A Randomized Study Comparing the Efficacy of Three Hepatitis B Vaccine Induction Regimens in Adult Patients with Hematological Malignancies

Abstract

Objective:Non-responsiveness to hepatitis B virus (HBV) vaccines is not rare in hemato-oncological patients due to disease-associated or treatment-induced immune suppression. Although different strategies have been employed to improve the response rates, to date there is not an approved schedule for HBV immunization in patients with hematological malignancies. We designed a prospective randomized study to evaluate the efficacy of 3 different induction regimens for HBV vaccination.Materials and Methods:In the standard-dose (SD) group, total vaccine dose delivered was 40 µg and patients were vaccinated with 20 µg at weeks 0 and 4. In the high-dose dose-intensive (HDDI) group, total vaccine dose delivered was 80 µg and patients were vaccinated with 40 µg at weeks 0 and 4. In the high-dose time-intensive (HDTI) group, total vaccine dose delivered was 80 µg and patients were vaccinated with 20 µg at weeks 0, 2, 4, and 6.Results:In a cohort of 114 patients, 38.6% responded to HBV vaccination. The response rate in the SD arm, HDDI arm, and HDTI arm was 26.2%, 29.7%, and 44.4%, respectively (p>0.05). Age was the only variable identified as having a negative impact on response.Conclusion:Short of achieving statistical significance, a higher response rate was observed in the HDTI arm. Therefore, this study supports a high-dose, time-intensive HBV vaccine induction regimen in patients with hematological malignancies who are not on chemotherapy.

Efficacy of COVID-19 Booster Vaccines in Patients with Hematologic Malignancies: Experiences in a Real-World Scenario

“…Overall, only 55% of our patients were observed with a successful seroconversion after a prime-boost vaccination (third COVID-19 vaccine). Such a low response rate is consistent with the observation of impaired humoral responses to both non-COVID-19 anti-infective vaccinations [ 39 , 40 , 41 ] and mRNA-based COVID-19 booster vaccines [ 29 , 31 , 42 , 43 , 44 ] in patients with hematologic neoplasms. In a small proportion of analyzed patients with myeloid neoplasms, the seroconversion rate was higher compared to those with lymphoid ones (78% vs. 54%, accordingly).…”

Hepatitis B Virus Screening and Management for Patients With Cancer Prior to Therapy: ASCO Provisional Clinical Opinion Update

“…Among patients who have isolated anti-HBc-positive with negative HBsAg and anti-HBs, studies have shown that protective levels of anti-HBs can decrease risk of HBV reactivation, [19][20][21] Thus, future research should assess the efficacy of HBV vaccination to achieve protective anti-HBs levels, 53 which could decrease risk of HBV reactivation. [19][20][21] In the United States, the rise in the acute HBV infection due to the opioid crisis 54 may be shifting national HBV screening and vaccination practices to expand.…”

Screening, monitoring, prevention, prophylaxis and therapy for hepatitis B virus reactivation in patients with haematologic malignancies and patients who underwent haematologic stem cell transplantation: a systematic review

“…In a prospective study, a poor vaccination response in adult haematologic patients was reported [54], suggesting the need for alternative vaccine schedules to prevent the acquisition of HBV infection. In a recent randomized study, four single 20 mg HBV vaccine doses administered at 0, 2, 4 and 6 months led to an anti-HBs antibody response in 44.4% of adult patients with haematologic malignancies who were not receiving chemotherapy [55] ( Supplementary Appendix 5).…”