Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000633
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
1999-11-02
Brief Title:
A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals
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 Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals
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 vaccinia-derived HIV-1 recombinant envelope glycoprotein gp160 in asymptomatic HIV-infected adult volunteers To compare safety and immunogenicity of two different schedules of gp160 administration To examine the effects of gp160 and hepatitis B vaccine Engerix-B on various markers of viral load and on selected immune parameters
Potentiation of a patients immune response to HIV might possibly prolong the period of clinical latency and protect the patient indefinitely Preliminary results from a study of Immuno-AG recombinant gp160 vaccine in healthy volunteers not infected with HIV suggest that the vaccine is safe and produces antibodies against the virus Because another previous study failed to demonstrate a specific anti-HIV response in patients injected with a recombinant vaccinia virus containing HIV-1 genes this study is also testing the immunotherapeutic role of other immunizations such as hepatitis B vaccination that would be expected to induce a nonspecific immune response in HIV-infected persons
Potentiation of a patients immune response to HIV might possibly prolong the period of clinical latency and protect the patient indefinitely Preliminary results from a study of Immuno-AG recombinant gp160 vaccine in healthy volunteers not infected with HIV suggest that the vaccine is safe and produces antibodies against the virus Because another previous study failed to demonstrate a specific anti-HIV response in patients injected with a recombinant vaccinia virus containing HIV-1 genes this study is also testing the immunotherapeutic role of other immunizations such as hepatitis B vaccination that would be expected to induce a nonspecific immune response in HIV-infected persons
Detailed Description:
Potentiation of a patients immune response to HIV might possibly prolong the period of clinical latency and protect the patient indefinitely Preliminary results from a study of Immuno-AG recombinant gp160 vaccine in healthy volunteers not infected with HIV suggest that the vaccine is safe and produces antibodies against the virus Because another previous study failed to demonstrate a specific anti-HIV response in patients injected with a recombinant vaccinia virus containing HIV-1 genes this study is also testing the immunotherapeutic role of other immunizations such as hepatitis B vaccination that would be expected to induce a nonspecific immune response in HIV-infected persons
Fifty-five healthy HIV-positive volunteers are randomly assigned to one of the following treatment arms six injections arm I or four injections arm II of HIV-1 gp160 vaccine four injections of hepatitis B vaccine as a non-HIV viral vaccine control arm III or six placebo injections consisting of the adjuvant vehicle used for the gp160 vaccine arm IV Immunizations or placebo are given at 4-week intervals for 5 months To maintain blinding adjuvant vehicle placebo is administered on days 84 and 112 to those volunteers receiving four instead of six vaccine injections arms II and III Volunteers are followed at 4-month intervals for 2 years
Fifty-five healthy HIV-positive volunteers are randomly assigned to one of the following treatment arms six injections arm I or four injections arm II of HIV-1 gp160 vaccine four injections of hepatitis B vaccine as a non-HIV viral vaccine control arm III or six placebo injections consisting of the adjuvant vehicle used for the gp160 vaccine arm IV Immunizations or placebo are given at 4-week intervals for 5 months To maintain blinding adjuvant vehicle placebo is administered on days 84 and 112 to those volunteers receiving four instead of six vaccine injections arms II and III Volunteers are followed at 4-month intervals for 2 years
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 101 | Registry Identifier | DAIDS ES Registry Number | None |
| 11182 | REGISTRY | None | None |