober 2008
Senast verifierad
1 oktober 2008
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- TMUVA-01
- FP6-2002-LIFESCIHEA-2.3 503240
- EudraCT Number: 2005-005140-81
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