Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00007423
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2000-12-19
Brief Title:
Safety and Effectiveness of the Vaccine ALVAC-HIV vCP205 in HIV-Negative Adult Volunteers in Uganda
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 Study of the Safety and Immunogenicity of Live Recombinant ALVAC-HIV vCP205 in HIV-1 Uninfected Adult Volunteers in Uganda
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 see if it is safe to give ALVAC-HIV vCP205 a possible HIV vaccine and to study the immune responses in adult HIV-1 uninfected volunteers
Uganda has been severely affected by HIV infection and AIDS and has been selected to participate in HIV-vaccine development The HIV viruses commonly isolated from Uganda are 2 kinds that are not used in making current vaccines Current vaccines generate several kinds of immune responses Researchers would like to see if a response to the kind of virus in a current vaccine will also protect people from the viruses commonly found in Uganda
Uganda has been severely affected by HIV infection and AIDS and has been selected to participate in HIV-vaccine development The HIV viruses commonly isolated from Uganda are 2 kinds that are not used in making current vaccines Current vaccines generate several kinds of immune responses Researchers would like to see if a response to the kind of virus in a current vaccine will also protect people from the viruses commonly found in Uganda
Detailed Description:
The African country of Uganda is severely affected by HIV infection and AIDS and has been selected by the World Health Organization to participate in HIV-vaccine development The predominant HIV-1 strains isolated from Ugandans are members of clade A and clade D The only vaccines available for human testing are based on envelope proteins from clade B and clade E viruses ALVAC-HIV vCP205 is a second generation vaccine that can induce a humoral and cellular response against several antigens The current study will attempt to extend these findings to determine if the vCP205 vaccine when administered to Ugandans can induce cytotoxic T-lymphocyte CTL responses that are reactive against the HIV strains prevalent in Uganda
Volunteers are randomized into 1 of 3 groups and receive either the candidate HIV-1 vaccine ALVAC-HIV vCP205 the experimental canarypox rabies vaccine ALVAC-RG or placebo-ALVAC Neither the volunteer nor hisher health care professional knows which preparation is being given Volunteers receive 4 injections over a period of 6 months and are followed for up to 24 months Clinical observations and monitoring of hematological chemical and immunologic parameters are done Safety is evaluated by monitoring for local and systemic adverse reactions during the course of the trial Comparative immunogenicity analyses are based on CTL responses to HIV and measures of binding and HIV-specific antibody responses At each visit volunteers are counseled on how to avoid HIV exposure and pregnancy
Volunteers are randomized into 1 of 3 groups and receive either the candidate HIV-1 vaccine ALVAC-HIV vCP205 the experimental canarypox rabies vaccine ALVAC-RG or placebo-ALVAC Neither the volunteer nor hisher health care professional knows which preparation is being given Volunteers receive 4 injections over a period of 6 months and are followed for up to 24 months Clinical observations and monitoring of hematological chemical and immunologic parameters are done Safety is evaluated by monitoring for local and systemic adverse reactions during the course of the trial Comparative immunogenicity analyses are based on CTL responses to HIV and measures of binding and HIV-specific antibody responses At each visit volunteers are counseled on how to avoid HIV exposure and pregnancy
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 |
|---|---|---|---|
| 10590 | REGISTRY | DAIDS ES Registry Number | None |