Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000884
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Randomized Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 Delivered by Alternate Mucosal Routes 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 Randomized Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 Delivered by Alternate Mucosal Routes 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:
To compare the safety of ALVAC-HIV vCP205 to that of ALVAC-RG vCP65 rabies glycoprotein delivered by a variety of mucosal routes To evaluate the antibody humoral and cellular immune responses resulting from ALVAC-HIV vCP205 AS PER AMENDMENT 8398 To obtain safety data on AIDSVAX BB boosting administered by the intramuscular and intranasal routes in the context of previous immunization via alternate mucosal routes or intramuscularly with a canarypox vector expressing HIV-1 antigens vCP205 To obtain immunogenicity data on AIDSVAX BB boosting One of the earliest observations in the HIV epidemic was the demonstration of HIV infection at mucosal surfaces of cells in the genital tract These data suggest that priming of immune defenses of viral infected cells may be an important component in the strategy of developing an effective HIV vaccine Direct immunization of relevant mucosal surfaces with a vectored vaccine may stimulate mucosal immunity The ALVAC-HIV vCP205 immunogen is constructed from a live recombinant canarypox vector that has a good safety profile in volunteers and should allow mucosal induction of immunity
Detailed Description:
One of the earliest observations in the HIV epidemic was the demonstration of HIV infection at mucosal surfaces of cells in the genital tract These data suggest that priming of immune defenses of viral infected cells may be an important component in the strategy of developing an effective HIV vaccine Direct immunization of relevant mucosal surfaces with a vectored vaccine may stimulate mucosal immunity The ALVAC-HIV vCP205 immunogen is constructed from a live recombinant canarypox vector that has a good safety profile in volunteers and should allow mucosal induction of immunity
This randomized double-blind trial evaluates the safety of and immune response to vaccination with ALVAC-HIV vCP205 given at 0 1 3 and 6 months Patients are randomly assigned to 1 of 7 drug administration routes as follows
Group A Intramuscular Group B Oral Group C Intranasal Group D Intrarectal Group E Intravaginal Group F Intranasalintramuscular Group G Intrarectalintramuscular Twelve patients are randomized to each group 8 of whom receive experimental therapy with ALVAC-HIV vCP205 and 4 of whom receive control therapy with ALVAC-RG vCP2058 rabies vaccine Women are preferentially enrolled with a goal of 60 women minimum of 4 women per treatment arm only women are randomized to Group E Blinding is maintained with respect to drug assignment rather than route of administration after randomization NOTE The protocol will be amended to add 2 boost vaccinations with subunit products at approximately Months 9 and 12 when a suitable boost product is identified AS PER AMENDMENT 8398 The protocol has been modified to include 2 booster vaccinations to be administered at 9 and 12 months Patients in Group A receive booster vaccination with ALVAC-HIV VCP205 or ALVAC-RG intranasally Patients in Groups B through G are boosted with AIDSVAX BB vaccine a bivalent vaccine consisting of MN rgp120HIV-1 antigen and GNE8 rgp120HIV-1 antigen in alum adjuvant or with Imovax diploid cell rabies vaccine vaccinations for these patients are given intramuscularly AS PER AMENDMENT 111998 The second booster vaccination for group A will be administered at study Month 15
This randomized double-blind trial evaluates the safety of and immune response to vaccination with ALVAC-HIV vCP205 given at 0 1 3 and 6 months Patients are randomly assigned to 1 of 7 drug administration routes as follows
Group A Intramuscular Group B Oral Group C Intranasal Group D Intrarectal Group E Intravaginal Group F Intranasalintramuscular Group G Intrarectalintramuscular Twelve patients are randomized to each group 8 of whom receive experimental therapy with ALVAC-HIV vCP205 and 4 of whom receive control therapy with ALVAC-RG vCP2058 rabies vaccine Women are preferentially enrolled with a goal of 60 women minimum of 4 women per treatment arm only women are randomized to Group E Blinding is maintained with respect to drug assignment rather than route of administration after randomization NOTE The protocol will be amended to add 2 boost vaccinations with subunit products at approximately Months 9 and 12 when a suitable boost product is identified AS PER AMENDMENT 8398 The protocol has been modified to include 2 booster vaccinations to be administered at 9 and 12 months Patients in Group A receive booster vaccination with ALVAC-HIV VCP205 or ALVAC-RG intranasally Patients in Groups B through G are boosted with AIDSVAX BB vaccine a bivalent vaccine consisting of MN rgp120HIV-1 antigen and GNE8 rgp120HIV-1 antigen in alum adjuvant or with Imovax diploid cell rabies vaccine vaccinations for these patients are given intramuscularly AS PER AMENDMENT 111998 The second booster vaccination for group A will be administered at study Month 15
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 |
|---|---|---|---|
| 10577 | REGISTRY | DAIDS ES Registry Number | None |