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

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

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.

Study Overview

• Status: Completed
• Conditions: Tuberculosis
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Leiden, Netherlands, NL-2300 RC
    • Department of infectious diseases, C5-P, LUMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse events	one year after first vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
Immunogenicity	one year after the first vaccination

Collaborators and Investigators

• Sponsor: Statens Serum Institut

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: June 16, 2009
• First Submitted That Met QC Criteria: June 16, 2009
• First Posted (Estimate): June 17, 2009

Study Record Updates

• Last Update Posted (Estimate): January 21, 2013
• Last Update Submitted That Met QC Criteria: January 18, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: safety; vaccine; prevention; tuberculosis; CAF01; Ag85B-ESAT-6
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: ACAF01-01