Tuberculosis Clinical Trial
Official title:
Safety and Immunogenicity of Candidate Tuberculosis (TB) Vaccine MVA85A Administered by the Intramuscular Route and the Intradermal Route: a Phase I Randomised Active Controlled Trial
This is a phase I study that will compare the safety and immunogenicity of candidate tuberculosis (TB) vaccine MVA85A administered by the intramuscular route and the intradermal route in healthy adult individuals who have been previously vaccinated with Bacillus Calmette-Guerin (BCG).
We postulate that the intramuscular route is not inferior to the intradermal route of
administration of MVA85A in BCG vaccinated adults when evaluated for safety and
immunogenicity.
If MVA85A can be given safely by intramuscular route and it is at least equally immunogenic
and efficacious in a prime-boost strategy, then it would probably be the preferred route in
subsequent phase II and III trials. There are several reasons for this:
- Reduced pain associated with injection.
- Reduced local reaction at the injection site.
- More straightforward procedure; less technically demanding; less time consuming.
- Easier production and storage of vaccine.
- Larger volume of vaccine can be given.
Trials of MVA85A to date have established 1 x 10^8 pfu as the optimal dose for intradermal
injection in adults. We therefore intend to administer this same dose intramuscularly in
order to directly compare the two routes for both safety and immunogenicity. These results
will guide future trials in which the intramuscular route, if safe, could be further
evaluated at either higher or lower dose depending on immunogenicity at 1 x 10^8 pfu dosage.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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