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2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-11 @ 3:43 AM
Study NCT ID:
NCT01181856
Status:
COMPLETED
Last Update Posted:
2011-03-28
First Post:
2010-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Tuberculosis Vaccine, MVA85A, Administered by the Intramuscular Route and the Intradermal Route
Sponsor:
University of Oxford
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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).
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: