Tuberculosis Clinical Trial
Official title:
A Clinical Challenge Study to Quantify BCG at the Challenge Site of Healthy Volunteers Receiving Either Intradermal BCG SSI or BCG TICE at Standard or High Dose
TB031 is a challenge study comparing two different strains of the Bacille Calmette-Guérin (BCG) vaccine at standard and high dose.
Currently, to assess vaccine efficacy against tuberculosis (TB) there is no alternative to
large randomized controlled trials. These efficacy trials for novel TB vaccines are
difficult, long and very costly. For this reason there is an urgent need for a valid,
reliable, and strong correlate of protection which can help distinguish between candidate TB
vaccines undergoing phase I trials, and thereby allow the vaccine development field to
advance more quickly, and in a more cost-effective manner.
This study aims to address the current lack of immunological correlates in the TB vaccine
field. As an alternative to phase II field trials, human challenge models can provide an
evaluation of preliminary efficacy of vaccine candidates. Challenge models, with their
concept of deliberate infectious challenge of human volunteers, have been well established
for pathogens such as malaria, typhoid and dengue, and these models have greatly facilitated
vaccine development. At present there is no safe human challenge model of Mycobacterium
tuberculosis (M. tb) infection to enable proof-of-concept efficacy evaluation of candidate
vaccines.
Whilst scientists cannot use M. tb as a challenge agent to evaluate efficacy in a clinical
trial for safety and ethical reasons, they can use another mycobacterium, attenuated
Mycobacterium bovis, as a surrogate for M. tb infection. Attenuated Mycobacterium bovis is
the mycobacterial strain in BCG and is safe to use in humans. An effective vaccine against
M. tb should also be effective against BCG. After injection into humans, BCG replicates, and
an effective TB vaccine should reduce this BCG replication. The BCG challenge model is based
on this premise. In the human BCG challenge model, BCG is administered intradermally and the
degree of BCG growth suppression is quantified by analysing the tissue obtained in a punch
biopsy of volunteers' skin over the BCG 'challenge' site.
This study aims to use two different strains of BCG, each at standard and high dose, to
optimise this BCG challenge model.
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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