Phase 1 trial of a candidate rotavirus vaccine (RV3) derived from a human neonate

Objective: To conduct a phase 1 safety and tolerability trial of an oral rotavirus vaccine candidate RV3 in healthy volunteers.
Methodology: Double blind placebo controlled trial of a single 1 mL oral dose (6.5 × 10⁵ fluorescing focus units [FFU]/mL) in 10 healthy young men, 10 3–4 year old children and 10 3 month old infants with a 4 week surveillance period. The study was undertaken at a children's hospital and nearby community in Melbourne, Australia.
Results: All subjects successfully completed the trial. There were no significant side-effects attributable to the vaccine preparation in any age group. No shedding of vaccine virus was detected by enzyme immunoassay. There was evidence of an. immune response in serum and/or gut secretions in two of five vaccinees in each age group.
Conclusion: RV3 rotavirus vaccine appears to be safe and well tolerated. Evidence of immunogenicity in some subjects after a single dose encourages further trials to determine immunogenicity after three doses, after reduction of viral dose, and without prior administration of buffer.     

Characterization of Radiologists’ Search Strategies for Lung Nodule Detection: Slice-Based Versus Volumetric Displays

The goal of this study was to assess whether radiologists’ search paths for lung nodule detection in chest computed tomography (CT) between different rendering and display schemes have reliable properties that can be exploited as an indicator of ergonomic efficiency for the purpose of comparing different display paradigms. Eight radiologists retrospectively viewed 30 lung cancer screening CT exams, containing a total of 91 nodules, in each of three display modes [i.e., slice-by-slice, orthogonal maximum intensity projection (MIP) and stereoscopic] for the purpose of detecting and classifying lung nodules. Radiologists’ search patterns in the axial direction were recorded and analyzed along with the location, size, and shape for each detected feature, and the likelihood that the feature is an actual nodule. Nodule detection performance was analyzed by employing free-response receiver operating characteristic methods. Search paths were clearly different between slice-by-slice displays and volumetric displays but, aside from training and novelty effects, not between MIP and stereographic displays. Novelty and training effects were associated with the stereographic display mode, as evidenced by differences between the beginning and end of the study. The stereo display provided higher detection and classification performance with less interpretation time compared to other display modes tested in the study; however, the differences were not statistically significant. Our preliminary results indicate a potential role for the use of radiologists’ search paths in evaluating the relative ergonomic efficiencies of different display paradigms, but systematic training and practice is necessary to eliminate training curve and novelty effects before search strategies can be meaningfully compared.     

Flexibilized gelatin film-based artificial skin model: II. Release kinetics of incorporated bioactive molecules.

Any delivery system for bioactive molecules should have the ability to release the compound in question in a reproducible and predictable way over a certain period. For artificial skin models that are designed to enhance healing by the use of growth factors, this requirement poses another problem: the design of a delivery method that can provide a realistic assessment of the release kinetics. This means that the design should "mimic" conditions encountered in an open wound, i.e., only a certain part of the film can face the wound, from which it can absorb wound fluid that will dissolve the incorporated bioactive molecule and bring it to the open wound. Such a system has been developed and the release of 125I-labelled insulin, incorporated into flexibilized gelatin films, has been determined. The details of this study follow.     

IMPORTANCE OF PROSTATIC SPECIFIC ANTIGEN (PSA) IN CLINICAL PRACTICE : OUR EXPERIENCE

A total of 89 patients in the age group of 50-92 years having different histopathologically proven prostatic conditions were analysed with prostate specific antigen (PSA) and clinical co-relation undertaken. PSA levels were found to be significantly higher (p < 0.05) in 48 carcinoma prostate cases (mean 93.16 ± 50.75 ng/ml) as compared to 32 benign prostatic hyperplasia (mean 4.66 ± 3.85 ng/ml). Similarly, levels were considerably reduced in 15 post-operative adenocarcinoma cases (mean 10.77 ± 9.65 ng/ml) as compared to their pre-operative samples (mean 93.16 ± 60.75 ng/ml). PSA levels were moderately higher in 9 cases of prostatitis (mean 13.28 ± 4.53 ng/ml). A very high degree of sensitivity, specificity and positive predictive value of PSA e.g. 95.8%, 75.6% and 82.2% respectively was found in adenocarcinoma cases, when levels of PSA were > 10 ng/ml. Thus it necessitates a detailed and thorough examination in such cases to come to final conclusion and early management of the cases.KEY WORDS: Prostatic Specific Antigen (PSA)     

MECKEL'S DIVERTICULUM – REVISITED

Twenty five cases of Meckel''s diverticulum were studied between 1985-1995. Eight of these were symptomatic and in the remaining 17 it was an incidental finding. The symptomatic patients presented with intestinal obstruction (5 cases), perforated peritonitis (2 cases) and intussusception (1 case). All cases of acute appendicitis were also subjected to a search for Meckel''s diverticulum. Of the 25 Meckel''s diverticuli encountered, 22 were resected and in 3 patients it was left in situ. Both the patients with perforated Meckel''s diverticulum showed ectopic gastric mucosa. Complications occurred only after surgery for symptomatic Meckel''s diverticulum. All patients undergoing incidental diverticulectomy had a smooth and uncomplicated recovery.KEYWORDS: Incidental diverticulectomy, Meckel''s diverticulum