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OpenTrials
Completed

NCT Number: NCT00793702

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

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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Disease Gram-Positive Bacterial Infections Infections Mycobacterium Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rigshospitalet, Epidemiklinikken

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rdESAT-6 + rCFP-10

Biological

rdESAT-6 + rCFP-10 skin test administered intradermally by the mantoux injection technique

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Statens Serum Institut

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 19, 2008
Registry last updated
Jan 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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