Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011037
Status:
COMPLETED
Last Update Posted:
2021-10-14
First Post:
2001-02-08
Brief Title:
ALVAC-HIV vCP1452 Alone and Combined With MN rgp120
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Multisite Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of ALVAC-HIV vCP1452 Alone and Combined With MN rgp120
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:
The purpose of this study is to test how the bodys immune system responds to the vaccine ALVAC-HIV vCP1452 and to determine if the vaccine is safe when given alone and with MN rgp120
HIV infection and AIDS have no cure in spite of recent advances in anti-HIV drugs Many worldwide populations cannot afford the antiviral treatments for infected people HIV vaccines offer hope for disease prevention In this trial 2 experimental HIV vaccines called ALVAC vCP1452 and MN rgp120 will be given to volunteers in Haiti Brazil Peru and Trinidad and Tobago The study will determine how volunteers immune systems respond to the vaccines This protocol has been changed by adding new international sites
HIV infection and AIDS have no cure in spite of recent advances in anti-HIV drugs Many worldwide populations cannot afford the antiviral treatments for infected people HIV vaccines offer hope for disease prevention In this trial 2 experimental HIV vaccines called ALVAC vCP1452 and MN rgp120 will be given to volunteers in Haiti Brazil Peru and Trinidad and Tobago The study will determine how volunteers immune systems respond to the vaccines This protocol has been changed by adding new international sites
Detailed Description:
There is no cure for HIV infection or AIDS in spite of recent advances in antiviral therapy Furthermore drug therapy is too expensive for most affected populations For this reason there is a commitment to the development of safe effective vaccines to prevent HIV infection and AIDS worldwide This study evaluates the immunogenicity and safety of candidate HIV-1 vaccines based on the canarypox vector termed ALVAC alone and combined with an MN rgp120 product at 3 AS PER AMENDMENT 71901 5 international sites
AS PER AMENDMENT 71901 Volunteers in Rio de Janeiro Haiti and Trinidad and Tobago comprise Part I volunteers in Sao Paulo and Peru comprise Part II Volunteers from Haiti Brazil AS PER AMENDMENT 71901 Peru and Trinidad and Tobago are enrolled into 1 of 3 arms and followed for 18 months Arm 1 volunteers receive ALVAC-HIV vCP1452 at 0 1 3 and 6 months Arm 2 volunteers receive ALVAC-HIV vCP1452 on the same schedule as Arm 1 and receive HIV-1 MN rgp120 subunit simultaneously with the 3-month and 6-month vaccine doses Arm 3 volunteers receive a placebo Blood and urine samples are collected for immunologic assays virologic determinations pregnancy testing and safety assessments Risk behavior and social harms are assessed every 6 months during follow-up AS PER AMENDMENT 71901 Social harms are assessed every 3 months during follow-up and risk behavior every 6 months At all clinic visits volunteers receive counseling on avoidance of HIV infection and pregnancy Participants are tested for HIV-1 every 3 AS PER AMENDMENT 71901 the following text has been deleted to 6 months Counseling and follow-up for any needed medical care are provided
AS PER AMENDMENT 71901 Volunteers in Rio de Janeiro Haiti and Trinidad and Tobago comprise Part I volunteers in Sao Paulo and Peru comprise Part II Volunteers from Haiti Brazil AS PER AMENDMENT 71901 Peru and Trinidad and Tobago are enrolled into 1 of 3 arms and followed for 18 months Arm 1 volunteers receive ALVAC-HIV vCP1452 at 0 1 3 and 6 months Arm 2 volunteers receive ALVAC-HIV vCP1452 on the same schedule as Arm 1 and receive HIV-1 MN rgp120 subunit simultaneously with the 3-month and 6-month vaccine doses Arm 3 volunteers receive a placebo Blood and urine samples are collected for immunologic assays virologic determinations pregnancy testing and safety assessments Risk behavior and social harms are assessed every 6 months during follow-up AS PER AMENDMENT 71901 Social harms are assessed every 3 months during follow-up and risk behavior every 6 months At all clinic visits volunteers receive counseling on avoidance of HIV infection and pregnancy Participants are tested for HIV-1 every 3 AS PER AMENDMENT 71901 the following text has been deleted to 6 months Counseling and follow-up for any needed medical care are provided
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 |
|---|---|---|---|
| HIVNET 026 | Registry Identifier | DAIDS ES Registry Number | None |
| 10529 | REGISTRY | None | None |