Ignite Creation Date:
2024-05-06 @ 1:12 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01751048
Status:
COMPLETED
Last Update Posted:
2017-01-02
First Post:
2012-12-13
Brief Title:
LEISH-F3 GLA-SE and the LEISH-F3 MPL-SE Vaccine
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase 1 Clinical Trial to Evaluate the Safety Tolerability and Immunogenicity of the Vaccine Candidates LEISH-F3 GLA-SE LEISH-F3 MPL-SE and LEISH-F3 SE in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2015-05
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:
Investigational products LEISH-F3 recombinant protein antigen GLA-SE adjuvant leishmaniasis vaccine and LEISH-F3 recombinant protein antigen MPL-SE adjuvant leishmaniasis vaccine Stage of development Phase 1 clinical development Healthy adult subjects 18 to 49 will be recruited through a US site Primary objective To evaluate the safety and tolerability of the LEISH-F3 GLA-SE vaccine and the LEISH-F3 MPL-SE vaccine following intramuscular IM administration of 20 µg of LEISH-F3 together with 2 or 5 µg of GLA-SE or 10 µg of MPL-SE on Days 0 28 and 168 Secondary objective To assess the immunogenicity of LEISH-F3 formulated with GLA-SE MPL-SE or SE by evaluating IgG antibody responses to LEISH-F3 at Days 0 28 56 168 196 and 365 and T cell responses to LEISH-F3 at Days 0 14 42 168 182 and 365 Each subjects duration of participation will be about 18 months
Detailed Description:
Leishmaniasis is a disease caused by protozoan parasites of the genus Leishmania The parasites are transmitted from an animal or human reservoir through the bite of infected female phlebotomine sand flies This study is a randomized open-label clinical trial designed to evaluate the safety tolerability and immunogenicity of the LEISH-F3 recombinant protein antigen formulated with GLA-SE MPL-SE or SE adjuvant in healthy adults 18 to 49 years of age Each subjects duration of participation will be about 18 months Subjects will receive a total of 3 doses of vaccine which will be given by intramuscular injection on Days 0 28 and 168 The volume of each vaccine dose will be 05 mL A computerized system will be used to acquire any data regarding halting criteria throughout the study Primary objective is to evaluate the safety and tolerability of LEISH-F3 formulated with GLA-SE MPL-SE or SE following intramuscular administration of 20 µg of LEISH-F3 together with 5 µg of GLA-SE 10 µg of MPL-SE or SE alone Secondary objective is to assess the immunogenicity of LEISH-F3 formulated with GLA-SE MPL-SE or SE by evaluating IgG antibody responses to LEISH-F3 at Days 0 28 56 168 196 and 365 and T cell responses to LEISH-F3 at Days 0 14 42 168 182 and 365 A substudy will be performed using up to 12 subjects from each Study Group Groups 1 2 and 3 and an additional 12 subjects to serve as controls This substudy will investigate whether as in murine cells cell surface markers CD11a CD49d can be used as a surrogate to identify protective immune CD4 T cells in human subjects receiving a vaccine antigen
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 |
|---|---|---|---|
| HHSN272200800008C | None | None | None |