A Phase 1 interventional study of EnvDNA, PolyEnv1, EnvPro in HIV Infections, sponsored by St. Jude Children's Research Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-26.
Sponsored by St. Jude Children's Research Hospital · Phase 1, Interventional, and Prevention
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.
4,342 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 3 is below the median of 83 across 3,312 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →St. Jude Children's Research Hospital is the lead sponsor of 439 studies on the registry; 101 are open to participants now.
Of its 61 completed or terminated interventional studies of FDA-regulated products, 37 (61%) have results posted.
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Normal laboratory values within 60 days prior to immunization defined as:
Fewer than 3 of the following:
Exclusion Criteria:
Biological: EnvDNA, PolyEnv1, EnvPro
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.
To evaluate the tolerability and safety of the multi-envelope vaccine regimen.
Time frame: 1 year
To characterize the kinetics, duration and magnitude of the HIV-envelope specific immune responses elicited by the multi-envelope vaccine regimen.
Time frame: 1 year
The record gives a start of May 2007, a primary completion of Jan 2008 and a completion of Jan 2008. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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