Phase Ib Open Label, Randomized, Controlled, Dose-Escalation Study to Evaluate Safety and Immunogenicity of VPM1002 in Comparison With BCG in Healthy Volunteers in South Africa

NCT01113281 Phase 1 COMPLETED

Goal of VPM is the development of a recombinant urease C-deficient listeriolysin expressing BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against tuberculosis (TB) for residents in endemic areas and persons at risk in non-endemic areas. The new vaccine should be at least as potent as the current strain and should be safer than BCG (Kaufmann, 2007a; Grode et al., 2005). The vaccine is formulated as live lyophilised bacteria to be re-suspended before intradermal injection. The preceding clinical trial in 80 volunteers in Germany indicated immunogenicity and safety being sufficient for proceeding with the clinical development. Hence, the current study is commenced in South Africa, a country highly endemic for tuberculosis. 24 volunteers were randomly allocated to 4 groups each with 6 adult healthy volunteers.

Details

Lead sponsor	Serum Life Science Europe GmbH
Phase	Phase 1
Status	COMPLETED
Enrolment	24
Start date	2010-04
Completion	2011-03

Conditions

• Tuberculosis

Interventions

• VPM1002 live vaccine
• commercially available live vaccine BCG

Primary outcomes

• Safety: physical examination, vital signs, electrocardiogram, liver sonography, laboratory safety parameters, tolerability, recording of concomitant medication and adverse events — baseline, days 2, 7, 14, 28, 56, and month 6

Countries

South Africa