Immunogenicity and safety of IXIARO (IC51) in a Phase II study in healthy Indian children between 1 and 3 years of age.

For adults the standard administration of the Japanese encephalitis vaccine IXIARO is two injections of 6 microg in a 28-day interval. Immunogenicity and safety of 3 and 6 microg of IXIARO compared to JenceVac were investigated in 60 healthy Indian children aged between 1 and 3 years. JE specific neutralizing antibodies were measured at baseline and 28 days after the first and second vaccination. On Day 56 SCR of the 3 and 6 microg IXIARO and the JenceVac group were 95.7%, 95.2% and 90.9%, respectively, and GMT were 201, 218 and 230, respectively, both without statistically significant difference between the three groups. Local and systemic tolerability were captured in a diary 7 days post-vaccination. No apparent difference was seen in the safety profile between the vaccines. These first immunogenicity and safety data in children are promising and support the use of a 3 microg dose in children below the age of three for further development of IXIARO in the paediatric population.

Safety and immunogenicity of concomitant vaccination with the cell-culture based Japanese Encephalitis vaccine IC51 and the hepatitis A vaccine HAVRIX1440 in healthy subjects: A single-blind, randomized, controlled Phase 3 study.

In travellers often several pre-departure immunizations are indicated, thus data are needed about possible interactions between vaccines. This Phase 3 study investigated the immunogenicity and safety of IC51 (JE vaccine) and HAVRIX1440 (hepatitis A vaccine) when administered alone or concomitantly to healthy subjects. The immune response was compared between single and concomitant vaccination in terms of geometric mean titre (GMT) and seroconversion rate (SCR) on Days 28 and 56. Immunogenicity was comparable for the 2 vaccines whether given together or separately which suggests that travellers to such regions could receive the vaccinations concomitantly.

Clinical fit of Procera AllCeram crowns.

STATEMENT OF PROBLEM: Color stability, strength, and accuracy of fit are the main requirements for complete-ceramic crowns. The Procera AllCeram crown system is a CAD/CAM system used to fabricate individual complete-ceramic crowns that have a dry sintered, aluminum oxide core and appear to match clinical requirements. However, there are few articles about the clinical fit of all-ceramic crowns. PURPOSE: This in vivo study measured the accuracy of fit of Procera AllCeram crowns in anterior and posterior teeth. MATERIAL AND METHODS: The clinical fit of 80 anterior and posterior Procera AllCeram crowns was evaluated by a replica technique with a light body silicone to fill space between crown and tooth and a heavy body silicone to stabilize the light body film. After removal from the artificial crowns, the replicas were segmented, and measurements of the film thickness were performed with a light microscope. RESULTS: Medians of mean marginal gap widths were between 80 and 95 microm in anterior teeth and between 90 and 145 microm in posterior teeth. Medians of maximal marginal gap widths ranged from 80 to 180 microm in anterior teeth and from 115 to 245 microm in posterior teeth. CONCLUSION: The accuracy of fit achieved by Procera AllCeram was comparable to other conventional and innovative systems.

[Utilization of dental services--results of an oral hygiene study in Saxony]. / Inanspruchnahme zahnärztlicher Dienste--Ergebnisse einer Mundgesundheitsstudie in Sachsen.

The utilisation of dental services is a precondition for professional preventive measures. The representative oral survey "Bevölkerungsrepräsentative Studie zum zahnärztlich-prothetischen Versorgungsgrad und Behandlungsbedarf" aimed at gaining data on the frequency and motives for dental visits and the existence of barriers. The sample consisted of 714 subjects aged fifteen years and older. It was representative for the German Federal State Saxony. Socio-economic and behavioural data were collected via self-completed questionnaire. The caries history was evaluated by assessing the DMFT Index. Data collection in 1996 was carried out by three calibrated dentists. Utilisation of dental services was found to be high. Subjective barriers played no crucial role in the decision to utilise dental services. Costs as an objective barrier to dental visits had a growing importance with age. Lower rates of tooth loss and enhanced levels of restoration were found in subjects aged over 24 years who regularly utilised dental services compared to subjects with non-regular utilisation. These differences were significant for subjects over 54 years (tooth loss) and subjects aged 25-44 years and over 54 years (level of restoration). Compared to previous studies the utilisation was similar or higher in our sample. The enhanced oral health belief paves the way for professional preventive measures. In the over 64-year-olds the need for regular dental visits was obvious and this age group must definitely be given more relevant information on the subject.

[Temporary skin replacement with lyophilized swine skin and foam substances--comparative experimental studies]. / Passagerer Hautersatz mit lyophilisierter Schweinehaut und Schaumstoffmaterialien--vergleichende experimentelle Untersuchungen.

Using the skin replacement materials Corethium 2, Coldex, Epigard and SYSpur-derm, both fresh wound and wounds up to 6 days old were covered in rats. The histological work-up 1-7 days later showed material-dependent differences in the wound reaction. Under Corethium 2, a heavy layer of wound exudate formed on the first day both on fresh and granulating wound surfaces. Beneath this layer granulation tissue formed that was of regular thickness and well vascularized, filling the defect. Reepithelialization of the wound surface was not hindered by the material. In contrast, a strong connection was established between the wound base and the covering material when using the three foam substances Coldex, Epigard and SYSpur-derm, through the formation of granulation tissue. This process was dependent on the age of the wound. Thickening of the granulation tissue under the covering material was suppressed by the foam substances. Reepithelialization of the surface of the wound was disturbed by the growth of granulation tissue. The netlike structure of Epigard and the properties of the cover layer (fluid-resistant and protective against bacteria) make it possible for the granulation tissue to infiltrate evenly in the whole area of the wound covering and permit growth within the material right up to the surface. In addition to granulation tissue, epithelium also grows into the foam and spreads evenly. Epigard is suitable for long-term covering of large wounds. SYSpur-derm has a different fine structure than Epigard, which hinders the growth of granulation tissue, so that there are only cone-shaped connections between the wound base and the covering material. Rapid desiccation of the wound exudate cannot be prevented. Leukocytes and granulation tissue cannot spread in the foam. With SYSpur-derm an intermediate layer of wound exudate was observed more frequently than with Epigard. SYSpur-derm should be changed regularly in order to remove the detritus and exsudate from the wound. In comparison with polyurethane foam material the polyvinyl-alcohol foam (Coldex) was more complicated to handle, did not adapt as well to the wound, and dried up within a few hours. Between the base of the wound and Coldex, an intermediate layer often formed and, because of the rapid drying-out process, there was appreciably less infiltration with leukocytes and granulation tissue than with SYSpur-derm. With Coldex, as a rule the granulation tissue was more generously vascularized than in the other three materials.