Clinical Trials Logo
  1. Home
  2. Cutaneous Leishmaniasis
  3. NCT00001906

Safety and Immunogenicity of a Vaccine for Cutaneous Leishmaniasis Using Recombinant Human Interleukin-12 and Aluminum Hydroxide Gel as Adjuvants

Cutaneous Leishmaniasis Clinical Trial

Official title:
Safety and Immunogenicity of a Vaccine for Cutaneous Leishmaniasis Using Recombinant Human Interleukin-12 and Aluminum Hydroxide Gel as Adjuvants

Clinical Trial Summary

While vaccination against cutaneous leishmaniasis, a chronic ulcerating protozoan infection of the skin, has been possible for decades using live parasites, the production and storage of live cultures are difficult. Since inoculation occasionally leads to severe infection, most experts now advocate against their use. We have shown excellent protection using a "heat-killed" vaccine that combines autoclaved leishmania antigen with recombinant human interleukin-12 (rhIL-12) and aluminum hydroxide gel as adjuvants in a rhesus macaque model of disease. To assess the safety and immunogenicity of this vaccine in humans, we now propose a rhIL-12 dose escalation Phase I/II trial.

Clinical Trial Description

While vaccination against cutaneous leishmaniasis, a chronic ulcerating protozoan infection of the skin, has been possible for decades using live parasites, the production and storage of live cultures are difficult. Since inoculation occasionally leads to severe infection, most experts now advocate against their use. We have shown excellent protection using a "heat-killed" vaccine that combines autoclaved leishmania antigen with recombinant human interleukin-12 (rhIL-12) and aluminum hydroxide gel as adjuvants in a rhesus macaque model of disease. To assess the safety and immunogenicity of this vaccine in humans, we now propose a rhIL-12 dose escalation Phase I/II trial. ;

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00001906
Study type Interventional
Source National Institutes of Health Clinical Center (CC)
Contact
Status Completed
Phase Phase 1
Start date April 1999
Completion date May 2001
View Details
See also
  Status Clinical Trial Phase
Completed NCT01988909 - WR 279,396 for the Treatment of Cutaneous Leishmaniasis Phase 2
Enrolling by invitation NCT00737386 - Frequency of Parasite Infection in Hyraxes and Sandflies During Outbreak of Leishmania Tropica Epidemic in The West Bank N/A
Enrolling by invitation NCT00840359 - Study of the Efficacy of Daylight Activated Photodynamic Therapy in the Treatment of Cutaneous Leishmaniasis Phase 2
Completed NCT00233545 - Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia Phase 2
Completed NCT01462500 - Pharmacokinetics of Miltefosine in Children and Adults Phase 4
Completed NCT01011309 - A Study of the Efficacy and Safety of the LEISH-F2 + MPL-SE Vaccine for Treatment of Cutaneous Leishmaniasis Phase 2
Completed NCT01301924 - Comparison of Standard and Alternative Antimonial Dosage in Patients With American Cutaneous Leishmaniasis Phase 2/Phase 3
Not yet recruiting NCT02281669 - Prospective Observational Study of Intralesional Treatment With Pentostam in Cutaneous Leishmaniasis Israeli Patients N/A
Completed NCT01464242 - Add-on Study of Pentoxifylline in Cutaneous Leishmaniasis Phase 2/Phase 3
Completed NCT01790659 - Phase 3 Study of Walter Reed (WR) 279,396 and Paromomycin Alone for the Treatment of Cutaneous Leishmaniasis in Panama Phase 3
Completed NCT01050907 - Miltefosine to Treat Mucocutaneous Leishmaniasis Phase 2
Completed NCT04340128 - Efficacy of Intra-lesional Injections of Glucantime Once a Week or Twice a Week in the Treatment of Anthroponotic Cutaneous Leishmaniasis (ACL) Phase 3
Terminated NCT00317629 - Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis Phase 3
Completed NCT00351520 - Efficacy Trial on Oral Miltefosine in Comparison With Glucantime in the Treatment of ACL Caused by L. Tropica Phase 3
Completed NCT01381055 - Antimony Plus Pentoxifylline in Cutaneous Leishmaniasis Phase 2/Phase 3
Completed NCT01050777 - Efficacy of Topical Liposomal Form of Drugs in Cutaneous Leishmaniasis Phase 0
Completed NCT01380314 - Oral Miltefosine Plus Topical Imiquimod to Treat Cutaneous Leishmaniasis Phase 2
Terminated NCT01380301 - Treatment of Cutaneous Leishmaniasis With a Combination of Miltefosine and Antimony Phase 2
Completed NCT00703924 - Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: A Phase 2 Study in the Old World Phase 2
Completed NCT00344084 - Surveillance for Leishmaniasis Skin Lesions in Mali