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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:
Information provided by (Responsible Party):
Statens Serum Institut
ClinicalTrials.gov Identifier:
NCT00922363
First received: June 16, 2009
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Tuberculosis
U.S. FDA Resources

Further study details as provided by Statens Serum Institut:

Primary Outcome Measures:
  • Adverse events [ Time Frame: one year after first vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: one year after the first vaccination ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922363

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

No publications provided

Responsible Party: Statens Serum Institut
ClinicalTrials.gov Identifier: NCT00922363     History of Changes
Other Study ID Numbers: ACAF01-01
Study First Received: June 16, 2009
Last Updated: January 18, 2013
Health Authority: Netherlands: Ministry of Health, Welfare and Sport
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on May 19, 2013