Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002350
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Phase I Trial of APL 400-003 Vaccine Safety and Immune Response Evaluations of Multiple Injections at Escalating Doses in Asymptomatic HIV-Infected Patients
Sponsor:
Apollon
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase I Trial of APL 400-003 Vaccine Safety and Immune Response Evaluations of Multiple Injections at Escalating Doses in Asymptomatic HIV-Infected Patients
Status:
COMPLETED
Status Verified Date:
1997-07
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:
To evaluate safety and immune response in HIV-infected patients treated with multiple injections of APL 400-003 vaccine
PER 22796 AMENDMENT To evaluate the safety of the vaccine when administered via the Biojector 2000 Needle-Free Injection Management System
Facilitated DNA inoculation a new type of DNA vaccine involves direct injection of non-infectious HIV genes into a patients muscle along with agents that promote uptake of the genes into host cells Host cells that have taken up these genes then produce viral proteins in a form that elicits immune responses in the form of antibodies killer T-cells and helper T-cells The safety of this new vaccine approach needs to be assessed
PER 22796 AMENDMENT The Biojector 2000 provides an option for delivering the vaccine without a needle and employs a single-use syringe to avoid cross-contamination
PER 22796 AMENDMENT To evaluate the safety of the vaccine when administered via the Biojector 2000 Needle-Free Injection Management System
Facilitated DNA inoculation a new type of DNA vaccine involves direct injection of non-infectious HIV genes into a patients muscle along with agents that promote uptake of the genes into host cells Host cells that have taken up these genes then produce viral proteins in a form that elicits immune responses in the form of antibodies killer T-cells and helper T-cells The safety of this new vaccine approach needs to be assessed
PER 22796 AMENDMENT The Biojector 2000 provides an option for delivering the vaccine without a needle and employs a single-use syringe to avoid cross-contamination
Detailed Description:
Facilitated DNA inoculation a new type of DNA vaccine involves direct injection of non-infectious HIV genes into a patients muscle along with agents that promote uptake of the genes into host cells Host cells that have taken up these genes then produce viral proteins in a form that elicits immune responses in the form of antibodies killer T-cells and helper T-cells The safety of this new vaccine approach needs to be assessed
PER 22796 AMENDMENT The Biojector 2000 provides an option for delivering the vaccine without a needle and employs a single-use syringe to avoid cross-contamination
Patients are given intramuscular injections of APL 400-003 at one of three doses 30 100 or 300 mcg on day 0 and again at weeks 10 and 20 and followed for 16 weeks after the final dose An 8-week period prior to initial dosing is required for immortalizing the patients PBMCs
PER 22796 AMENDMENT Five patients will be evaluated at the 300 mcg dose with the Biojector 2000
PER 22796 AMENDMENT The Biojector 2000 provides an option for delivering the vaccine without a needle and employs a single-use syringe to avoid cross-contamination
Patients are given intramuscular injections of APL 400-003 at one of three doses 30 100 or 300 mcg on day 0 and again at weeks 10 and 20 and followed for 16 weeks after the final dose An 8-week period prior to initial dosing is required for immortalizing the patients PBMCs
PER 22796 AMENDMENT Five patients will be evaluated at the 300 mcg dose with the Biojector 2000
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| APL 400-003RX101 | None | None | None |