Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001906
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Safety and Immunogenicity of a Vaccine for Cutaneous Leishmaniasis Using Recombinant Human Interleukin-12 and Aluminum Hydroxide Gel as Adjuvants
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Safety and Immunogenicity of a Vaccine for Cutaneous Leishmaniasis Using Recombinant Human Interleukin-12 and Aluminum Hydroxide Gel as Adjuvants
Status:
COMPLETED
Status Verified Date:
2000-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 III trial
Detailed 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 III trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-I-0091 | None | None | None |