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Dose-Escalation Study on Safety and Immunogenicity of VPM1002 in Comparison to BCG in Healthy Volunteers in South Africa

NCT01113281 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-11-21

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 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.

Conditions

Interventions

BIOLOGICAL

VPM1002 live vaccine

BIOLOGICAL

commercially available live vaccine BCG

Sponsors & Collaborators

  • Farmovs-Parexel Bloemfontein, Republic of South Africa (Clinical Site)

    collaborator UNKNOWN

  • Triclinium Johannesburg, RSA (Monitoring and Overall Management of the study)

    collaborator UNKNOWN

  • University of Stellenbosch

    collaborator OTHER

  • HJ-CTC George, RSA (Statistics & Report)

    collaborator UNKNOWN

  • Serum Life Science Europe GmbH

    lead INDUSTRY

Principal Investigators

  • Mada Ferreira, MD · Farmovs-Parexel, Bloemfontein, RSA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-12-31
Completion
2011-03-31

Countries

  • South Africa

Study Locations

More Related Trials

Entities

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 NCT01113281 on ClinicalTrials.gov