ABSTRACT
BACKGROUND: The objectives of this trial were to test for noninferiority of a virosomal hepatitis A virus (HAV) vaccine (Epaxal) coadministered with routine childhood vaccines compared with Epaxal given alone and to an alum-adjuvanted HAV vaccine (Havrix Junior) coadministered with routine childhood vaccines. METHODS: Healthy children 12- to 15-month-old were randomized to receive either a pediatric dose (0.25 mL) of Epaxal coadministered with DTPaHibIPV, oral polio vaccine, and measles-mumps-rubella vaccine (n = 109; group A), or Epaxal given alone (n = 105; group B), or Havrix Junior coadministered with DTPaHibIPV, oral polio vaccine, and measles-mumps-rubella vaccine (n = 108; group C). A booster dose was given 6 months later. Anti-HAV antibodies were tested before and 1 month after each vaccination. Safety was assessed for 1 month after each vaccination. Solicited adverse events were assessed for 4 days after each vaccination. RESULTS: : HAV seroprotection rates (> or =20 mIU/mL) at 1 and 6 months after first dose were: A: 94.2% and 87.5%, B: 92.6% and 80.0%, C: 78.2% and 71.3%, respectively (A versus C: P < 0.001 and P = 0.017 at month 1 and 6, respectively). The respective geometric mean concentrations were: A: 51 and 64 mIU/mL, B: 49 and 59 mIU/mL, C: 33 and 37 mIU/mL (A versus C: P < 0.001 at both time points). All groups achieved 100% seroprotection after the booster dose. The geometric mean concentrations after the booster dose were 1758, 1662, and 1414, for groups A, B and C, respectively (A versus C: P = 0.15). No clinically significant reduction in immune response to all concomitant vaccine antigens was seen. All vaccines were well tolerated. CONCLUSIONS: : Coadministration of pediatric Epaxal with routine childhood vaccines showed immunogenicity and safety equal to Epaxal alone as well as to Havrix Junior. After first dose, Epaxal was significantly more immunogenic than Havrix Junior.
Subject(s)
Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Hepatitis A Vaccines/administration & dosage , Hepatitis A Vaccines/immunology , Measles-Mumps-Rubella Vaccine/administration & dosage , Poliovirus Vaccines/administration & dosage , Vaccines, Virosome/administration & dosage , Enzyme-Linked Immunosorbent Assay , Female , Hepatitis A/prevention & control , Hepatitis A Antibodies/blood , Hepatitis A Vaccines/adverse effects , Hepatitis A Virus, Human/drug effects , Hepatitis A Virus, Human/immunology , Humans , Immunization Schedule , Infant , Israel , Male , Vaccines, Virosome/adverse effectsABSTRACT
The aim of this study was to determine the prevalence of hepatitis C virus antibodies in high rosk patients coming from Valdivia, Osorno and Puerto Montt. Fiftysix patients in hemodialysis, 51 renal grafts recipients, 42 cirrhotic and 14 patients with acute non A non B hepatitis were studied. Antibodies were detected with a second generation ELISA technique and positive cases were confirmed with RIBA. All hemodialysis patients and renal grafts recipients were negative for hepatitis C virus antibodies. In one non alcoholic patient with cirrhosis, a positive ALISA was confirmed with RIBA. Six patients with acute hepatitis had a positive ALISA tests but none was confirmed with RIBA. It is concluded that the prevalence of hepatitis C virus antibodies in this region of Chile is very low