Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000958
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Placebo-Controlled Phase I Pilot Clinical Trial to Evaluate the Safety and Immunogenicity of ENV 2-3 a Yeast-Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1 in Combination With MTP-PEMF59 in Individuals With HIV Infection Placebo Patients Receive MF59 Emulsion Only
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Placebo-Controlled Phase I Pilot Clinical Trial to Evaluate the Safety and Immunogenicity of ENV 2-3 a Yeast-Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1 in Combination With MTP-PEMF59 in Individuals With HIV Infection Placebo Patients Receive MF59 Emulsion Only
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:
To determine the safety and immunogenicity of Env 2-3 in combination with MTP-PEMF59 adjuvant in adult volunteers with HIV infection
By vaccinating those who have HIV infection perhaps the replication reproduction of existing viral strains can be suppressed and the asymptomatic period early in the infectious process can be prolonged One potential way to do this is to boost HIV antigen-specific CD4 responses which may in turn increase the effectiveness of CD8 killing of HIV infected cells
By vaccinating those who have HIV infection perhaps the replication reproduction of existing viral strains can be suppressed and the asymptomatic period early in the infectious process can be prolonged One potential way to do this is to boost HIV antigen-specific CD4 responses which may in turn increase the effectiveness of CD8 killing of HIV infected cells
Detailed Description:
By vaccinating those who have HIV infection perhaps the replication reproduction of existing viral strains can be suppressed and the asymptomatic period early in the infectious process can be prolonged One potential way to do this is to boost HIV antigen-specific CD4 responses which may in turn increase the effectiveness of CD8 killing of HIV infected cells
Eight patients are entered in the pilot portion of the study thirty patients are entered on Part A and fifteen patients are entered on Part B In the pilot study patients receive 30 mcg Env 2-3 vaccine plus 0 - 10 mcg MTP-PEMF59 adjuvant Patients on Part A receive one of the following MF59 emulsion only 100 mcg MTP-PEMF59 only 30 mcg Env 2-3 with MF59 emulsion only or 30 mcg Env 2-3 vaccine with 100 mcg MTP-PEMF59 Patients on Part B receive either 100 mcg MTP-PEMF59 only or 30 mcg Env 2-3 vaccine plus 100 mcg MTP-PEMF59 Treatment is administered on days 0 28 and 112 and patients are followed for up to 10 months Per amendment patients may receive two additional doses of 30 mcg Env 2-3 or placebo in MTP-PEMF59 at 7 and 10 months Parts A and B or 9 and 12 months Pilot study after their initial inoculation
Eight patients are entered in the pilot portion of the study thirty patients are entered on Part A and fifteen patients are entered on Part B In the pilot study patients receive 30 mcg Env 2-3 vaccine plus 0 - 10 mcg MTP-PEMF59 adjuvant Patients on Part A receive one of the following MF59 emulsion only 100 mcg MTP-PEMF59 only 30 mcg Env 2-3 with MF59 emulsion only or 30 mcg Env 2-3 vaccine with 100 mcg MTP-PEMF59 Patients on Part B receive either 100 mcg MTP-PEMF59 only or 30 mcg Env 2-3 vaccine plus 100 mcg MTP-PEMF59 Treatment is administered on days 0 28 and 112 and patients are followed for up to 10 months Per amendment patients may receive two additional doses of 30 mcg Env 2-3 or placebo in MTP-PEMF59 at 7 and 10 months Parts A and B or 9 and 12 months Pilot study after their initial inoculation
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 |
|---|---|---|---|
| AVEG 103B | Registry Identifier | DAIDS ES Registry Number | None |
| 11546 | REGISTRY | None | None |
| AVEG 103A | None | None | None |