DTwP-HBV-HIB vaccine(Biological E. Ltd.)

This study aimed to assess the safety of a fully liquid DTwP-HBV/Hib pentavalent vaccine (Eupenta^TM) based on the occurrence of adverse events (AEs) following vaccination.

This was a prospective, open-label, single-arm, interventional phase IV study. A single intramuscular injection of the study vaccine was administered to infants at approximately 6, 10, and 14 weeks of age, and an end-of-study follow-up visit was scheduled at 18 weeks.

In all, 3000 subjects were enrolled and received at least one dose of the study vaccine. Of these, 2717 (90.6%) experienced at least one AE. Immediate reactions, solicited and unsolicited AEs were respectively identified in 224 (7.5%), 2,652 (88.4%), and 1,099 (36.6%) subjects. The most prevalent solicited and unsolicited AEs comprised pain/tenderness and upper respiratory tract infection, respectively. Most AEs were mildly or moderately severe. Forty-one (1.4%) subjects had at least one serious AE (SAE); of these, two (0.1%) had two SAEs each, considered related to the study vaccine. Six (0.2%) subjects died due to unsolicited AEs, none of which were considered related to the study vaccine. No AEs were reported at the end-of-study follow-up visit.

The study vaccine  had a safety profile similar to that reported in a previous clinical study, and did not result in an increased risk of AEs known to be associated with DTwP-based vaccines or previously unrecognized SAEs.

Hematopoietic stem cell transplantation (HSCT) recipients require hepatitis B (HBV) revaccination. Hepatitis B surface antibody (anti‐HBs) seroconversion rates after revaccination range from 64% to 79% in these patients. The seroconversion rate and factors associated with non‐seroconversion have not been clearly elucidated in pediatric and young adult recipients after HSCT.

To evaluate anti‐HBs seroconversion rates in pediatric and young adult patients revaccinated after HSCT, and to identify factors associated with non‐seroconversion.

The current study was prospective and cross‐sectional. Post‐HSCT recipients aged ≤25 years who had completed a course of three HBV revaccinations were recruited, and their anti‐HBs titers were assessed. Non‐seroconverted patients were administered a fourth vaccination. Those who subsequently remained seronegative were administered two additional vaccinations. Those who remained seronegative after all six vaccinations were defined as non‐responders.

A total of 118 patients were enrolled. The HBV‐containing vaccines used included DTaP‐IPV‐HBV‐Hib, DTwP‐HBV‐Hib, and monovalent vaccines. The anti‐HBs seroconversion rate after three revaccinations was 82% (95% confidence interval [CI], 73.7‐89.2). One patient (0.8%) was classified as non‐responder. Factors associated with non‐seroconversion after three revaccinations included cytomegalovirus (CMV) reactivation (odds ratio [OR] 10.63, 95% CI 1.16‐97.00), anti‐HBs seronegativity before HSCT (OR 7.01, 95% CI 1.55‐31.78) and three DTwP‐HBV‐Hib revaccinations (OR 11.71, 95% CI 1.43‐96.26).

In the current study the anti‐HBs seroconversion rate after three HBV revaccinations was excellent. CMV reactivation, anti‐HBs seronegativity before HSCT, and three DTwP‐HBV‐Hib revaccinations were associated with non‐seroconversion, but the non‐responder rate was low.