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

Study Overview
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Brief Summary
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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.

Official Title
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An Open Phase I, Dose-escalating, Clinical 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

Conditions
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Tuberculosis

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female or male adult between 18 and 55 years of age Healthy according to medical history and medical examinations at screening Signed informed consent Prepared to grant authorized persons access to medical records Likely to comply with instructions Exclusion Criteria: History of tuberculosis or known exposure to tuberculosis before (or expected during) the clinical trial Positive Tuberculin Skin Test (TST) result at screening Positive QuantiFERON® -TB Gold In-Tube test result according to the manufacturer's specifications at screening BCG vaccination any time before entering the trial History of or ongoing congenital or acquired immune deficiency, autoimmune disease or thyroid dysfunction Disease affecting the lymphoid organs (Hodgkin's disease, lymphoma, leukaemia, sarcoidosis) ANA-Titer, HBV, HCV, HIV sero-positive at screening C-reactive protein level > 50 mg/L at screening Clinically significant abnormal laboratory test results at screening as assessed by the investigator Severe ongoing viral or bacterial infection that might affect the cell mediated immune response 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 Live vaccine vaccination (MMR, yellow fever, oral typhoid) within 3 months before the first vaccination Immune modulating drugs administration (immunoglobulin, systemic corticosteroids, azathioprine, cyclosporine, infliximab, blood products or vaccines) within 3 months before the first vaccination Known hypersensitivity to any of the vaccine components of the investigational vaccines 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 Pregnant according to a urine pregnancy test at inclusion Females not willing to use contraceptives or breast feeding Has a condition which in the opinion of the investigator is not suitable for participation in the clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 50 µg Ag85B-ESAT-6 alone<br> | Biological: 50 µg Ag85B-ESAT-6 alone<br>* 0.5 mL solution for injection x 2 (2 months interval)<br>|
| Experimental: 50 µg Ag85B-ESAT-6 + 125/25 µg CAF01<br> | Biological: 50 µg Ag85B-ESAT-6 + 125/25 µg CAF01<br>* 0,5 mL suspension for injection x 2 (2 months interval)<br>|
| Experimental: 50 µg Ag85B-ESAT-6 + 313/63 µg CAF01<br> | Biological: 50 µg Ag85B-ESAT-6 + 313/63 µg CAF01<br>* 0.5 mL suspension for injection x 2 (2 months interval)<br>|
| Experimental: 50 µg Ag85B-ESAT-6 + 625/125 µg CAF01<br> | Biological: 50 µg Ag85B-ESAT-6 + 625/125 µg CAF01<br>* 0.5 mL suspension for injection x 2 (2 months interval)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | one year after first vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity |  | one year after the first vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety, vaccine, tuberculosis, CAF01, Ag85B-ESAT-6, prevention