NCT02391415

Study to Evaluate the Safety and Immunogenicity of VPM1002 in Comparison With BCG in HIV-exposed/-Unexposed Newborn Infants in South Africa

Phase II Double-blind, Randomized, Controlled Study to Evaluate Safety and Immunogenicity of VPM1002 Compared With BCG in HIV-exposed and HIV-unexposed, BCG-naive Newborn Infants

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 416 (actual)
• Sponsor: Serum Institute of India Pvt. Ltd. · Industry
• Sex: All
• Age: 12 Days
• Healthy volunteers: Accepted

Summary

Goal of Serum Institute of India Limited (SIIL) 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. The preceding phase-IIa trial was the first investigation of VPM1002 in newborn infants in a high burden setting in South Africa. The vaccination of HIV-unexposed infants with VPM1002 indicated again safety, tolerability and immunogenicity sufficient to proceed in HIV-exposed infants. The current study is a multiple site trial in South Africa to evaluate safety and immunogenicity in HIV-unexposed and -exposed newborn infants.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	VPM1002	Tuberculosis vaccine
BIOLOGICAL	BCG	commercially available live vaccine BCG
BIOLOGICAL	VPM1002(Hyg+)	Tuberculosis vaccine

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2015-03-18
• Last updated: 2018-04-18

Locations

4 sites across 1 country: South Africa