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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

Primary Purpose

Tuberculosis

Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
50 µg Ag85B-ESAT-6 alone
50 µg Ag85B-ESAT-6 + 125/25 µg CAF01
50 µg Ag85B-ESAT-6 + 313/63 µg CAF01
50 µg Ag85B-ESAT-6 + 625/125 µg CAF01
Sponsored by
Statens Serum Institut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tuberculosis focused on measuring safety, vaccine, tuberculosis, CAF01, Ag85B-ESAT-6, prevention

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of infectious diseases, C5-P, LUMC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

50 µg Ag85B-ESAT-6 alone

50 µg Ag85B-ESAT-6 + 125/25 µg CAF01

50 µg Ag85B-ESAT-6 + 313/63 µg CAF01

50 µg Ag85B-ESAT-6 + 625/125 µg CAF01

Arm Description

Outcomes

Primary Outcome Measures

Adverse events

Secondary Outcome Measures

Immunogenicity

Full Information

First Posted
June 16, 2009
Last Updated
January 18, 2013
Sponsor
Statens Serum Institut
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1. Study Identification

Unique Protocol Identification Number
NCT00922363
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Statens Serum Institut

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
safety, vaccine, tuberculosis, CAF01, Ag85B-ESAT-6, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
50 µg Ag85B-ESAT-6 alone
Arm Type
Experimental
Arm Title
50 µg Ag85B-ESAT-6 + 125/25 µg CAF01
Arm Type
Experimental
Arm Title
50 µg Ag85B-ESAT-6 + 313/63 µg CAF01
Arm Type
Experimental
Arm Title
50 µg Ag85B-ESAT-6 + 625/125 µg CAF01
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
50 µg Ag85B-ESAT-6 alone
Intervention Description
0.5 mL solution for injection x 2 (2 months interval)
Intervention Type
Biological
Intervention Name(s)
50 µg Ag85B-ESAT-6 + 125/25 µg CAF01
Intervention Description
0,5 mL suspension for injection x 2 (2 months interval)
Intervention Type
Biological
Intervention Name(s)
50 µg Ag85B-ESAT-6 + 313/63 µg CAF01
Intervention Description
0.5 mL suspension for injection x 2 (2 months interval)
Intervention Type
Biological
Intervention Name(s)
50 µg Ag85B-ESAT-6 + 625/125 µg CAF01
Intervention Description
0.5 mL suspension for injection x 2 (2 months interval)
Primary Outcome Measure Information:
Title
Adverse events
Time Frame
one year after first vaccination
Secondary Outcome Measure Information:
Title
Immunogenicity
Time Frame
one year after the first vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Department of infectious diseases, C5-P, LUMC
City
Leiden
ZIP/Postal Code
NL-2300 RC
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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