Leprosy Skin Test Antigens Trial

PHASE2CompletedINTERVENTIONAL
Enrollment

260

Participants

Timeline

Start Date

April 30, 2002

Primary Completion Date

September 30, 2009

Study Completion Date

September 30, 2009

Conditions
Leprosy
Interventions
BIOLOGICAL

Tuberculin, Purified Protein Derivative

A tuberculin skin test used to diagnose latent tuberculosis (TB) infection. 2 TU dose

OTHER

MLSA-LAM

Mycobacterium leprae soluble antigen with minimal amounts of immunosuppressive lipoglycans; dosages 0.1 and 1.0 micrograms; administered in sterile diluent 0.9% saline (NaCl).

OTHER

MLCwA

Cell wall-associated proteins of Mycobacterium leprae; dosages 0.1 and 1.0 micrograms; administered in sterile diluent 0.9% saline (NaCl).

BIOLOGICAL

Tuberculin, Purified Protein Derivative

Licensed TB reagent, 100 microliters, 5 TU dose.

OTHER

Placebo

Saline (NaCl) serves as a diluent control in Stage A and B only.

Trial Locations (6)

80523

Colorado State University - Microbiology, Immunology & Pathology, Fort Collins

Unknown

Anandaban Hospital, Kathmandu

Green Pastures Hospitals, Kathmandu

Lalitpur Nursing Campus, Kathmandu

Patan Hospital, Kathmandu

Tribhuvan University - Anandaban Hospital, Kathmandu

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT00128193 - Leprosy Skin Test Antigens Trial | Biotech Hunter | Biotech Hunter