Immunogenicity and Persistence of Hepatitis B Vaccination in HIV-Infected Patients

Summary

At present, HIV-Infected Patients of Hepatitis B Vaccination in are vaccinated with hepatitis B vaccine according to the standard three-dose schedule immunization program, and the effect of preventing HBV infection is not ideal. This is a randomized, controlled trial. The study will evaluate the immunogenicity and persistence of 20 µg and 60 µg recombinant hepatitis B vaccine with three or four injections at months 0, 1, and 6 or 0, 1,2, and 6 in HIV-Infected Patients

Timeline

Start

2019-06-05

Primary completion

2020-02

Completion

2023-12

Outcome

Met primary endpoint

paper At week 28, the seroconversion rate and GMC of anti-HBs in both IM20 × 4 and IM60 × 4 groups were significantly higher PMID 35312441 ↗

paper IM20 × 4 and IM60 × 4 groups were significantly higher than those in the IM20 × 3 group (P < 0.05) PMID 35312441 ↗

paper both the four standard-dose and high-dose regimens significantly improved immunogenicity. PMID 35312441 ↗

Publications

• Feng Y, Chen Z, Xie R, Yao T, Wu Y, Yang F, Yuan C, Nie X, Wang F, Liang X, Wang S. Immunogenicity and safety of 4 intramuscular standard-dose and high-dose hepatitis B vaccine in people living with HIV: a randomized, parallel-controlled trial. Expert Rev Vaccines. 2022 Jun;21(6):861-868. doi: 10.1080/14760584.2022.2056024. Epub 2022 Apr 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	recombinant hepatitis B vaccine	Vaccine	20 ug	Intramuscular
Subject	recombinant hepatitis B vaccine	Vaccine	60 ug	Intramuscular

Indications