Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076817
Status:
COMPLETED
Last Update Posted:
2012-10-29
First Post:
2004-02-03
Brief Title:
Safety and Effectiveness of Administering an HIV Vaccine in the Groin Versus the Arm
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 Double Blind Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of the Aventis Pasteur ALVAC-HIV vCP205 Administered to the Groin Area Versus the Deltoid Area
Status:
COMPLETED
Status Verified Date:
2012-10
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 determine the safety of and immune system response to the ALVAC-HIV vCP205 vaccine when it is injected either into the groin area or into the arm The goal is to determine if injecting the vaccine into the groin area produces a better immune response in the lining of the rectum
Detailed Description:
HIV is most commonly transmitted via a mucosal surface The mucosal lining is a potential site of both humoral and cellular protection through the activity of B lymphocytes activated memory T lymphocytes secretory IgA and antigen presenting cells In addition to systemic immunity a preventive HIV vaccine should induce immune responses at the mucosal surfaces that are portals of HIV entry into the body
Targeted lymph node immunization involves vaccine injection into the subcutaneous tissue near a lymph node This strategy has proven effective in the simian immunodeficiency virus SIVrhesus macaque model The iliac and inguinal lymph nodes in the groin are the primary draining lymph nodes of the genitourinary and rectal tracts This study will evaluate and compare the safety and immunogenicity of ALVAC-HIV vCP205 when administered subcutaneously in the groin and intramuscularly in the deltoid region ALVAC-HIV vCP205 is a canarypox virus vector vaccine expressing portions of the gp120 Gag and Pol genes
Participants in this study will be randomly assigned to receive vaccine or placebo injections in the groin area or the upper arm All participants will have three baseline visits for blood tests and sigmoidoscopies to measure baseline immune functions After these visits participants will receive weekly injections for 4 weeks Groin injections will be given subcutaneously under the skin and upper arm injections will be given intramuscularly into the muscle Participants will have follow-up visits 5 and 11 months after the last immunization Participants will have blood draws and sigmoidoscopies and will receive HIV risk reduction counseling throughout the study Total length of participation will be approximately 14 months Participants may continue to contact the study for HIV testing and study-related concerns for 1 year after study participation
Targeted lymph node immunization involves vaccine injection into the subcutaneous tissue near a lymph node This strategy has proven effective in the simian immunodeficiency virus SIVrhesus macaque model The iliac and inguinal lymph nodes in the groin are the primary draining lymph nodes of the genitourinary and rectal tracts This study will evaluate and compare the safety and immunogenicity of ALVAC-HIV vCP205 when administered subcutaneously in the groin and intramuscularly in the deltoid region ALVAC-HIV vCP205 is a canarypox virus vector vaccine expressing portions of the gp120 Gag and Pol genes
Participants in this study will be randomly assigned to receive vaccine or placebo injections in the groin area or the upper arm All participants will have three baseline visits for blood tests and sigmoidoscopies to measure baseline immune functions After these visits participants will receive weekly injections for 4 weeks Groin injections will be given subcutaneously under the skin and upper arm injections will be given intramuscularly into the muscle Participants will have follow-up visits 5 and 11 months after the last immunization Participants will have blood draws and sigmoidoscopies and will receive HIV risk reduction counseling throughout the study Total length of participation will be approximately 14 months Participants may continue to contact the study for HIV testing and study-related concerns for 1 year after study participation
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 |
|---|---|---|---|
| 5R01AI050467-03 | NIH | None | httpsreporternihgovquickSearch5R01AI050467-03 |
| UCLA MIG-003 | None | None | None |