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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00922363
First Posted: June 17, 2009
Last Update Posted: January 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Statens Serum Institut
  Purpose
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 Intervention 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 Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Statens Serum Institut:

Primary Outcome Measures:
  • Adverse events [ Time Frame: one year after first vaccination ]

Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: one year after the first vaccination ]

Enrollment: 38
Study Start Date: October 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00922363


Locations
Netherlands
Department of infectious diseases, C5-P, LUMC
Leiden, Netherlands, NL-2300 RC
Sponsors and Collaborators
Statens Serum Institut
  More Information

Responsible Party: Statens Serum Institut
ClinicalTrials.gov Identifier: NCT00922363     History of Changes
Other Study ID Numbers: ACAF01-01
First Submitted: June 16, 2009
First Posted: June 17, 2009
Last Update Posted: January 21, 2013
Last Verified: January 2013

Keywords provided by Statens Serum Institut:
safety
vaccine
tuberculosis
CAF01
Ag85B-ESAT-6
prevention

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs