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

NCT01479972 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2013-10-29

No results posted yet for this study

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

Interventions

BIOLOGICAL

VPM1002

Tuberculosis vaccine

BIOLOGICAL

BCG

commercially available live vaccine BCG

Sponsors & Collaborators

  • Children's Infectious Diseases Clinical Research Unit (KID-CRU), South Africa

    collaborator UNKNOWN

  • Triclinium Johannesburg, South Africa

    collaborator UNKNOWN

  • University of Stellenbosch

    collaborator OTHER

  • HJ-CTC George, South Africa

    collaborator UNKNOWN

  • Serum Life Science Europe GmbH

    lead INDUSTRY

Principal Investigators

  • Mark Cotton, MD, Professor · Children's Infectious Diseases Clinical Research Unit (KID-CRU), Tygerberg, South Africa

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
8 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • South Africa

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01479972 on ClinicalTrials.gov