Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076063
Status:
COMPLETED
Last Update Posted:
2021-10-14
First Post:
2004-01-13
Brief Title:
A Study of LIPO-5 and ALVAC-HIV vCP1452 as Possible HIV Vaccines
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Clinical Trial to Evaluate the Safety and Immunogenicity of LIPO-5 Alone ALVAC-HIV vCP1452 Alone and ALVAC PrimeLIPO-5 Boost in Healthy HIV-1 Uninfected Adult Participants
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:
This study will test the immune system response to and safety of two HIV vaccines alone and in combination ALVAC-HIV vCP1452 and LIPO-5 ALVAC-HIV vCP1452 uses a canarypox virus with man-made parts of HIV attached to it The canarypox virus cannot cause disease in people LIPO-5 is a mixture of five man-made proteins similar to proteins found in HIV
These vaccines are not produced from live HIV or from infected cells and do not contain the virus It is not possible to become infected with HIV from these vaccines
These vaccines are not produced from live HIV or from infected cells and do not contain the virus It is not possible to become infected with HIV from these vaccines
Detailed Description:
Immune priming of cytotoxic T lymphocytes CTLs has been most successfully achieved with live attenuated virus or live virus vector vaccines Recombinant canarypox vaccines have an excellent safety record and have induced HIV neutralizing antibodies and CTLs in early clinical trials This study will evaluate the use of HIV lipopeptides LIPO-5 alone and in combination with a canarypox-based HIV vaccine ALVAC-HIV vCP1452 to further increase CTL activity
Participants in this study will be randomly assigned to one of five groups Participants in Groups A and B will receive four injections over 6 months Participants in Group A will receive four injections of either LIPO-5 or a placebo Participants in Group B will receive four injections of either the ALVAC-HIV vCP1452 or a placebo Participants in Groups C D and E will receive six injections over 6 months Participants in these groups will receive either ALVAC-HIV vCP1452 and LIPO-5 or a placebo Participants who receive the vaccine combination will receive four injections of the same dose of ALVAC-HIV vCP1452 and two injections of LIPO-5 The dose of LIPO-5 will be different for participants in Groups C D and E
Participants will have 11 study visits over 18 months the total duration of the study will be 30 months The length of visits will vary and may last up to 3 hours Study visits will include a medical interview brief physical exam and blood and urine tests Participants will be tested for HIV before entering the study and at least five times during the study All vaccine and placebo injections will be given in the upper arm muscle
Participants in this study will be randomly assigned to one of five groups Participants in Groups A and B will receive four injections over 6 months Participants in Group A will receive four injections of either LIPO-5 or a placebo Participants in Group B will receive four injections of either the ALVAC-HIV vCP1452 or a placebo Participants in Groups C D and E will receive six injections over 6 months Participants in these groups will receive either ALVAC-HIV vCP1452 and LIPO-5 or a placebo Participants who receive the vaccine combination will receive four injections of the same dose of ALVAC-HIV vCP1452 and two injections of LIPO-5 The dose of LIPO-5 will be different for participants in Groups C D and E
Participants will have 11 study visits over 18 months the total duration of the study will be 30 months The length of visits will vary and may last up to 3 hours Study visits will include a medical interview brief physical exam and blood and urine tests Participants will be tested for HIV before entering the study and at least five times during the study All vaccine and placebo injections will be given in the upper arm muscle
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 |
|---|---|---|---|
| 10119 | REGISTRY | DAIDS ES Registry Number | None |
| ANRS VAC019 | None | None | None |