MedTrace Logo

A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis(TB) Subunit Vaccine

NCT01003093 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

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 in healthy BCG-unvaccinated volunteers with no prior history of TB disease or known prior exposure to TB

Conditions

Interventions

BIOLOGICAL

50 microgram antigen (Ag85B + ESAT-6)

0.5 mL suspension for injection x 2 with 2 months interval

BIOLOGICAL

50 microgram antigen (Ag85B + ESAT-6) + 100 nmol KLK + 4 nmol ODN1a

0.5 mL suspension for injection x 2 with 2 months interval

BIOLOGICAL

50 microgram antigen (Ag85B + ESAT-6) + 500 nmol KLK + 20 nmol ODN1a

0.5 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
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2008-03-31
Completion
2008-06-30

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 NCT01003093 on ClinicalTrials.gov