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

Sponsor

Statens Serum Institut (Other)

Overall Status

Completed

CT.gov ID

NCT00922363

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tuberculosis	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	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Adverse events [one year after first vaccination]

Secondary Outcome Measures

Immunogenicity [one year after the first vaccination]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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