Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076037
Status:
COMPLETED
Last Update Posted:
2021-10-14
First Post:
2004-01-13
Brief Title:
Safety of and Immune Response to a New HIV Vaccine HIV CTL MEP
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a CTL Multi-Epitope Peptide HIV Vaccine Formulated With RC529-SE With or Without GM-CSF in Healthy HIV-1 Uninfected Adult Participants
Status:
COMPLETED
Status Verified Date:
2021-10
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:
The effectiveness of a vaccine can be improved by using a prime boost strategy or by using an adjuvant A prime boost strategy is the administration of one type of vaccine the primer followed by the administration of another type vaccine the booster An adjuvant is a substance that can enhance the immune response when given at the same time as a vaccine
This study will evaluate the safety of and immune response to a vaccine designed to be used as part of a prime boost strategy The study will also evaluate the vaccine when given with an adjuvant The vaccine in this study is not produced from live HIV or from infected cells It does not contain HIV and it cannot cause HIV infection
This study will evaluate the safety of and immune response to a vaccine designed to be used as part of a prime boost strategy The study will also evaluate the vaccine when given with an adjuvant The vaccine in this study is not produced from live HIV or from infected cells It does not contain HIV and it cannot cause HIV infection
Detailed Description:
Prime-boost vaccine strategies are aimed at inducing different types of immune responses and enhancing the overall immune response a result that may not occur with a single type of vaccine This trial will evaluate the safety and immunogenicity of an HIV multi-epitope peptide cytotoxic T lymphocyte HIV CTL MEP vaccine developed as part of a prime-boost strategy and designed to be administered in combination with an HIV DNA vaccine
The HIV CTL MEP vaccine is a mixture of four synthetic peptides each containing one of three different HIV CTL epitopes derived from env or gag The use of multiple conserved CTL epitopes will address the extraordinary diversity found among HIV strains The vaccine is administered with RC529-SE an analogue of monophosphoryl lipid A The vaccineadjuvant combination will be evaluated with or without coadministration of granulocyte-macrophage colony-stimulating factor GM-CSF
Participants will be randomly assigned to receive either the vaccine with the RC529-SE adjuvant the vaccine with both adjuvants RC529-SE and GM-CSF or a placebo The vaccine adjuvants and placebo will all be given as an injection into the upper arm Participants will have 11 study visits Study visits will include a physical exam medical interview and blood and urine tests Participants will receive an injection at three of these visits study entry and Months 1 and 3 Participants will be followed for 1 year after the last injection
The HIV CTL MEP vaccine is a mixture of four synthetic peptides each containing one of three different HIV CTL epitopes derived from env or gag The use of multiple conserved CTL epitopes will address the extraordinary diversity found among HIV strains The vaccine is administered with RC529-SE an analogue of monophosphoryl lipid A The vaccineadjuvant combination will be evaluated with or without coadministration of granulocyte-macrophage colony-stimulating factor GM-CSF
Participants will be randomly assigned to receive either the vaccine with the RC529-SE adjuvant the vaccine with both adjuvants RC529-SE and GM-CSF or a placebo The vaccine adjuvants and placebo will all be given as an injection into the upper arm Participants will have 11 study visits Study visits will include a physical exam medical interview and blood and urine tests Participants will receive an injection at three of these visits study entry and Months 1 and 3 Participants will be followed for 1 year after the last injection
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 |
|---|---|---|---|
| 10122 | REGISTRY | DAIDS ES Registry Number | None |