Primary:The primary objective is to evaluate the safety profile of an adjuvated Tb subunit vaccine (CAF01) administered in 50 µg Ag85B-Esat-6 alone, 50 µg Ag85B-Esat-6 alone with three escalating CAF01 dose levels, to four groups of healthy…
ID
Source
Brief title
Condition
- Mycobacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety variables:
- Adverse reactions with onset between the first vaccination and 24 weeks after
the second vaccination either identified during medical examinations, as diary
records, or during safety interviews
- Changes form baseline in safety laboratory test values 1 day, 7 days and 6
weeks after the first and second vaccinations and 24 weeks after the second
vaccination.
Secondary outcome
Immunogenicity variables
- Changes from baseline in Ag85B-Esat-6 induced IFN-gamma release from PBMC's
measured by ELISA, 1 week and 6 weeks after the first and second vaccinations
and 24 and 44 weeks after the second vaccination.
- Changes from baseline in Ag85B-ESAT6 IFN-gamma spot forming cells measured by
ELISPOT, 1 week and 6 weeks after the first and second vaccinations and 24 and
44 weeks after the second vaccination.
- Changes from baseline in serum Ig-G antibodies against Ag85B-ESAT-6, 6 weeks
after the first and second vaccinations and 24 and 44 weeks after the second
vaccination.
Background summary
Title:
A safety and immunogenicity phase 1 trial with an adjuvated TB subunit vaccine
(Ag85B - Esat-6 + CAF01) administered in PPD positive volunteers at 0 and 2
months.
Background:
Tuberculosis (TB) is caused by Mycobacterium tuberculosis (MT), an
intracellular pathogen. One third of the worlds population is infected with TB,
8-10 milion suffer from TB-disease and 2-3 million die annualy. Currently the
only available vaccine against TB is BCG. BCG protects against severe childhood
forms of TB. However, the protective efficacy in adult pulmonary tuberculosis
varies considerably, from 85% to 0%. A new improved second generation TB
vaccine is therefore urgently needed.
Study objective
Primary:
The primary objective is to evaluate the safety profile of an adjuvated Tb
subunit vaccine (CAF01) administered in 50 µg Ag85B-Esat-6 alone, 50 µg
Ag85B-Esat-6 alone with three escalating CAF01 dose levels, to four groups of
healthy volunteers at 0 and 2 months, injecting two doses.
Secondary:
The secondary objective is to determine the immunogenicity profile of an
adjuvant TB subunit vaccine (CAF01) administered in 50 µg Ag85B-Esat-6 alone,
50 µg Ag85B-Esat-6 alone with three escalating CAF01 dose levels, to four
groups of healthy volunteers at 0 and 2 months, injecting two doses.
Study design
A single-centre, open, phase 1 trial with a fixed antigen but a variable doses
of adjuvant, including four groups of volunteers. In total 37 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 vaccinations over a two month period, intramuscularly into deltoid muscle.
Study burden and risks
Twice a vaccination. Ten times blood withdrawal, Mantoux-skin-test.
Risks: anafylactic shock caused by the vaccine.
Artillerivej 5
DK-2300 Copenhagen S
DK
Artillerivej 5
DK-2300 Copenhagen S
DK
Listed location countries
Age
Inclusion criteria
Female and male (18-55 years)
Healthy
Exclusion criteria
History of tuberculosis or known exposure
Positive Tuberculin Skin Test and/or positive Quantiferon
BCG vaccination
Thyroid dysfunction
Disease affecting the lymphoid organs
ANA-titer, HBV, HCV, HIV
C-reactive protein level >50 mg/l
Live vaccine vaccination within 3 months before the first vaccination
Intake of another clinical trial product/vaccine within 3 months from the first vaccination or participation in previous clinical trials with the Ag85B-Esat-6 antigen.
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 | EUCTR2008-006003-23-NL |
| CCMO | NL26270.000.09 |