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Safety and Risk of Sensitisation of the rdESAT-6 + rCFP-10 Skin Test Following Repeated Intradermal Administration

Primary Purpose

Tuberculosis

Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
rdESAT-6 + rCFP-10
Sponsored by
Statens Serum Institut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Tuberculosis focused on measuring tuberculosis, diagnosis, ESAT-6, CFP-10, skin test, Skin test for the diagnosis of tuberculosis infection

Eligibility Criteria

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

Inclusion Criteria:

  1. Has signed an informed consent
  2. Is willing and likely to be able to comply with the trial procedures
  3. Is female/male non-black adult ≥ 18 years and ≤ 55 years of age
  4. Is healthy according to a medical examination, medical history and laboratory investigations at inclusion
  5. Is prepared to grant authorized persons access to their medical records

Exclusion Criteria:

  1. Has a history of tuberculosis or has had a known contact to a person with active tuberculosis
  2. Has a positive QuantiFERON-TB Gold In Tube test result at inclusion
  3. Laboratory parameters outside of normal range judged by principal investigator to be clinically significant and/or abnormal glucose or protein levels in a urine sample at inclusion
  4. Has been in treatment with a product which is likely to modify the immune response within 3 months prior to the day of inclusion (e.g., immunoglobulin, systemic corticosteroids, methotrexate, azathioprine, cyclosporine, infliximab or blood products)
  5. Has been vaccinated with a live vaccine within 6 months prior to the day of inclusion (e.g., MMR, yellow fever, or oral typhoid vaccines)
  6. Has a known congenital or acquired immune deficiency
  7. Has a disease affecting the lymphoid organs (e.g., Hodgkin's disease, lymphoma, leukemia, sarcoidosis)
  8. Is known to be infected with HIV, HBV or HCV
  9. Has a severe ongoing viral or bacterial infection that might affect the cell mediated immune response at inclusion
  10. Has a C-reactive protein (CRP) level > 50 mg/L
  11. Has severe scarring, burn, rash, eczema, psoriasis, or any other skin disease at or near the injection site(s)
  12. Has a condition in which repeated blood drawings pose more than minimal risk for the volunteer, such as haemophilia, other coagulation disorders, or significantly impaired venous access
  13. Is actively participating in another clinical trial or has participated in previous clinical trials investigating the rdESAT-6 skin test reagent
  14. Is pregnant according to urine pregnancy test at inclusion
  15. Is a female not willing to use contraceptives or is breastfeeding
  16. Has a condition which in the opinion of the investigator is not suitable for participation in the study

Sites / Locations

  • Rigshospitalet, Epidemiklinikken

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

A

B

C

D

E

Arm Description

two injections 0.01 µg rdESAT-6 + rCFP-10 (6 weeks interval)

two injections 0.01 µg rdESAT-6 + rCFP-10 (12 weeks interval)

two injections 0.1 µg rdESAT-6 + rCFP-10 (6 weeks interval)

two injections 0.1 µg rdESAT-6 + rCFP-10 (12 weeks interval)

one injection 1.0 µg rdESAT-6 + rCFP-10

Outcomes

Primary Outcome Measures

Local and systemic adverse events with onset after the FIRST (0.01, 0.1 and 1.0 µg) or SECOND (0.01 and 0.1 µg) injection

Secondary Outcome Measures

The diameter of induration at the second injection site measured transversely to the long axis of the forearm

Full Information

First Posted
November 17, 2008
Last Updated
January 18, 2013
Sponsor
Statens Serum Institut
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1. Study Identification

Unique Protocol Identification Number
NCT00793702
Brief Title
Safety and Risk of Sensitisation of the rdESAT-6 + rCFP-10 Skin Test Following Repeated Intradermal Administration
Official Title
An Open Phase I Clinical Trial on the Safety and Risk of Sensitisation by Escalating Doses and Repeated Injections of the rdESAT-6 + rCFP-10 Skin Test Reagent Following Intradermal Administration to Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (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 primary objective is to assess the safety of three dose levels (0.01, 0.1 and 1.0 µg) of the rdESAT-6 + rCFP-10 skin test reagent when injected into healthy adults. The secondary objective is to assess the risk of sensitisation of 0.01 and 0.1 µg rdESAT-6 + rCFP-10 when injected twice with time intervals of 6 or 12 weeks to healthy adults.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
tuberculosis, diagnosis, ESAT-6, CFP-10, skin test, Skin test for the diagnosis of tuberculosis infection

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
two injections 0.01 µg rdESAT-6 + rCFP-10 (6 weeks interval)
Arm Title
B
Arm Type
Experimental
Arm Description
two injections 0.01 µg rdESAT-6 + rCFP-10 (12 weeks interval)
Arm Title
C
Arm Type
Experimental
Arm Description
two injections 0.1 µg rdESAT-6 + rCFP-10 (6 weeks interval)
Arm Title
D
Arm Type
Experimental
Arm Description
two injections 0.1 µg rdESAT-6 + rCFP-10 (12 weeks interval)
Arm Title
E
Arm Type
Experimental
Arm Description
one injection 1.0 µg rdESAT-6 + rCFP-10
Intervention Type
Biological
Intervention Name(s)
rdESAT-6 + rCFP-10
Intervention Description
rdESAT-6 + rCFP-10 skin test administered intradermally by the mantoux injection technique
Primary Outcome Measure Information:
Title
Local and systemic adverse events with onset after the FIRST (0.01, 0.1 and 1.0 µg) or SECOND (0.01 and 0.1 µg) injection
Time Frame
onset between the first injection and 28 days after the second injection
Secondary Outcome Measure Information:
Title
The diameter of induration at the second injection site measured transversely to the long axis of the forearm
Time Frame
72 hours after the second injection

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: Has signed an informed consent Is willing and likely to be able to comply with the trial procedures Is female/male non-black adult ≥ 18 years and ≤ 55 years of age Is healthy according to a medical examination, medical history and laboratory investigations at inclusion Is prepared to grant authorized persons access to their medical records Exclusion Criteria: Has a history of tuberculosis or has had a known contact to a person with active tuberculosis Has a positive QuantiFERON-TB Gold In Tube test result at inclusion Laboratory parameters outside of normal range judged by principal investigator to be clinically significant and/or abnormal glucose or protein levels in a urine sample at inclusion Has been in treatment with a product which is likely to modify the immune response within 3 months prior to the day of inclusion (e.g., immunoglobulin, systemic corticosteroids, methotrexate, azathioprine, cyclosporine, infliximab or blood products) Has been vaccinated with a live vaccine within 6 months prior to the day of inclusion (e.g., MMR, yellow fever, or oral typhoid vaccines) Has a known congenital or acquired immune deficiency Has a disease affecting the lymphoid organs (e.g., Hodgkin's disease, lymphoma, leukemia, sarcoidosis) Is known to be infected with HIV, HBV or HCV Has a severe ongoing viral or bacterial infection that might affect the cell mediated immune response at inclusion Has a C-reactive protein (CRP) level > 50 mg/L Has severe scarring, burn, rash, eczema, psoriasis, or any other skin disease at or near the injection site(s) Has a condition in which repeated blood drawings pose more than minimal risk for the volunteer, such as haemophilia, other coagulation disorders, or significantly impaired venous access Is actively participating in another clinical trial or has participated in previous clinical trials investigating the rdESAT-6 skin test reagent Is pregnant according to urine pregnancy test at inclusion Is a female not willing to use contraceptives or is breastfeeding Has a condition which in the opinion of the investigator is not suitable for participation in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pernille Nyholm Tingskov
Organizational Affiliation
Statens Serum Institut
Official's Role
Study Director
Facility Information:
Facility Name
Rigshospitalet, Epidemiklinikken
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
20593018
Citation
Bergstedt W, Tingskov PN, Thierry-Carstensen B, Hoff ST, Aggerbeck H, Thomsen VO, Andersen P, Andersen AB. First-in-man open clinical trial of a combined rdESAT-6 and rCFP-10 tuberculosis specific skin test reagent. PLoS One. 2010 Jun 25;5(6):e11277. doi: 10.1371/journal.pone.0011277.
Results Reference
derived

Learn more about this trial

Safety and Risk of Sensitisation of the rdESAT-6 + rCFP-10 Skin Test Following Repeated Intradermal Administration

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