MedTrace Logo

A Safety and Immunogenicity Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31)

NCT01049282 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2015-04-17

No results posted yet for this study

Summary

The study has the following objectives:

Primary objective To evaluate the safety profile of an adjuvanted TB subunit vaccine administered in different antigen/adjuvant formulations at 0 and 2 months Secondary objective To determine the immunogenicity profile of an adjuvanted TB subunit vaccine administered in different antigen/adjuvant formulations at 0 and 2 months.

Conditions

Interventions

BIOLOGICAL

Antigen (Ag85B-ESAT-6)

Solution for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval

BIOLOGICAL

Antigen (Ag85B-ESAT-6) with adjuvant (IC31)

Suspension for injection, 0.5 mL, 50 ug antigen, 2 vaccinations with 2 months interval

Sponsors & Collaborators

  • Statens Serum Institut

    lead OTHER

Principal Investigators

  • Jemal Hussein, MD · Armauer Hansen Research Institue/AHRI/,Ethiopia

  • Peter Bang, Msc · Statens serum Institute/SSI/,Denamrk

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2010-04-30
Completion
2010-04-30

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 NCT01049282 on ClinicalTrials.gov