Immunogenicity and safety of a new inactivated hepatitis A vaccine: a clinical trial with comparison of administration route.

A bicentre, controlled, randomized, open trial was carried out in order to compare the immunogenicity and the reactogenicity of PASTEUR MERIEUX Sérums et Vaccins inactivated Hepatitis A Vaccine on adults, when used with different routes of administration [intramuscular (i.m.), subcutaneous (s.c.) and needless injection using a Jet injector device]. Vaccines were given at two doses 6 months apart to 147 seronegative subjects. Anti-Hepatitis A virus (HAV) titres were performed at each visit by modified radioimmunoassay assay. After the first dose, 138 subjects except one seroconverted (s.c.). After booster dose, all subjects exhibited high levels of HAV antibodies. The higher titres were observed with Jet injector (GMT: 305 mIU ml-1 after the first dose and 3727 mIU ml-1 after the booster dose), followed by the i.m. route (210 mIU ml-1, 3152 mIU ml-1) and the s.c. route (165 mIU ml-1, 2082 mIU ml-1). No statistically significant differences were observed in the three paired comparisons (i.m. vs jet injector; jet vs s.c., im vs s. c.). This inactivated hepatitis A vaccine appeared to be highly immunogenic after one single dose and one booster 6 months later.

Seroprevalence of hepatitis A virus infection among sewage workers in the Parisian area, France.

Sewers are an ideal environment to be occupationally exposed to viral hepatitis A (HAV) infection, because of high frequency and ability of the virus to remain viable for prolonged periods in sewage. However, data on the occupational risk of HAV infection among sewage workers is not well documented. In a cross sectional study comparing sewage workers (n = 155) to those not occupationally exposed to it (n = 70), we found a non significant increase in HAV seropositivity among sewage workers of 12.9% (p = 0.07). The prevalence of HAV antibody was significantly associated with duration of occupational exposure to sewage (p < 0.015), stay in HAV endemic areas (p < 0.03), age (p < 0.001), and number of siblings (p < 0.03). A stepwise logistic regression analysis gave an adjusted odds ratio for HAV seropositivity 2.15 fold greater in sewage workers compared to those not occupationally exposed to it. So, although there was no significant difference in the prevalence of HAV antibody between sewage workers and others, exposure to sewage was an independent risk factor for HAV seropositivity, and this raises the question of whether it is necessary to vaccinate sewage workers against viral hepatitis A.

[Influence of the risk factors of atherosclerosis on the onset of early peri-operative complications in peripheral arterial surgery]. / Influence des facteurs de risque de l'athérosclérose sur la survenue de complications péri-opératoires précoces de la chirurgie artérielle périphérique.

The influence of classical atherosclerosis risk factors (male sex, smoking, hypercholesterolemia, diabetes, overweight and hypertension on peri-hospital mortality and morbidity were studied in 83 patients (68 men and 15 women) aged 63 +/- 13 years and undergoing peripheral arterial surgery. None of these factors was statistically correlated with peri-operative complications with the exception of hypertension but the correlation was slight (0.5 less than p less than 0.10). In contrast, there was a powerful statistical (p less than 0.0003) link between age and morbidity and mortality associated with this type of surgery.

Assessment by dipyridamole-thallium-201 myocardial scintigraphy of coronary risk before peripheral vascular surgery.

From October 1983 to January 1985, 46 patients (38 men and 8 women; average age, 60 years; range, 37 to 83 years) underwent peripheral vascular surgery of either the internal carotid artery or the arteries of the lower limbs. Each patient had a thorough clinical examination, an ECG, and a dipyridamole-thallium-201 myocardial scan before operation. On the basis of results, they were divided into two groups: 20 patients with and 26 patients without chronic ischemic heart disease. Three major cardiac events were noted during or after a period of 1 month after surgery: There were two deaths due to cardiac ischemic events and one patient had postoperative unstable angina pectoris. These three patients were classified in the coronary group (NS). When the patients were classified on the basis of whether or not there was thallium redistribution on serial images after infusion of dipyridamole, 14 with redistribution and 32 without redistribution were noted. The three patients who had major cardiac events were in the former group (p less than 0.04). Our data suggest that patients in whom redistribution occurs have a high incidence of postoperative ischemic events. These patients should be considered for particular preoperative coronary care to avoid major postoperative cardiac events and to increase chances of survival.

[Evaluation by myocardial thallium-201 scintigraphy using dipyridamole of the coronary risk in peripheral vascular surgery]. / Evaluation par la scintigraphie myocardique au thallium 201 avec dipyridamole du risque coronarien de la chirurgie vasculaire périphérique.

From October 1983 to January 1985, 46 patients (38 men and 8 women; mean age 60 years, range 37-83) underwent peripheral vascular surgery either of the internal carotid artery or of arteries of the lower limbs. All patients had thorough clinical examination, ECG and thallium dipyridamole myocardial scanning before operation, as a result of which they were divided into 20 with, and 26 without chronic ischemic heart disease. Three major cardiac events were noted during or following a period of one month after surgery: two deaths due to a cardiac ischemic event and one post-operative unstable angina pectoris. The three patients with these complications were classified in the coronary group (NS). When the patients were reclassified according to the presence or absence of thallium redistribution on serial images after dipyridamole, 14 had redistribution and 32 had no redistribution. The three major cardiac events were found to have occurred in the group with redistribution (P less than 0.04). Our study suggests that patients with redistribution have a high incidence of postoperative ischemic events. They should be considered for a particular pre-operative coronary management to avoid post-operative major cardiac events and to improve survival.

[Statistical study of the profitability of recording cardiac electric activity by Holter's technic in diagnostic practice. Apropos of 200 cases]. / Etude statistique de la rentabilité de l'enregistrement de l'activité électrique cardiaque, par la technique de Holter, en pratique diagnostique. A propos de 200 cas.

The ambulant recording of the electrocardiogram by the Holter technique has become one of the non invasive examinations widely used in two indications: paroxysmal arrhythmias and coronary disease. However, the technical limitations of the method and the occasionally improper extension of the indications of Holter recording lead to disappointing results. The aim of this work is an estimation of the usefulness of Holter as a function of the desired information by a statistical study. Of 646 consecutive recordings, 200 were taken at random; 169 usable ones were classed in 7 categories according to the clinical requirement; the overall usefulness amounts to 27.5 percent of the cases in which Holter permits a diagnosis. As far as paroxysmal disturbances of rhythm are concerned, Holter is more efficacious than the standard electrocardiogram. However, the efficiency of the method is low: 17.4 percent of cases when it was required to find a cardiac arrhythmia causing a cerebral vascular accident, and even lower, 5.1 percent, when a malaise was concerned. In 20 percent of the cases was a useful tool in diagnosing thoracic pain. In 9.5 percent of the cases the tracings were not interpretable owing to their poor quality. These findings urge more rigor in the choice of indications and a better control of technical problems if the efficacy of the method is to be improved.