A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis(TB) Subunit Vaccine

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit vaccine administered at 0 and 2 months in healthy BCG-unvaccinated volunteers with no prior history of TB disease or known prior exposure to TB

Official Title
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A Safety and Immunogenicity Phase 1 Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31) Administered at 0 and 2 Months

Conditions
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Tuberculosis

Intervention / Treatment
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* Biological: 50 microgram antigen (Ag85B + ESAT-6)
* Biological: 50 microgram antigen (Ag85B + ESAT-6) + 100 nmol KLK + 4 nmol ODN1a
* Biological: 50 microgram antigen (Ag85B + ESAT-6) + 500 nmol KLK + 20 nmol ODN1a


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male Healthy based on medical examination/history at the inclusion Age between 18 and 55 years Signed informed consent Prepared to grant authorized persons access to the medical records The volunteer is likely to comply with instructions Exclusion Criteria: Known exposure to TB before (or expected during) the trial Prior BCG vaccination Granulomatous disease (by chest X-ray, autoimmune screen) Vaccinated with live vaccine 3 months before first vaccination Administration of immune modulating drugs (steroids, immunosuppressive drugs or immunoglobulins) 3 months before the first vaccination HBV, HCV or HIV sero-positive (HBsAg, HBsAb, HBc total and IgM ab and HCV, HIV-1 and HIV2 ab) Participation in other clinical trials Positive Mantoux or QuantiFERON-TB Gold Known hypersensitivity to any of the vaccine components Laboratory parameters outside of normal ranges considered clinically relevant

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

Sexes Eligible for Study
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Male

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: Antigen group + high adjuvans<br>The antigen group + high adjuvans group received two injections of antigen (Ag85B + ESAT-6) + IC31 (500 nmol KLK + 20 nmol ODN1a) two months apart. | Biological: 50 microgram antigen (Ag85B + ESAT-6) + 500 nmol KLK + 20 nmol ODN1a<br>* 0.5 mL suspension for injection x 2 with 2 months interval<br>* Other names: Antigen H1 + IC31;|
| Experimental: Antigen group<br>The antigen group received two injections of antigen (Ag85B + ESAT-6) two months apart. | Biological: 50 microgram antigen (Ag85B + ESAT-6)<br>* 0.5 mL suspension for injection x 2 with 2 months interval<br>* Other names: Antigen H1;|
| Experimental: Antigen + low adjuvans group<br>The antigen group + low adjuvans group received two injections of antigen (Ag85B + ESAT-6) + IC31 (100 nmol KLK + 4 nmol ODN1a) two months apart. | Biological: 50 microgram antigen (Ag85B + ESAT-6) + 100 nmol KLK + 4 nmol ODN1a<br>* 0.5 mL suspension for injection x 2 with 2 months interval<br>* Other names: Antigen H1 + IC31;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical examination. Local adverse events. Systemic adverse events. Laboratory safety tests including urine safety tests. |  | From the first vaccination until 8 months after the first vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection by ELISPOT of IFN gamma spot-forming cells in PBMC. Detection by ELISA of IFN gamma production in supernatants of PBMC. Detection of humoral response (IgG) by ELISA. |  | From first vaccination until 36 months after first vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tuberculosis, Vaccine, Ag85B, ESAT-6, IC31