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Sponsored by: |
St. Jude Children's Research Hospital |
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Information provided by: | St. Jude Children's Research Hospital |
ClinicalTrials.gov Identifier: | NCT00187044 |
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.
Condition | Intervention | Phase |
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HIV Infection Human Immunodeficiency Virus |
Biological: PolyEnv1 vaccine |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Evaluation of the Safety of a Polyvalent Vaccinia Virus-HIV-1 Envelope Recombinant Vaccine (PolyEnv1) in Healthy Adults |
Enrollment: | 18 |
Study Start Date: | October 1997 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 |
Biological: PolyEnv1 vaccine
administered subcutaneously as 10*7 pfu in 0.8 mL
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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 person's 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 (i.e. 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Fewer than 3 of the following:
Current cigarette smoker History of high cholesterol History of diabetes or high blood sugar High blood pressure Heart disease before age 50 in parent or sibling Vaccinia virus seronegative
Exclusion Criteria:
United States, Tennessee | |
St. Jude Children's Research Hospital | |
Memphis, Tennessee, United States, 38105 |
Principal Investigator: | Pat Flynn, M.D. | St. Jude Children's Research Hospital |
Responsible Party: | St. Jude Children's Research Hospital ( Patricia Flynn, M.D., Principal Investigator ) |
Study ID Numbers: | DID955, PolyEnv1; IND 7097 |
Study First Received: | September 12, 2005 |
Last Updated: | June 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00187044 |
Health Authority: | United States: Food and Drug Administration |
Vaccine Prevention HIV AIDS |
Virus Diseases Sexually Transmitted Diseases, Viral Vaccinia HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Healthy Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |