Primary objective:The primary objective is to evaluate the safety of an adjuvated TB subunit vaccine administered in PPD positive volunteers at 0 and 2 months.Secondary objective:The secondary objective is to determine the immunogenicity profile of…
ID
Source
Brief title
Condition
- Mycobacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary variables:
A. Physical examination, including ENT, cardiovasculair, pulmonary,
neurological, gastrointestinal, urogenital and dermatological systems, as well
as injection sites
B. Local adverse events, including pain, erythema, urticaria, asthma,
angiooedema, fatigue, fever, arthralgia, myalgia, hoarseness, dizziness,
malaise, paleness, sweating, nausea, arrhytmia, headache and anaphylaxis
Laboratory safett tests:
D. Blood samples will be tested for RBC, differential WBC, platelets,
hemoglobin, hematocrit, ASAT, ALAT, alkaline phosphatase, lactate
dehydrogenase, gamma GT, albumin, bilirubin, creatine, glucose, potassium,
sodium
E. Urine samples will be tested for glucose, protein and sediment.
Secondary outcome
Secondary variables:
A. Detection by elispot of IFN-gamma spot-forming cells in PBMC's after
stimulation with Ag85B, Esat-6 and H1
B. Detection by ELISA of IFN-gamma production in supernatants of PBM stimulated
with Ag85B, ESAT and H1.
C. Detection by ELISA of IgG antibodies to recombinant proteins Ag85B, ESAT-6
and H! in serum/plasma.
D. Detection by ELISA of TNF-gamma in serum before and one day after
vaccination.
Quantiferon TB-Gold In Tube Test
Background summary
Tuberculosis (TB) is caused by Mycobacterium tuberculosis (MT), an
intracellulair pathogen. One third of the worlds population is infected with TB
and 8-10 milllion TB-diseases and 2-3 million deaths. The only currently
available vaccine against TB is BCG. BCG has shown to protect against severe
childhood forms of TB. However, the protective efficacy in adult pulmonary
tuberculosis varies considerably, from 85% to 0%, and a new, improved second
generation of TB vaccine is, thereforme, urgently needed.
Study objective
Primary objective:
The primary objective is to evaluate the safety of an adjuvated TB subunit
vaccine administered in PPD positive volunteers at 0 and 2 months.
Secondary objective:
The secondary objective is to determine the immunogenicity profile of an
adjuvated TB subunit vaccine administered in PPD positive volunteers at 0 and 2
months.
Study design
A single-centre, open, phase 1 trial with fixed antigen and adjuvant, including
2 groups of 10 volunteers. In total 20 PPD-positives volunteers, vaccinated
twice, 0 and two months. A Data Safety Monitoring Board (DSMB) decided if it is
safe to continue with the second vaccination.
Intervention
two times a vaccination within two months, intramuscularly into deltoid muscle.
Study burden and risks
Two times a vaccination. Nine times blood withdrawn, Mantoux-skin-test.
Risks: anafylactic shock, to vaccine components
Artillerivej 5
DK-2300 Copenhagen S
Denemarken
Artillerivej 5
DK-2300 Copenhagen S
Denemarken
Listed location countries
Age
Inclusion criteria
BCG-group: BCG-vaccinated > two years before, PPD+ (range 6-15mm) or any documented value between 6-15mm on medical file in the past, with no active, chronic or past TB disease as confirmed by chest X ray, negative Quantiferon-TB gold in Tube test and negative 6-day lymphocyte tests;Infection-group: known to be diagnosed with latent TB, PPD+, previously TB infected but with no active disease confirmed by chest X ray, may have received chemoprophylaxis but with no TB treatment/chemoprophylaxis within the preceding 2 years, positive Quantiferon-TB Gold In Tube test and or positive 6-day lymphocyte test
Healthy based on medical examination/history at the inclusion
Age between 18 and 55 ears
Signed informed consent
Exclusion criteria
Granulomatous disease other then TB
Vaccinated with live vaccine 3 months before the first vaccination
Administration of immune modilating drugs 3 months before first vaccination
HBV, HCV, or HIV sero-positive
Participation in another clinical trial
Known hypersensitivity to any of the vaccine components
Laboratory parameters outside of normal range judged by PI to be clinically relevant
Pregnant women/planned pregnancy and/or breastfeeding within the trail period
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-006366-42-NL |
| CCMO | NL16267.000.07 |