Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052182
Status:
COMPLETED
Last Update Posted:
2007-10-23
First Post:
2003-01-24
Brief Title:
Safety of and Immune System Response to an HIV Vaccine EP HIV-1090 in HIV Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Single Center Phase I Safety and Immunogenicity Study of Epimmune HIV-1 CTL Epitope-Based DNA Vaccine EP HIV-1090 for Immunotherapy of HIV-1 Infected Individuals Receiving Highly Active Antiretroviral Therapy HAART
Status:
COMPLETED
Status Verified Date:
2007-09
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:
HIV-1-infected patients who have been treated with anti-HIV drugs for a long time may have weakened immune responses to HIV The DNA-based vaccine in this study is designed to boost the immune systems responses against many HIV-1 proteins The main purposes of this study are to test the safety of this HIV vaccine EP HIV-1090 and to test whether the vaccine can stimulate immune system responses in people who have HIV-1 infection
Detailed Description:
Significant data support the hypothesis that HIV-specific cytotoxic T lymphocyte CTL responses contribute to the control and potential clearance of the virus Vaccines designed specifically to induce CTL responses are likely to be well suited for treatment of HIV infection The conceptual basis of the EP HIV-1090 vaccine is the use of highly defined CTL epitopes as the vaccine immunogen The vaccine is formulated with a water-soluble polymer that stabilizes and protects the DNA and facilitates uptake by cells Preclinical studies have shown that the vaccine induces strong CTL responses in animal models This study will evaluate the safety and tolerability of the vaccine and the immune response to the vaccine in HIV-1-infected individuals who are being treated with highly active antiretroviral therapy HAART and have a CD4 count of 350 cellsmm3 or more and fully suppressed viral replication on stable HAART
Each patient will receive a total of four immunizations to be given at Day 0 and at Weeks 4 8 and 16 Participants will be randomly assigned to receive either vaccine or placebo Ten patients will be assigned to each dose group eight will receive active vaccine and two will receive placebo The injections will be delivered intramuscularly into the deltoid muscle In addition to undergoing standard safety exams patients will have blood drawn for use in evaluating the immunogenicity of the vaccine The treatment duration will be 16 weeks and patient will be followed for safety and immune responses for an additional 24 weeks after they complete vaccination the total study is estimated to take 18 months
Each patient will receive a total of four immunizations to be given at Day 0 and at Weeks 4 8 and 16 Participants will be randomly assigned to receive either vaccine or placebo Ten patients will be assigned to each dose group eight will receive active vaccine and two will receive placebo The injections will be delivered intramuscularly into the deltoid muscle In addition to undergoing standard safety exams patients will have blood drawn for use in evaluating the immunogenicity of the vaccine The treatment duration will be 16 weeks and patient will be followed for safety and immune responses for an additional 24 weeks after they complete vaccination the total study is estimated to take 18 months
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 |
|---|---|---|---|
| IPCP 01 | None | None | None |