Safety, False-Positive Reactions and Sensitizing Properties of Leishmania Tropica Skin Test Antigen
Palabras clave
Abstracto
fechas
Verificado por última vez: | 09/30/2013 |
Primero enviado: | 03/02/2008 |
Inscripción estimada enviada: | 03/09/2008 |
Publicado por primera vez: | 03/10/2008 |
Última actualización enviada: | 10/27/2013 |
Última actualización publicada: | 11/19/2013 |
Fecha de los primeros resultados enviados: | 07/18/2012 |
Fecha de los primeros resultados de CC enviados: | 12/03/2012 |
Fecha de los primeros resultados publicados: | 12/05/2012 |
Fecha de inicio real del estudio: | 07/31/2008 |
Fecha estimada de finalización primaria: | 08/31/2009 |
Fecha estimada de finalización del estudio: | 12/31/2009 |
Condición o enfermedad
Intervención / tratamiento
Biological: Leishmania tropica Skin Test Antigen (LtSTA)
Biological: Leishmania tropica Skin Test Antigen Placebo (Placebo)
Fase
Grupos de brazos
Brazo | Intervención / tratamiento |
---|---|
Active Comparator: LtSTA 15 ug Naive volunteers tested with 15 ug injection of LtSTA. Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10. | |
Active Comparator: LtSTA 30 ug Naive volunteers tested with 30 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin testes were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10. | |
Active Comparator: LtSTA 50 ug Naive volunteers tested with 50 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin testes were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10. |
Criterio de elegibilidad
Edades elegibles para estudiar | 18 Years A 18 Years |
Sexos elegibles para estudiar | All |
Acepta voluntarios saludables | si |
Criterios | Inclusion Criteria: - Male or Female in good health; - Age 18 - 60 years; - No past history of leishmaniasis or prior participation in a Leishmania study; - No prior skin test with a Leishmania antigen; - No occupational, residential, or travel exposure to Leishmania; - Positive Candin® or Trichophyton skin test (>= 5 mm induration). Exclusion Criteria: - History of adult atopic dermatitis, contact dermatitis to multiple agents, unexplained urticaria, or asthma; - Active allergic rhinitis or conjunctivitis; - History of allergy or reactions to phenol, polysorbate 80, or glycerol; - Medications: currently taking (within the last month) antihistamines or recent history of taking (within the last 1 year) corticosteroids, immunosuppressants; - Splenectomy; - Active medical disease*; *Active Medical Disease: Any active physical or psychiatric condition that may increase the risks associated with participation in the study or interferes with the interpretation of study results. Included chronic medical illnesses are cardiovascular disease, renal insufficiency, chronic respiratory illness, cirrhosis, chronic hepatitis, chronic pancreatitis, chronic diarrhea, malnutrition, malignancy, autoimmune disease, and asthma. - Pregnancy or lactating; - Immunization within 4 weeks; - History of leishmaniasis; - Occupational exposure to Leishmania; - Prior participation in a Leishmania study; - Prior skin test with Leishmania antigen; - Travel history to Leishmania endemic areas; - Abnormal screening lab results; - Keloid scar formation |
Salir
Medidas de resultado primarias
1. Sensitizing Effects of LtSTA in Leishmania Naive Adults [62 days]
Medidas de resultado secundarias
1. The Safety of 15, 30 and 50µg/0.1mL Doses of LtSTA in Healthy Adult Volunteers Who Have Had no Known Previous Exposure to Leishmania Parasites [74 days]