NCT01479972

Study to Evaluate Safety and Immunogenicity of VPM1002 in Comparison With BCG in Newborn Infants in South Africa

Phase II Open Label, Randomized, Controlled Study to Evaluate Safety and Immunogenicity of VPM1002 in Comparison With BCG in HIV-unexposed, BCG Naive Newborn Infants in South Africa

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Serum Life Science Europe GmbH · Industry
• Sex: All
• Age: 8 Days
• Healthy volunteers: Accepted

Summary

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 trials in 80 volunteers in Germany and 24 volunteers in Bloemfontein, South Africa indicated immunogenicity and safety being sufficient for proceeding with the clinical development in newborn infants. Hence, the current study is commenced at Stellenbosch University, South Africa. This is the first investigation of VPM1002 in newborn infants.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	VPM1002	Tuberculosis vaccine
BIOLOGICAL	BCG	commercially available live vaccine BCG

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2011-11-28
• Last updated: 2013-10-29

Locations

1 site across 1 country: South Africa