Evaluation of safety and immunogenicity of hepatitis E vaccine in maintenance hemodialysis patients / 中华预防医学杂志

Objective: To evaluate the safety and immunogenicity of hepatitis E vaccine(HEV)in Maintenance hemodialysis(MHD)patients. Methods: Based on an open-labeled controlled trial, from May 2016 to March 2018, 35 eligible MHD patients were recruited in the Hemodialysis Center of Zhongshan Hospital Affiliated to Xiamen University as the experimental group, and 70 MHD patients with matched age, gender and underlying diseases as the control group. The experimental group received HEV at 0, 1 and 6 months according to the standard vaccination procedures, while the control group received routine diagnosis and treatment without vaccine and placebo injection to observe the safety and immunogenicity of the vaccine. The safety of vaccine in MHD population was evaluated by the incidence of adverse reactions/events in the experimental and control groups. The immunogenicity of HEV in MHD patients was evaluated by comparing the data from the phase Ⅲ clinical trial. Results: The overall incidence of adverse reactions/events was 17.1% (18/105), and there were no grade 3-4 adverse reactions/events related to vaccination. In the experimental group, the incidence of local adverse reactions/events was 20.0% (7/35), and the incidence of systemic adverse reactions/events was 17.1% (6/35).There was no significant difference in the incidence of systemic adverse reactions/events between the experimental group and the control group (P>0.05). There were 23 patients receiving 3 doses with the standard schedule. The positive rate of HEV-IgG antibody was 100% and the GMC was 14.47(95%CI:13.14-15.80) WU/ml, which showed no significant difference compared with the 46 patients in Phase Ⅲ clinical trial (t=-1.04, P>0.05). Conclusion: Recombinant HEV has good safety and immunogenicity in MHD patients.

Seroprevalence of hepatitis A virus in Mumbai, and immunogenicity and safety of hepatitis A vaccine.

OBJECTIVES: Since epidemiologic trends of hepatitis A are changing worldwide, we studied its seroprevalence in Mumbai, which is thought to be a high-endemicity area. The immunogenicity and safety of a hepatitis A vaccine were also studied. METHODS: Six hundred and seventy subjects (456 men; age range 6 mo-60 y) answered a questionnaire on social and medical history. Qualitative analysis of total anti-HAV was performed in all subjects by ELISA. One hundred and seven of 147 anti-HAV negative subjects received hepatitis A vaccine at months 0, 1 and 6. Subjects were followed up (months 1, 2, 6, 7) to look for side-effects and seroconversion. RESULTS: The seroprevalence of HAV was 523/670 (78%); 38% of children < 5 years were anti-HAV negative. Seroprevalence rates of 80% were reached by 15 years. Prevalence was lower in the higher socio-economic group (151/234; 64.5%) compared with the lower socio-economic group (372/436; 85%) (p < 0.001). One month after doses 1, 2 and 3 of the hepatitis A vaccine, seropositivity was 92%, 99% and 100%, respectively. Minor self-limited side-effects occurred in 19.5% of subjects; there were no major side-effects. CONCLUSIONS: The seroprevalence of anti-HAV is high in Mumbai. Seroprevalence is lower in the higher socio-economic groups. The hepatitis A vaccine is safe and immunogenic.

Immunogenicity and safety of an inactivated hepatitis A vaccine amongst Singaporeans.

The immunogenicity and reactogenicity of an inactivated hepatitis A virus (HAV) vaccine was studied in healthy Singaporean adult volunteers. One hundred and forty healthy volunteers with normal alanine (ALT) and aspartate (AST) transaminases and no previous exposure to HAV, received three 1 ml doses (720 ELISA units) of an inactivated HAV vaccine (Smithkline Beechams Biologicals) following a 0, 1, 6 months vaccination schedule. All subjects were asked to record and grade the severity of any reactions for three consecutive days after each dose. Serum ALT and AST as well as anti-HAV were measured at 0, 1, 2, 6 and 7 months after the first vaccine dose. Anti-HAV seroconversion occurred when levels rose above 40 mIU/ml. Eighty-five percent of vaccinees seroconverted after the first innoculation and 99% after the second injection. All vaccinees seroconverted after the third dose. Geometric mean anti-HAV titers (GMTs) were, respectively, 119, 391, 4406 mIU/ml one month after each of the three doses. The most common side effect was transient pain and tenderness at the vaccination site. No elevation of ALT or AST levels were noted during the study period. The inactivated hepatitis A vaccine used in this study is safe and highly immunogenic in the local adult population. Two doses one month apart appeared to give adequate protection.

Development of subcutaneous abscesses due to mycobacterium bovis following hepatitis and bacillus Calmette-Guerin vaccination

Vaccination to prevent hepatitis B and tuberculosis [TB] forms a part of the national immunization program in the Kingdom of Saudi Arabia. The hepatitis B vaccination was introduced in the Makkah region in January 1991G. Since then, 25 children have developed post vaccination subcutaneous abscesses at the site of vaccination. Microbiological studies proved these to be of bacillus Calmette-Guerin vaccine [BCG] origin. Ten patients were treated successfully with isoniazid [INH] and rifampicin and 15 with INH alone. Four patients required incision and drainage. Possible reasons for this complication in our patients are discussed