Plain-English translation of NCT04193189 on ClinicalTrials.gov β Β· Source last updated Β· Translation generated Β· How we translate trials
Read our Hepatitis B research guide βPhase 3 β Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This study evaluated a hepatitis B vaccine called in people living with HIV. Researchers tested whether this new medication worked better than the standard hepatitis B vaccine, either given as 2 or 3 doses, especially for people whose bodies didn't respond well to older vaccines. The trial included two groups: people who hadn't responded to hepatitis B vaccines in the past, and people who had never been vaccinated against hepatitis B before.
People living with HIV often have weaker immune responses to hepatitis B vaccines, leaving them unprotected even after vaccination. This medication was designed to work better in people with HIV, potentially offering protection to those who couldn't be protected by standard vaccines.
Participants attended multiple visits over 18 months and received injections of the medication on a schedule determined by their study group (either 2 or 3 doses spaced weeks apart). At each visit, they had physical exams and blood tests to check how well their immune system responded to the vaccine. For 7 days after each injection, participants recorded their temperature and any side effects they experienced at home. Everyone continued taking their regular HIV medications throughout the study.
AI-generated summary from trial data Β· Sep 24, 2026 Β· Not medical advice
United States