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About
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.
Full 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.
Enrollment
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Inclusion criteria
Healthy adults; age greater than 18 years, less than or equal to 40 years
HIV-1 negative as documented by negative ELISA and negative Western blot analysis within 30 days prior to immunization
Normal history and physical exam
Normal complete blood count and differential obtained within 60 days prior to immunization, and defined as:
Anti-nuclear antibody titer <1:80 (by IFA) and negative anti-DNA antibody within 60 days prior to immunization
Negative for Hepatitis B surface antigen and Hepatitis C
AST and ALT within normal institutional limits obtained within 60 days prior to immunization
Serum creatinine, Na+, K+ and Cl- within normal institutional limits, obtained within 60 days prior to immunization
Serum creatine phosphokinase (CPK) within normal institutional limits obtained within 60 days prior to immunization
Not planning to become pregnant during study vaccinations and for three months after last vaccination
Availability for at least one year of follow-up
Exclusion criteria
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6 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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