A5379 is a study looking at hepatitis B vaccination in adults living with HIV. Hepatitis B is a serious viral infection that affects the liver and is transmitted through blood and body fluids. The study will involve individuals who have received a previous hepatitis B vaccination but the vaccine did not respond well and individuals who have never received the vaccination. The study will take place both in the US and internationally. The study will compare how well an individual responds to the vaccine in different groups based on the type of vaccine and number of doses.More
- Living with HIV - Been on HIV treatment for more than 56 days - Previously received vaccines for hepatitis B, but the vaccines didn’t work - There will be a small group of participants (73) who have never been vaccinated for hepatitis B. - CD4 cell count (the number of white blood cells that fight infection) more than 100 - HIV viral load (how much HIV is in the body) less than 1000 - In the group vaccinated with a hepatitis B vaccine, the vaccination was over 168 days ago - No previous hepatitis B infection or exposure to hepatitis B infection
III/IV - A combination of phases: (3) Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants. and (4) Research Studies occurring after FDA has approved a drug for marketing. These studies gather additional information about a drug's safety, efficacy, or optimal use.
University of Colorado Hospital
Protocol Number: 19-2935
More information available at ClinicalTrials.gov: NCT04193189
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