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Vaccines have been very successful in preventing viral infections such as hepatitis B and the measles. Viral vaccines work by causing a person's immune system to make cells that will work against the virus. Due to the success in treating other viral infections, scientists are trying to develop a vaccine for human immunodeficiency virus (HIV). HIV infection is the cause of acquired immune deficiency syndrome (AIDS). AIDS is one of the most serious viral infections we know.
This is a research study to evaluate the safety of a possible vaccine against HIV. Researchers want to determine that a person's immune system can respond to the HIV before he or she is exposed to it. Therefore that person may be able to be protected from infection with HIV.
This is a research study to find out about the safety of a new potential vaccine regimen against HIV. This potential vaccine regimen consists of a sequence of six vaccine shots that are being studied to see if they can help to protect people from the human immunodeficiency virus (HIV). HIV infection is the cause of AIDS. AIDS is one of the most serious viral infections we know. Twenty million people around the world have already died of AIDS and over 40 million people are currently infected with the virus. This study is being done to help us find an HIV vaccine that works.
Vaccines have been very successful in preventing 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. If a person's immune system can respond to HIV before he or she is exposed to it, that person may be able to be protected from infection with HIV.
The vaccine regimen that will be tested in this study is based on 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 all parts of the vaccine regimen in test tubes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EnvDNA, PolyEnv1, EnvPro | Biological | Description: The vaccine regimen is a series of 6 injections given 28 days apart. EnvDNA is administered intramuscularly as 100 mcg of recombinant DNA in 1.5 mL of PBS as injections #1, 2 and 5. PolyEnv1 is recombinant vaccinia virus administered subcutaneously as 107 pfu in 0.8 mL of PBS as injection #3. EnvPro is administered intramuscularly as 100 mcg of recombinant protein and 500 mcg of aluminum hydroxide (alum) adjuvant in 1.0 mL of PBS as injections #4 and 6. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the tolerability and safety of the multi-envelope vaccine regimen. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the kinetics, duration and magnitude of the HIV-envelope specific immune responses elicited by the multi-envelope vaccine regimen. | 1 year |
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Inclusion Criteria:
Healthy adults; age > 18 years, born after 1972 if born in U.S.
Informed consent
Normal history and physical exam
HIV-1 negative as documented by ELISA and Western blot analysis within 30 days prior to immunization
Normal laboratory values within 60 days prior to immunization defined as:
Normal CPK-MB (creatine kinase isoenzyme MB) and troponin I within 30 days prior to immunization
Normal ECG within 30 days prior to immunization
No evidence of smallpox vaccination (born in the U.S. after 1972 with no typical scar on the deltoid, ankle, thigh or between the scapulae and no history of vaccination in personal immunization record)
No entry into military service before 1990
Fewer than 3 of the following:
Not planning to become pregnant during study vaccinations and for 3 months after last vaccination
Vaccinia virus seronegative
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pat Flynn, MD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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|
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |