Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056745
Status:
COMPLETED
Last Update Posted:
2007-09-18
First Post:
2003-03-21
Brief Title:
Determining an Effective Site Groin Versus Arm for Giving HIV Vaccines
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
The Role of Immunization Site in Eliciting Mucosal Immunity
Status:
COMPLETED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 and immune system response to the TBC-3B HIV vaccine when it is injected either into the groin area or into the arm The goal is to determine which injection site is better at producing a particular type of immune response This study is not evaluating the effectiveness of the vaccine so volunteers must maintain low risk behavior for HIV transmission throughout the study
Detailed Description:
The goal of this vaccination study is to evaluate the safety and immunogenicity of the Therion Biologic Corporation Cambridge MA TBC-3B vaccine TBC-3B consists of live recombinant vaccinia virus expressing the env and gagpol genes of HIV-1 strain IIIB TBC-3B will be administered by subcutaneous injection in the groin and in the deltoid region with the aim of determining which site is better at inducing mucosal immune responses Because the groin area drains to the inguinal lymph nodes vaccines given there may stimulate local immunologic activity in the draining rectal mucosa as well as systemic immunologic activity in the blood
Volunteers will be followed for 20 months The first 2 months of the study will be an evaluation of volunteers normal immune function Volunteers will then be randomly selected to receive the TBC-3B experimental HIV vaccine in either the groin area or in the deltoid region Neither volunteers nor study personnel will know which group the volunteer will be in until the day of the first immunization All volunteers will receive TBC-3B
During the 20 months of the study volunteers will be asked to donate blood up to 14 times undergo seven flexible sigmoidoscopies with biopsies and receive three pairs of vaccine injections For up to 36 days after each experimental vaccination volunteers will be asked to abstain from activity that might spread the virus in the vaccine and put others at risk Volunteers will receive specific instructions on how to avoid these risks Volunteers will also be asked not to engage in receptive anal intercourse during the study
Volunteers will be followed for 20 months The first 2 months of the study will be an evaluation of volunteers normal immune function Volunteers will then be randomly selected to receive the TBC-3B experimental HIV vaccine in either the groin area or in the deltoid region Neither volunteers nor study personnel will know which group the volunteer will be in until the day of the first immunization All volunteers will receive TBC-3B
During the 20 months of the study volunteers will be asked to donate blood up to 14 times undergo seven flexible sigmoidoscopies with biopsies and receive three pairs of vaccine injections For up to 36 days after each experimental vaccination volunteers will be asked to abstain from activity that might spread the virus in the vaccine and put others at risk Volunteers will receive specific instructions on how to avoid these risks Volunteers will also be asked not to engage in receptive anal intercourse during the study
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 |
|---|---|---|---|
| R01AI050467 | NIH | None | httpsreporternihgovquickSearchR01AI050467 |
| UCLA MIG-001 | None | None | None |