EMaBS TB Vaccine Study

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

July 1, 2019

Primary Completion Date

May 24, 2021

Study Completion Date

May 24, 2021

Conditions
SafetyImmunogenicity
Interventions
BIOLOGICAL

ChAdOx185A

ChAdOx1 85A is an adenoviral vaccine based on a vector that is a chimpanzee adenovirus isolate Y25 expressing the M.tb antigen 85A. Adenoviruses are attractive candidates for use as viral vectors and have been used as vaccine vectors for a number of conditions; however, the use has been limited by the high level of anti-vector immunity present in humans in whom adenovirus is a ubiquitous infection. This has led to the consideration of simian adenoviruses, which are not known to cause pathology or illness in humans and to which the prevalence of anti-vector antibodies is low. The ChAdOx1 vector has been developed by the University of Oxford and been used with different inserts for vaccination, for example the vaccine ChAdOx1 NP+M1 has demonstrated an excellent safety profile in the Influenza trial FLU004. A BCG - ChAdOx1 85A - MVA85A prime boost regime is more protective than BCG alone in mice.

BIOLOGICAL

MVA85A

Modified vaccinia virus Ankara (MVA) is a highly-attenuated strain of vaccinia virus which cannot replicate in human cells. It is known to be highly immunogenic in UK adults but has been less immunogenic in African children and infants. It is suitable for use as a viral vector in a prime-boost regime in new vaccine development. It has an excellent safety record as it was administered intradermally to approximately 120,000 people during the smallpox eradication campaign, and has since been used in numerous clinical trials of candidate vaccines against viral, mycobacterial and protozoal infections.

BIOLOGICAL

BCG

BCG is the only vaccine currently approved for use against Tuberculosis.

Trial Locations (2)

Unknown

MRC/UVRI and LSHTM Uganda Research Unit, Entebbe Hospital, Entebbe

OX3 7LJ

Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford, Churchill Hospital, Oxford

All Listed Sponsors
collaborator

MRC/UVRI and LSHTM Uganda Research Unit

OTHER

lead

University of Oxford

OTHER

NCT03681860 - EMaBS TB Vaccine Study | Biotech Hunter | Biotech Hunter