Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000813
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox-gp160 MN ALVAC vCP125 HIV-1 gp160 MN 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 Live Recombinant Canarypox-gp160 MN ALVAC vCP125 HIV-1 gp160 MN in HIV-1 Uninfected Adult Volunteers
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:
Part A To evaluate the safety and immunogenicity of ALVAC vCP125 HIV-1 gp160 MN live canarypox recombinant vaccine ALVAC gp160 MN versus a recombinant canarypox expressing the rabies glycoprotein ALVAC rabies glycoprotein as a control in healthy HIV-1 uninfected adult volunteers
Part B To evaluate the schedule of two immunizations with ALVAC gp160 MN for optimal immunogenicity
Amendment 122293 To determine whether ALVAC gp160 MN in combination with SF-2 rgp120 subunit protein is capable of generating humoral and cellular immune responses of greater intensity and longer duration than either vaccine administered alone
A canarypox-vectored vaccine ALVAC that expresses the gp160 antigen of the HIV-1 MN strain might satisfy many criteria for an affordable HIV vaccine Per 122293 amendment Cellular responses have been augmented by the combination of two recombinant vaccines especially in vaccinia naive individuals
Part B To evaluate the schedule of two immunizations with ALVAC gp160 MN for optimal immunogenicity
Amendment 122293 To determine whether ALVAC gp160 MN in combination with SF-2 rgp120 subunit protein is capable of generating humoral and cellular immune responses of greater intensity and longer duration than either vaccine administered alone
A canarypox-vectored vaccine ALVAC that expresses the gp160 antigen of the HIV-1 MN strain might satisfy many criteria for an affordable HIV vaccine Per 122293 amendment Cellular responses have been augmented by the combination of two recombinant vaccines especially in vaccinia naive individuals
Detailed Description:
A canarypox-vectored vaccine ALVAC that expresses the gp160 antigen of the HIV-1 MN strain might satisfy many criteria for an affordable HIV vaccine Per 122293 amendment Cellular responses have been augmented by the combination of two recombinant vaccines especially in vaccinia naive individuals
In Part A 28 healthy volunteers 15 vaccinia-immune and 13 vaccinia-naive are randomized to receive intramuscular injections of ALVAC gp160 MN at a dose of 1 million TCID50 or ALVAC rabies glycoprotein as a control at months 0 and 2 In Part B 90 healthy volunteers 60 vaccinia immune and 30 vaccinia naive are randomized to receive ALVAC gp160 MN at a dose of 10 million TCID50 or ALVAC rabies glycoprotein control on an immunization schedule of either month 0 and 1 or 0 and 2 For Part B half of the patients receiving ALVAC gp160 MN as well as approximately half of those receiving control vaccine will receive booster immunizations with SF-2 rgp120 subunit protein if available at months 9 and 12 the other half will receive booster immunizations with the same preparation as they received for their first two immunizations In Part A all control volunteers except one within each control group receive SF-2 rgp120 subunit protein at months 9 and 12 An additional group of 10 volunteers will receive four injections of SF-2 rgp120 subunit protein at months 0 1 6 and 12 Part B will begin whenever the higher dose of ALVAC gp160 MN becomes available at least 4 weeks after initiation of Part A Volunteers are followed for at least 18 months Per 061094 addendum volunteers will be contacted once or twice per year for at least 5 years to check on health status
In Part A 28 healthy volunteers 15 vaccinia-immune and 13 vaccinia-naive are randomized to receive intramuscular injections of ALVAC gp160 MN at a dose of 1 million TCID50 or ALVAC rabies glycoprotein as a control at months 0 and 2 In Part B 90 healthy volunteers 60 vaccinia immune and 30 vaccinia naive are randomized to receive ALVAC gp160 MN at a dose of 10 million TCID50 or ALVAC rabies glycoprotein control on an immunization schedule of either month 0 and 1 or 0 and 2 For Part B half of the patients receiving ALVAC gp160 MN as well as approximately half of those receiving control vaccine will receive booster immunizations with SF-2 rgp120 subunit protein if available at months 9 and 12 the other half will receive booster immunizations with the same preparation as they received for their first two immunizations In Part A all control volunteers except one within each control group receive SF-2 rgp120 subunit protein at months 9 and 12 An additional group of 10 volunteers will receive four injections of SF-2 rgp120 subunit protein at months 0 1 6 and 12 Part B will begin whenever the higher dose of ALVAC gp160 MN becomes available at least 4 weeks after initiation of Part A Volunteers are followed for at least 18 months Per 061094 addendum volunteers will be contacted once or twice per year for at least 5 years to check on health status
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10557 | REGISTRY | DAIDS ES Registry Number | None |
| AVEG 012B | None | None | None |