Raul Raz, MD, Ronith Koren, PhD and David Bass, MD
Background: Previous data showed that new recombinant hepatitis B virus vaccine, which contains the S-protein component of the HBV surface together with the Pre-S1 and Pre-S2, is considerably more immunogenic than a second-generation recombinant I-IBV vaccine.
Objectives:To compare the immunogenicity and safety of a novel recombinant HBV vaccine S1, Pre-S1 and Pre-S2 protein components of the hepatitis B surface antigen - BioTM
HepTM 10 לg dose, to a licensed vaccine containing only the S-protein component - Engerix-B, 20 לg dose.
Methods: A prospective randomized study included 524 adults - 260 in the Bio-Hep group and 264 in the Engerix-B group. Both vaccines were administered in a three-dose regimen given at 0, 1 and 6 months, and adverse events were recorded on a diary card 5 days after each vaccination. lmmunogenicity was tested by measuring anti-hepatitis B surface antibody.
Results: One month after the third injection, 98% of the BioHepTM subjects were found to be seroprotected vs. 85.1% of the Engerix-B group. In addition, the geometric mean titers were 2,203 mlU/ml and 326 mlU/ml in the Bio-Hep-B and Engerix-B groups respectively. An immunogenic advantage of Bio-Hep-B was suggested by the rapid onset of antibody response - 66.5% were seroconverted one month after the first injection as compared to 19.3% in the Engerix-B group. No unexpected adverse events were observed, and the recorded events were mild in both groups.
Conclusions: BioHepTM, a novel recombinant HBV vaccine containing 5, Pre-S1 and Pre-S2 protein components. at a lower dose, is safe and more immunogenic than the conventional HBV vaccine that contains only S protein.
Manfred S. Green, MD, PhD, Gali Aharonowitz, MD, Tamy Shohat, MD, MPH, Rachel Levine, MD, Emilia Anis, MD, MPH and Paul E. Slater, MD, MPH
Background: Between 1970 and 1979, there was an increase in the incidence of viral hepatitis in Israel with a shift of peak incidence to an older age in the Jewish population, followed by a declining trend during the early 1980s. In July 1999 universal immunization of infants against hepatitis A was introduced.
Objective: To evaluate the chan-ges in the epidemiology of viral hepatitis A in Israel during the past decade.
Methods: Viral hepatitis is a notifiable disease in Israel and cases are reported to the regional health offices, which in turn provide summary reports to the Ministry of Health's Department of Epidemiology. The data in this study were derived from the summary reports and from results of seroprevalence studies.
Results: Following the increase in the incidence of reported viral hepatitis (mainly due to type A) between 1970 and 1979, the rates then stabilized and around 1984 began to decline until 1992. Since then there has been a slight increase. Whereas until 1987 the rates were consistently higher in the Jewish population. since then they are higher in the Arab population. The shift in the peak age-specific incidence from the 1-4 to the 5-9 year age group observed in the Jewish population around 1970 occurred 20 years later in the Arab population. The previously described seasonality is no longer evident. Recent seroprevalence studies indicate that by age 18 years only about 30-40% of the Jewish population have anti-hepatitis A antibodies.
Conclusions: The decline in the incidence of hepatitis probably reflects the changing socioeconomic condition occurring at different times in the two major population groups. Since hepatitis A accounts for almost all the acute viral hepatitis in Israel, the universal vaccination of infants introduced in 1999 should substantially lower the morbidity within the next few years.
Ayelet Berg, PhD, Dan Yuval, PhD, Michal Ivancovsky, MBA, Sima Zalcberg, MSc, Avigail Dubani and Jochanan Benbassat, MD
Background: Patients who feel involved in their treatment have better outcomes than those who do not.
Objective: To identify determinants of perceived patient involvement in obstetric care.
Methods: A retrospective study was undertaken in 1,452 (83%) of 1,750 women sampled in November 1995 from maternity wards of 14 general hospitals in Israel. A postal and telephone survey using a self-administered questionnaire included the following variables: hospital (identity number), patients' age, self-reported complications, previous deliveries, education, ethnicity, and number of obstetric interventions performed and/or considered. The main outcome measured was the reported involvement in decisions for obstetric interventions.
Results: Reported full involvement varied from 72% for epidural analgesia to 13% for forceps/vacuum extraction. Factor analysis identified two dimensions of perceived involvement: one for routine” interventions (enema, monitoring, IV line and episiotomy), which are performed in Israel mostly by midwives, and another for "special" interventions (forceps/vacuum extraction, epidural or other analgesia, and cesarian section) performed by physicians. Logistic regression identified hospitals, younger age, number of interventions, and Arab ethnicity as correlates of a perceived non-involvement in decisions for "special" interventions.
Conclusions: Clinical setting, age and ethnicity affected patient perception of involvement in decisions for obstetric interventions.
David Kershenobich, MD, PhD and Cristian Heinrich Henonin, MD
The hepatitis C virus is an enveloped positive-sense single-stranded RNA virus, which has been classified into 6 major genotypes and over 100 subtypes. HCV replicates mainly in the hepatocyte. Recently, infectious HCV cDNA clones have been generated. Despite evidence that innate and adaptative humoral and cellular immune responses are activated as part of an antiviral defense, HCV has a remarkable ability to establish persistent infection. The analysis of viral kinetics using mathematical modeling shows a relative steady state without treatment, while an immediate biphasic HCV decline occurs in blood during successful treatment, the latter being predictive of clearance of HCV by the end of treatment.
Yehuda Edoute, MD, PhD, Yuval Karmon, MD, Ariel Roguin, MD and Haim Ben-Ami, MD