# 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** · PHASE1 · COMPLETED · sponsor: **Statens Serum Institut** · enrollment: 38 (actual)

## Conditions studied

- Tuberculosis

## Interventions

- **BIOLOGICAL:** 50 µg Ag85B-ESAT-6 alone
- **BIOLOGICAL:** 50 µg Ag85B-ESAT-6 + 125/25 µg CAF01
- **BIOLOGICAL:** 50 µg Ag85B-ESAT-6 + 313/63 µg CAF01
- **BIOLOGICAL:** 50 µg Ag85B-ESAT-6 + 625/125 µg CAF01

## Key facts

- **NCT ID:** NCT00922363
- **Lead sponsor:** Statens Serum Institut
- **Sponsor class:** OTHER
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2009-10
- **Primary completion:** 2011-10
- **Final completion:** 2011-10
- **Target enrollment:** 38 (ACTUAL)
- **Last updated:** 2013-01-21


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00922363

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00922363, "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". Retrieved via AI Analytics 2026-06-05 from https://api.ai-analytics.org/clinical/NCT00922363. Licensed CC0.

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