Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001090
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
A Multicenter Randomized Placebo-Controlled Double-Blinded Phase I Trial to Evaluate the Safety and Immunogenicity of Live Recombinant Canarypox ALVAC-HIV vCP205 Combined With GM-CSF in Healthy HIV-1 Uninfected Volunteers
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Multicenter Randomized Placebo-Controlled Double-Blinded Phase I Trial to Evaluate the Safety and Immunogenicity of Live Recombinant Canarypox ALVAC-HIV vCP205 Combined With Granulocyte-Macrophage Colony Stimulating Factor GM-CSF in Healthy HIV-1 Uninfected 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:
To evaluate the safety and immunogenicity of live recombinant canarypox ALVAC-HIV vCP205 in combination with recombinant human granulocyte-macrophage colony-stimulating factor GM-CSF at 80 microg and 250 microg AS PER AMENDMENT 43099 To study the safety of following 4 ALVAC immunizations with a nucleic acid gagpol HIV-1 immunogen APL-400-047 Wyeth-Lederle To assess the ability of this sequence of immunization to boost the LTL T-helper cell and antibody response ALVAC-HIV candidate vaccines have induced HIV-specific CTL responses in more than half of recipients in some protocols Depending on the HIV-1 gene products expressed by the particular ALVAC-HIV candidate vaccine volunteers have generated anti-Envelope vCP125 vCP205 and vCP300 anti-Gag vCP205 and vCP300 and anti-Nef vCP300 CTL activity Although 3 to 4 immunizations with the different ALVAC-HIV experimental vaccines induce anti-HIV-1 neutralizing antibodies in a portion often the majority of volunteers the geometric mean titers of these antibodies are modest usually less than 50 This study will determine whether there is an increase in the anti-HIV antibody titers when GM-CSF is used as an adjuvant with ALVAC-HIV vCP205 and will also examine the kinetics and magnitude of the HIV-specific CTL response
Detailed Description:
ALVAC-HIV candidate vaccines have induced HIV-specific CTL responses in more than half of recipients in some protocols Depending on the HIV-1 gene products expressed by the particular ALVAC-HIV candidate vaccine volunteers have generated anti-Envelope vCP125 vCP205 and vCP300 anti-Gag vCP205 and vCP300 and anti-Nef vCP300 CTL activity Although 3 to 4 immunizations with the different ALVAC-HIV experimental vaccines induce anti-HIV-1 neutralizing antibodies in a portion often the majority of volunteers the geometric mean titers of these antibodies are modest usually less than 50 This study will determine whether there is an increase in the anti-HIV antibody titers when GM-CSF is used as an adjuvant with ALVAC-HIV vCP205 and will also examine the kinetics and magnitude of the HIV-specific CTL response
In this randomized placebo-controlled double-blinded study volunteers receive ALVAC-HIV vCP205 at 1063 TCID50 or placebo and GM-CSF or placebo by intramuscular injection at Months 0 1 3 and 6 as follows
Group A vCP205 plus GM-CSF placebo 10 volunteers Group B vCP205 plus 80 microg GM-CSF 10 volunteers Group C vCP205 plus 250 microg GM-CSF 10 volunteers Group D vcP205 placebo plus GM-CSF placebo 6 volunteers AS PER AMENDMENT 043099 Boosting with APL-400-047 HIV-1 gagpol DNA is added for volunteers who have received all scheduled immunization in the original protocol Volunteers in Groups A B and C will receive booster intramuscular injections of DNA vaccine at Months 0 and 1 those in Group D will receive DNA control bupivacaine carrier alone at Months 0 and 1
In this randomized placebo-controlled double-blinded study volunteers receive ALVAC-HIV vCP205 at 1063 TCID50 or placebo and GM-CSF or placebo by intramuscular injection at Months 0 1 3 and 6 as follows
Group A vCP205 plus GM-CSF placebo 10 volunteers Group B vCP205 plus 80 microg GM-CSF 10 volunteers Group C vCP205 plus 250 microg GM-CSF 10 volunteers Group D vcP205 placebo plus GM-CSF placebo 6 volunteers AS PER AMENDMENT 043099 Boosting with APL-400-047 HIV-1 gagpol DNA is added for volunteers who have received all scheduled immunization in the original protocol Volunteers in Groups A B and C will receive booster intramuscular injections of DNA vaccine at Months 0 and 1 those in Group D will receive DNA control bupivacaine carrier alone at Months 0 and 1
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 |
|---|---|---|---|
| 10582 | REGISTRY | DAIDS ES Registry Number | None |