OBJECTIVES: Hepatitis B co-infection may lead to increased mortality of HIV patients. All HIV-infected patients are recommended to receive hepatitis B virus (HBV) vaccination to prevent the co-infection. However, HIV-infected patients often fail to produce protective antibodies to HBV vaccine. This study is sought to assess the efficacy of increased-dose HBV vaccine in HIV-infected patients. METHODS: A systematic literature review and meta-analysis of clinical trials were conducted. The search was carried out on PubMed, EMBASE and the Cochran Database of Systematic Reviews, from beginning of databases to December 2013. Keywords used in the electronic searches included “hepatitis b”, “HBV”, “vaccine”, “vaccination”, “immunization”, “HIV”, and “ADIS”. We only included studies those published in full-text papers. Inclusion criteria are as follows: English language and randomized control trials those compare the response rates of increased-dose HBV vaccine (increase dose or administration times of standard dose) and standard-dose vaccine (20μg 3 times at month 0, 1, and 6) in HIV-infected patients. Random effect model with heterogeneity analyses were used. The result was reported by risk ratio. Statistical analyses were performed using the software program Review Manager 5.2. RESULTS: Of 1204 references yielded by electronic searches, five trials, which represent a total of 424 patients, were included in the final analysis. The heterogeneity was moderate (I=32%) according to the Itest. Pooling of study results showed a significant increase in response rate among increased-dose patients versus control patients; the pooled risk ratio (RR) was 1.17 (95% CI: 1.06-1.30). The number of intent-to-treat is 9. Only one study presented severe adverse reaction reports related to the vaccination, and no increased risk was observed. CONCLUSIONS: Increasing the dosage of vaccine may improve the immune responses significantly in HIV-infected patients.