Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001088
Status:
COMPLETED
Last Update Posted:
2008-09-29
First Post:
1999-11-02
Brief Title:
A Phase I Safety and Immunogenicity Trial of the Facilitated HIV-1 Gag-Pol DNA Vaccine APL-400-047 Apollon Inc Given Intramuscularly by Needle and Syringe or Biojector 2000 Needle-Free Jet Injection System in HIV-1 Uninfected Adult Volunteers
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 Safety and Immunogenicity Trial of the Facilitated HIV-1 Gag-Pol DNA Vaccine APL-400-047 Apollon Inc Given Intramuscularly by Needle and Syringe or Biojector 2000 Needle-Free Jet Injection System in HIV-1 Uninfected Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2008-09
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:
To evaluate the safety tolerability and immunogenicity in humans of the APL-400-047 vaccine when administered intramuscularly by needle and syringe at 1 of 3 doses or by Biojector at the intermediate dose AS PER AMENDMENT 0798 To evaluate the tolerability safety and immunogenicity of an increased dose in an additional group of volunteers DNA-based immunization mimics live-attenuated virus vaccination by stimulation of both the humoral and cellular arms of the immune system thus potentially providing the advantages of a live virus vaccination but without the potential risks It is essential that novel vaccine strategies including DNA-based immunizations continue to be developed and enter Phase I human testing because to date no candidate vaccine from any of the approximately 30 AVEG Phase I or II trials has progressed to a Phase III efficacy trial Use of a Biojector jet gun for vaccine delivery may also have potential psychological comfort safety and immunologic advantages over the traditional needle and syringe method of delivery
Detailed Description:
DNA-based immunization mimics live-attenuated virus vaccination by stimulation of both the humoral and cellular arms of the immune system thus potentially providing the advantages of a live virus vaccination but without the potential risks It is essential that novel vaccine strategies including DNA-based immunizations continue to be developed and enter Phase I human testing because to date no candidate vaccine from any of the approximately 30 AVEG Phase I or II trials has progressed to a Phase III efficacy trial Use of a Biojector jet gun for vaccine delivery may also have potential psychological comfort safety and immunologic advantages over the traditional needle and syringe method of delivery
A total of 40 volunteers receive four immunizations each at months 0 1 2 and 6 as follows
10 volunteers are enrolled at the 100 microgram dose given intramuscularly IM by needle and syringe If this dose appears safe and well tolerated through Day 14 20 more volunteers are enrolled at the 300 microgram dose 10 receiving vaccine administered by needle and syringe 10 receiving vaccine administered by Biojector If the 300 microgram dose appears safe and well tolerated through Day 14 in the 10 volunteers who receive intramuscular IM injections with needle and syringe an additional group of volunteers are enrolled at the 1000 microgram dose given with needle and syringe NOTE Within each group of 10 volunteers 8 receive APL-400-047 2 receive control preparation bupivacaine carrier alone AS PER AMENDMENT 0798 An additional group of 12 volunteers will be treated at a dose of 3000 micrograms administered by needle and syringe Ten of these volunteers will receive APL-400-047 formulated with bupivacaine as a facilitating agent the remaining 2 patients will receive control preparation bupivacaine carrier alone AS PER AMENDMENT 42799 Volunteers previously primed with either 300 or 1000 micrograms of the APL-400-047 vaccine receive an additional dose of DNA or control for control volunteers in the original protocol followed one month later by two monthly canarypox or placebo for control volunteers in the original protocol boosts
A total of 40 volunteers receive four immunizations each at months 0 1 2 and 6 as follows
10 volunteers are enrolled at the 100 microgram dose given intramuscularly IM by needle and syringe If this dose appears safe and well tolerated through Day 14 20 more volunteers are enrolled at the 300 microgram dose 10 receiving vaccine administered by needle and syringe 10 receiving vaccine administered by Biojector If the 300 microgram dose appears safe and well tolerated through Day 14 in the 10 volunteers who receive intramuscular IM injections with needle and syringe an additional group of volunteers are enrolled at the 1000 microgram dose given with needle and syringe NOTE Within each group of 10 volunteers 8 receive APL-400-047 2 receive control preparation bupivacaine carrier alone AS PER AMENDMENT 0798 An additional group of 12 volunteers will be treated at a dose of 3000 micrograms administered by needle and syringe Ten of these volunteers will receive APL-400-047 formulated with bupivacaine as a facilitating agent the remaining 2 patients will receive control preparation bupivacaine carrier alone AS PER AMENDMENT 42799 Volunteers previously primed with either 300 or 1000 micrograms of the APL-400-047 vaccine receive an additional dose of DNA or control for control volunteers in the original protocol followed one month later by two monthly canarypox or placebo for control volunteers in the original protocol boosts
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