Immunogenicity and Safety of Hepatitis A Vaccine in Children With Chronic Liver Disease

• Published in: Journal of pediatric gastroenterology and nutrition Vol. 37; no. 3; pp. 258 - 261
• Main Authors: Ferreira, Cristina Targa, Silveira, Themis Reverbel, Vieira, Sandra Maria, Taniguchi, Adriano, Pereira‐Lima, Jorge
• Format: Journal Article
• Language: English
• Published: Hagerstown, MD Lippincott Williams & Wilkins, Inc 01.09.2003; Lippincott
• Subjects: Adolescent; Antibodies, Viral - blood; Biological and medical sciences; Child; Child, Preschool; Chronic Disease; Chronic liver disease children; Cirrhosis; Epidemiology. Vaccinations; Female; General aspects; Geometric mean titers; Hepatitis A - prevention & control; Hepatitis A Antibodies - blood; Hepatitis A vaccine; Hepatitis A Vaccines - adverse effects; Hepatitis A Vaccines - immunology; Hepatitis A virus; Humans; Immunization; Infant; Infectious diseases; Liver Diseases - immunology; Male; Medical sciences; Prospective Studies; Treatment Outcome; Tropical medicine; Vaccines, Attenuated - adverse effects; Vaccines, Attenuated - immunology; South America; Brazil; America; Human; Hepatic disease; Vaccine; Infection; Viral hepatitis A; Immunoprophylaxis; Chronic; Efficiency; Hepatitis A virus-Hepatitis A vaccine-Immunization- Geometric mean titers-Cirrhosis-Chronic liver disease children; Viral disease; Digestive diseases; Clinical trial; Superinfection; Safety; Child
• ISSN: 0277-2116; 1536-4801
• DOI: 10.1002/j.1536-4801.2003.tb11991.x

ABSTRACT Background Acute hepatitis A superimposed on chronic liver disease has been associated with a more severe course of disease and development of fulminant hepatitis. The aim of this study was to evaluate the immunogenicity and safety of an inactivated hepatitis A virus vaccine in children with chronic liver disease. Patients and Methods This was an open, prospective, and controlled trial with 89 anti‐HAV negative children between 1 and 16 years of age studied at a pediatric liver disease and transplantation referral center. Inactivated HAV vaccine (Havrix), from GlaxoSmithKline Biologicals containing 720 Elisa units of alum‐adsorbed hepatitis A antigen per 0.5 ml dose was used. Thirty‐four pediatric patients with chronic liver disease (mean age: 7.0 ± 4.86 years) and 55 healthy controls (mean age: 4.8 ± 2.7 years) received two doses of Havrix vaccine in months zero and six. Seroconversion and anti‐HAV titers expressed as geometric mean titers (GMT) in mIU/ml were measured at months one and seven, by a modified Hepatitis A virus andibodies (HAVAB) assay. Results Seroconversion rates at four weeks after primary immunization were 76% and 94% and the GMT 107.77 and 160.77 mIU/ml in the patient and control groups, respectively. One month after second dose the seroconversion rates were 97% and 100% in the groups with GMT of 812.40 and 2344.90 mIU/ml. Both doses were well tolerated with no significant adverse events observed. Local injection‐site symptoms were the most common reactions reported in both groups. Conclusion Although GMTs were significantly lower in children with chronic liver disease compared to healthy controls, the overall seroconversion rates were not different. Hepatitis A virus vaccine was safe, well‐tolerated, and immunogenic in children with chronic liver disease.