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

Tuberculosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00922363
• Other study ID #: ACAF01-01
• Status: Completed
• Phase: Phase 1
• First received: June 16, 2009
• Last updated: January 18, 2013
• Start date: October 2009
• Est. completion date: October 2011

Study information

• Verified date: January 2013
• Source: Statens Serum Institut
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Ministry of Health, Welfare and SportNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tuberculosis

Intervention

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

Locations

Country	Name	City	State
Netherlands	Department of infectious diseases, C5-P, LUMC	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Statens Serum Institut

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events		one year after first vaccination	Yes
Secondary	Immunogenicity		one year after the first vaccination	No