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A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis (TB) Subunit Vaccine in Purified Protein Derivative (PPD) Positive Volunteers

NCT00929396 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-01-21

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit vaccine administered at 0 and 2 months.

Conditions

Interventions

BIOLOGICAL

50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)

o,5 mL suspension for injection x 2 with 2 months interval

BIOLOGICAL

50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)

o,5 mL suspension for injection x 2 with 2 months interval

Sponsors & Collaborators

  • Statens Serum Institut

    lead OTHER

Principal Investigators

  • Jaap van Dissel, MD, Prof. · Leiden University Medical Centre

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • Netherlands

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 NCT00929396 on ClinicalTrials.gov