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

Phase 1

Completed

• Conditions: 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

• Registration Number: NCT00922363
• Lead Sponsor: Statens Serum Institut

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-06-16
• Study First Submitted QC: 2009-06-16
• Study First Posted: 2009-06-17
• Study Start: 2009-10
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-18
• Last Update Posted: 2013-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1. Female or male adult between 18 and 55 years of age
2. Healthy according to medical history and medical examinations at screening
3. Signed informed consent
4. Prepared to grant authorized persons access to medical records
5. Likely to comply with instructions

Exclusion Criteria

1. History of tuberculosis or known exposure to tuberculosis before (or expected during) the clinical trial
2. Positive Tuberculin Skin Test (TST) result at screening
3. Positive QuantiFERON® -TB Gold In-Tube test result according to the manufacturer's specifications at screening
4. BCG vaccination any time before entering the trial
5. History of or ongoing congenital or acquired immune deficiency, autoimmune disease or thyroid dysfunction
6. Disease affecting the lymphoid organs (Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
7. ANA-Titer, HBV, HCV, HIV sero-positive at screening
8. C-reactive protein level > 50 mg/L at screening
9. Clinically significant abnormal laboratory test results at screening as assessed by the investigator
10. Severe ongoing viral or bacterial infection that might affect the cell mediated immune response
11. A condition in which repeated blood drawings pose more than minimal risk for the subject, such as haemophilia, other coagulation disorders, or significantly impaired venous access
12. Live vaccine vaccination (MMR, yellow fever, oral typhoid) within 3 months before the first vaccination
13. Immune modulating drugs administration (immunoglobulin, systemic corticosteroids, azathioprine, cyclosporine, infliximab, blood products or vaccines) within 3 months before the first vaccination
14. Known hypersensitivity to any of the vaccine components of the investigational vaccines
15. Intake of another clinical trial product/vaccine within 3 months before the first vaccination or participation in previous clinical trials with the Ag85B-ESAT-6 antigen
16. Pregnant according to a urine pregnancy test at inclusion
17. Females not willing to use contraceptives or breast feeding
18. Has a condition which in the opinion of the investigator is not suitable for participation in the clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
50 µg Ag85B-ESAT-6 alone	50 µg Ag85B-ESAT-6 alone	-
50 µg Ag85B-ESAT-6 + 125/25 µg CAF01	50 µg Ag85B-ESAT-6 + 125/25 µg CAF01	-
50 µg Ag85B-ESAT-6 + 313/63 µg CAF01	50 µg Ag85B-ESAT-6 + 313/63 µg CAF01	-
50 µg Ag85B-ESAT-6 + 625/125 µg CAF01	50 µg Ag85B-ESAT-6 + 625/125 µg CAF01	-

Primary Outcome Measures

Name	Time	Method
Adverse events	one year after first vaccination

Secondary Outcome Measures

Name	Time	Method
Immunogenicity	one year after the first vaccination

Trial Locations

Locations (1)

Department of infectious diseases, C5-P, LUMC; 🇳🇱 Leiden, Netherlands