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Trial on the Safety of a New Liposomal Adjuvant System, CAF01, When Given With the Tuberculosis Subunit Vaccine Ag85B-ESAT-6 as Two Injections With Two Months Interval to Healthy Adult Volunteers

NCT00922363 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

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 CAF01, administering 50 µg Ag85B-ESAT-6 alone and 50 µg Ag85B-ESAT-6 with three escalating CAF01 dose levels, to four groups of healthy volunteers, injecting two doses with two months interval.

Conditions

Interventions

BIOLOGICAL

50 µg Ag85B-ESAT-6 alone

0.5 mL solution for injection x 2 (2 months interval)

BIOLOGICAL

50 µg Ag85B-ESAT-6 + 125/25 µg CAF01

0,5 mL suspension for injection x 2 (2 months interval)

BIOLOGICAL

50 µg Ag85B-ESAT-6 + 313/63 µg CAF01

0.5 mL suspension for injection x 2 (2 months interval)

BIOLOGICAL

50 µg Ag85B-ESAT-6 + 625/125 µg CAF01

0.5 mL suspension for injection x 2 (2 months interval)

Sponsors & Collaborators

  • Statens Serum Institut

    lead OTHER

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
2009-10-31
Primary Completion
2011-10-31
Completion
2011-10-31

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 NCT00922363 on ClinicalTrials.gov