A5379: B-ENHANCEMENT OF HBV VACCINATION IN PERSONS LIVING WITH HIV (BEeHIVe): Evaluation of HEPLISAV-B
Study of HBV Vaccination (HEPLISAV-B) in Patients with HIV
Sponsor: NIH
Enrolling: Male and Female Patients
IRB Number: AAAS7965
U.S. Govt. ID: NCT04193189
Contact: Anyelina Cantos: 646-856-1648 / ac4314@cumc.columbia.edu
Additional Study Information: This study is looking at hepatitis B virus (HBV) vaccination in adults 18 to 70 years of age living with HIV around the world. Hepatitis B is a serious viral infection that affects the liver and is transmitted through blood and body fluids. A vaccine (a shot of medicine given through a needle) can prevent HBV, but there is no cure. A new vaccine approved by the United States Food and Drug Administration (FDA), called HEPLISAV-B, has been shown to provide a better response in other people who have not responded well to the older HBV vaccines. The purpose of this study is to find out whether this vaccine, HEPLISAV-B, will prove to be more effective in adults living with HIV than the current standard, ENGERIX-B vaccine. There are two groups of individuals in this study, Group A and Group B. Group A, will include individuals who have received a previous HBV vaccination but did not respond well to the vaccine. Group B will include individuals who have never received a HBV vaccination. If you are in Group A, you have an equal chance of receiving either two shots of HEPLISAV-B, three shots of HEPLISAV-B, or three shots of ENGERIX-B (current standard HBV vaccine). If you are in Group B, you will receive three shots of HEPLISAV-B. You will be compensated for your time and travel.
This study is closed
Investigator
Michael Yin, MD
Do You Qualify?
Are you between 18-70 years of age? Yes No
Have you been diagnosed with HIV? Yes No
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For more information, please contact:
Anyelina Cantos
ac4314@cumc.columbia.edu
646-856-1648