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

NCT02391415 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2018-04-18

No results posted yet for this study

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

Interventions

BIOLOGICAL

VPM1002

Tuberculosis vaccine

BIOLOGICAL

BCG

commercially available live vaccine BCG

BIOLOGICAL

VPM1002(Hyg+)

Tuberculosis vaccine

Sponsors & Collaborators

  • Serum Life Science Europe GmbH

    collaborator INDUSTRY

  • Triclinium Clinical Trial Project Management

    collaborator UNKNOWN

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

    collaborator UNKNOWN

  • Desmond Tutu TB Centre

    collaborator OTHER

  • The Respiratory and Meningeal Pathogens Research Unit (RMPRU)

    collaborator UNKNOWN

  • South African Tuberculosis Vaccine Initiative

    collaborator OTHER

  • University of Stellenbosch

    collaborator OTHER

  • Serum Institute of India Pvt. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
12 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • South Africa

Study Locations

More Related Trials

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 NCT02391415 on ClinicalTrials.gov