Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187148
Status:
COMPLETED
Last Update Posted:
2017-04-26
First Post:
2005-09-12
Brief Title:
Evaluate Tolerability of a Recombinant DNA HIV-1 Vaccine in Healthy Adults
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
Evaluation of the Tolerability and Safety of a Recombinant HIV-1 Multi-Envelope DNA Plasmid Vaccine EnvDNA in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2011-06
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:
This protocol will evaluate the safety and tolerability of the vaccine EnvDNA in healthy adults DNA-based vaccines are being studied for the prevention of human immunodeficiency virus HIV malaria and hepatitis DNA vaccines have been well tolerated in human studies to date The vaccine that will be tested in this study was made from the information that the virus uses to make a small part of the HIV This small part is called the envelope or coating around the virus We hope the body will make an immune response against the HIV envelope coat Our potential HIV DNA envelope vaccine is called EnvDNA
Detailed Description:
This is a research investigational study to find out about the safety of a new potential vaccine for HIV This potential vaccine may eventually become a part of a sequence of three experimental vaccines that will be studied to see if they can help to protect people from HIV HIV infection is the cause of AIDS Acquired Immune Deficiency Syndrome AIDS is one of the most serious viral infections we know This study is being done to help us find an HIV vaccine that works
The vaccine that will be tested in this study was made from the information that the virus uses to make a small part of the HIV This small part is called the envelope or coating around the virus Because only the information for this one part of the virus is used in the vaccine the vaccine cannot cause HIV infection We make the vaccine in a test tube The vaccine is made up of DNA DNA is like an instruction manual that cells use to make basic building blocks called proteins This DNA has the information that cells will use to make the envelope coat of HIV Once the DNA is injected intramuscularly it should tell cells to make the envelope protein We hope the body will make an immune response against the HIV envelope coat Our potential HIV DNA envelope vaccine is called EnvDNA
The vaccine that will be tested in this study was made from the information that the virus uses to make a small part of the HIV This small part is called the envelope or coating around the virus Because only the information for this one part of the virus is used in the vaccine the vaccine cannot cause HIV infection We make the vaccine in a test tube The vaccine is made up of DNA DNA is like an instruction manual that cells use to make basic building blocks called proteins This DNA has the information that cells will use to make the envelope coat of HIV Once the DNA is injected intramuscularly it should tell cells to make the envelope protein We hope the body will make an immune response against the HIV envelope coat Our potential HIV DNA envelope vaccine is called EnvDNA
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 |
|---|---|---|---|
| IND11130 | None | None | None |