Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187044
Status:
COMPLETED
Last Update Posted:
2011-09-29
First Post:
2005-09-12
Brief Title:
Evaluation of the Safety of a Polyvalent Virus in Healthy Adults
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
Evaluation of the Safety of a Polyvalent Vaccinia Virus-HIV-1 Envelope Recombinant Vaccine PolyEnv1 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 is a research study to evaluate the safety of a vaccine to protect people from HIV infection Human Immunodeficiency Virus HIV is the cause of AIDS Acquired Immune Deficiency Syndrome AIDS is one of the most serious viral infections of our time It is believed that all persons who contract HIV will eventually develop AIDS Because of this we are trying to develop new ways to prevent infection with HIV
The vaccine that will be tested in this study has been prepared from a small part of the HIV The part of the HIV used in this vaccine is the envelope or coating part of the virus In this study researchers will evaluate how well the vaccine is tolerated how much vaccine should be given and determine if any side effects occur in response to the vaccination
The vaccine that will be tested in this study has been prepared from a small part of the HIV The part of the HIV used in this vaccine is the envelope or coating part of the virus In this study researchers will evaluate how well the vaccine is tolerated how much vaccine should be given and determine if any side effects occur in response to the vaccination
Detailed Description:
This is a research study to evaluate the safety of a vaccine to protect people from HIV infection Human Immunodeficiency Virus HIV is the cause of AIDS Acquired Immune Deficiency Syndrome AIDS is one of the most serious viral infections of our time It is believed that all persons who contract HIV will eventually develop AIDS Because of this we are trying to develop new ways to prevent infection with HIV
Vaccines have been very successful in preventing or decreasing the symptoms of a number of other viral infections such as hepatitis B polio and measles Viral vaccines work by causing a persons immune system to make antibodies and immune cells against the virus or to respond to the virus Because of the success with other viral infections scientists are trying to develop a successful vaccine for HIV
The vaccine that will be tested in this study has been prepared from a small part of the HIV The part of the HIV used in this vaccine is the envelope or coating part of the virus Because only this one part of the virus is used in the vaccine the vaccine cannot cause HIV infection The envelope part of HIV has been put into another virus the vaccinia virus The vaccinia virus has been used as a vaccine for many decades in millions of people and is the vaccine that eliminated the disease known as smallpox ie smallpox vaccine The smallpox vaccine is a licensed and effective vaccine Making a new vaccine by putting part of a different virus into the smallpox vaccine also known as vaccinia virus is called a recombinant vaccinia virus vaccine Our new recombinant vaccine product is called PolyEnv1 In this study researchers will evaluate how well the vaccine is tolerated how much vaccine should be given and determine if any side effects occur in response to the vaccination
Vaccines have been very successful in preventing or decreasing the symptoms of a number of other viral infections such as hepatitis B polio and measles Viral vaccines work by causing a persons immune system to make antibodies and immune cells against the virus or to respond to the virus Because of the success with other viral infections scientists are trying to develop a successful vaccine for HIV
The vaccine that will be tested in this study has been prepared from a small part of the HIV The part of the HIV used in this vaccine is the envelope or coating part of the virus Because only this one part of the virus is used in the vaccine the vaccine cannot cause HIV infection The envelope part of HIV has been put into another virus the vaccinia virus The vaccinia virus has been used as a vaccine for many decades in millions of people and is the vaccine that eliminated the disease known as smallpox ie smallpox vaccine The smallpox vaccine is a licensed and effective vaccine Making a new vaccine by putting part of a different virus into the smallpox vaccine also known as vaccinia virus is called a recombinant vaccinia virus vaccine Our new recombinant vaccine product is called PolyEnv1 In this study researchers will evaluate how well the vaccine is tolerated how much vaccine should be given and determine if any side effects occur in response to the vaccination
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 |
|---|---|---|---|
| PolyEnv1 IND 7097 | None | None | None |