Biomedical subjects

R Koren

Publications and source records attributed to R Koren.

At least 55 records · Page 3Linked to original sources

PubMed1999

Patterns of proliferative changes in crypts bordering colonic tumors: zonal histology and cell cycle marker expression.

Proliferative crypt changes have been noted in mucosa bordering colonic carcinomas, but their biological significance is disputed. We anticipated that zonal patterning of histological changes and cell cycle marker expression would provide clues to the pathogenesis of these border changes. 81 specimens were examined including carcinomas, adenomatours polyps, adenomas with early carcinoma, flat adenomas and aberrant crypt foci. The spatial distribution and frequency of micro-architectural features, and mucosal thickness were determined in a border domain of 150 300 sequential crypts/specimen. Immunocytochemical expression of Ki67 and p53 antigens in crypts also was semi-quantitatively examined. We found that in 100% of carcinomas two histologically abnormal zones (Proximate and Middle) separated tumor from normal mucosa. Differences in the feature frequency between zones were statistically significant (p<0.05). Both zones showed mild increases in crypt cell expression of Ki67, with a statistically significant relationship to zonal patterning (p<0.005). Weak expression of p53 only appeared in rare cells. Crypt elongation with mucosal thickening (1.9x normal, p<0.001) in the Proximate and Middle zones distinguished carcinomas from border changes in all benign lesions, except flat adenomas. Since this change occurs in all cases of carcinoma, there is no correlation with tumor stage or grade. Also in carcinomas, elaborate complexes of attached crypts (connected crypt structures) were characteristic of the Middle zone, so that proximate zone was always architecturally simpler. We conclude, that despite continuous carcinoma growth, the invaded border mucosa maintains a prototypical zonal organization of molecular and histological crypt changes This spatially organized reaction pattern is likely to reflect an interplay between regulated growth and destructive processes in response to advancing carcinoma. Compared to the edges of benign colonic tumors, the edges of carcinomas are distinctive and consistent enough to be diagnostically useful.

Adenocarcinoma↗

PubMed1999

Three years of clinical evaluation of endodontically treated teeth by 15 F CO2 laser microprobe: in vivo study.

OBJECTIVE: Evaluation of the efficiency of 15 F CO2 laser microprobe, in cases of periapical lesions. The elimination of the pathological reaction caused by certain species of bacteria by reduction of reinfection and stimulation of osteogenesis. SUMMARY BACKGROUND DATA: Until now, no suitable delivery fiber existed for CO2 laser endodontic radiation in the apical region where it is most difficult to eliminate the pulp tissue using conventional methods. To overcome this problem, Sharplan Lasers designed a microprobe that reaches closer to the apex, distributing the energy density to a smaller area of the root canal, thus favorably increasing the thermal effects. METHODS: The study was conducted on 900 teeth, corresponding to 1512 root canals, divided in two groups. Four hundred sixty-eight were new cases, carefully selected according to strict parameters such as wide periapical translucency over 1 mm, supported by digital x-ray, with a lesion of 3 mm and more. All root canals were mechanically prepared in the conventional method up to size 35, Physiological saline solution served as rinsing solution and the root canals were treated by 15 F CO2 laser microprobe for 60 pulses repeatedly. The temperature at the surrounding tissue of the root did not exceed 38 degrees C. RESULTS: Filling of the canal was possible at the same appointment, without antibiotic treatment. Four hundred thirty-two of the cases, which were referred to us by other dentists after an unsuccessful treatment according to the classic therapy, were treated by the same laser therapy. Follow-up was performed by clinical examination, and a digital x-ray was taken, during and after treatment as well as after 3, 6, 9, and 12 months. CONCLUSIONS: There is a 98% success rate in both study groups, according to objective criteria for successful treatment including reduction of apical translucency after 2-6 months, freedom from clinical complaints, and no need for periapical surgery.

Humans↗

PubMed1999

1,25-Dihydroxyvitamin D3 increases the growth-promoting activity of autocrine epidermal growth factor receptor ligands in keratinocytes.

Topical treatment of normal skin with 1,25-dihydroxyvitamin D3 [1,25-(OH)2D3] or its synthetic analogs results in enhanced keratinocyte proliferation. Autocrine growth factors belonging to the epidermal growth factor (EGF) family play a major role in controlling keratinocyte proliferation. 1,25-(OH)2D3 enhanced the autonomous proliferation of HaCaT human keratinocytes in the absence of exogenous growth factors. Autonomous and 1,25-(OH)2D3-stimulated proliferations were inhibited by a specific inhibitor of EGF receptor (EGFR) tyrosine kinase, an EGFR-neutralizing antibody, heparin, the heparin antagonist hexadimethrine, and the proteoglycan sulfation inhibitor chlorate. These results indicate the involvement of proteoglycan-dependent EGFR ligands. The initial events in EGFR (i.e. ErbB1) mitogenic signal transduction are dimer formation with another ErbB protein and tyrosine cross-phosphorylation. By immunoprecipitation followed by Western blotting we showed that ErbB1/ErbB3 heterodimers are the major mitogenic signaling entity in 1,25-(OH)2D3-stimulated cells. 1,25-(OH)2D3 did not affect the levels of the proteoglycan-dependent EGFR ligands amphiregulin and heparin-binding EGF nor the synthesis of proteoglycans, as assessed by 35S labeling and ion exchange chromatography. 1,25-(OH)2D3 caused a marked increase in the cellular contents of ErbB1, ErbB2, and ErbB3 proteins. The increase in ErbB proteins that mediates signal transduction by EGFR ligands can account for the stimulatory effect of 1,25-(OH)2D3 on autonomous keratinocyte proliferation.

Autocrine Communication↗

PubMed1999

Double-phase 99mTc-sestamibi scintimammography and trans-scan in diagnosing breast cancer.

UNLABELLED: The goal of our study was to assess the value of both scintimammography with 99mTc-sestamibi (SMM) and trans-scan (T-scan) in detecting breast cancer. METHODS: A total of 121 women were evaluated by palpation, mammography, SMM and T-scan. SMM was performed in the prone, breast dependent position. Immediate and delayed views (double-phase) were obtained. T-scan is a new breast imaging method that maps noninvasively the distribution of tissue electrical impedance and capacitance. RESULTS: SMM had 88.9% sensitivity, 88.4% specificity and 88.4% accuracy in detecting breast cancer. SMM had 100% sensitivity in detecting breast tumors >1 cm and only 66% sensitivity in detecting tumors <1 cm. T-scan had 72.2% sensitivity and 67% specificity in detecting breast cancer. It detected one more breast cancer than SMM, at the expense of 27 additional false-positive results. CONCLUSION: Double-phase SMM was sensitive and specific in detecting breast cancer. This method may reduce the rate of negative breast biopsies in tumors >1 cm. T-scan was only moderately accurate in detecting breast cancer. Its addition to SMM did not improve significantly the rate of breast cancer detection. However, because of its complete noninvasiveness, large-scale applicability and low cost, T-scan deserves further refining.

Adult↗

PubMed1998

1,25-Dihydroxyvitamin D3 enhances degranulation of mast cells.

The mast cell lines rat basophilic leukemia (RBL) and mouse C57 cells respond to IgE/antigen complexes by degranulation. Treatment of these cells with 1,25-dihydroxyvitamin D3 (1,25(OH)2D3), (10-100 nM) for 24-48 h enhanced IgE/antigen-induced exocytosis as monitored by release of hexosaminidase. A short term incubation with the hormone did not affect exocytosis, ruling out a rapid non genomic mechanism. The presence of vitamin D receptors, demonstrated by immunoblotting and the lack of effect of 24,25(OH)2D3 suggest a role for these receptors in the enhancing effect. 1,25(OH)2D3 also enhanced exocytosis induced by the calcium ionophore A23187 in the presence or absence of phorbol ester indicating modulation of events distal to signal transduction. 1,25(OH)2D3 enhanced exocytosis in the presence of cytochalasin D, indicating that the action of the hormone is not due to effects on microfilament structure. The results of this study suggest that 1,25(OH)2D3 may affect the allergic or pro-inflammatory potential of mast cells.

Animals↗

PubMed1998

Leiomyoma of the urinary bladder.

Leiomyoma of the urinary bladder is a rarity but should be considered in the differential diagnosis of intramural neoplasm. We report a case illustrating clinical and pathological features in particular the immunohistochemistry. Etiology and differential diagnosis are discussed.

Diagnosis, Differential↗

PubMed1998

Giant splenomegaly caused by splenic metastases of melanoma.

Splenic metastases are rare and usually occur in the setting of widespread visceral metastases. Splenomegaly as manifestation of metastatic spread is extremely rare. A patient with melanoma and metastases to the skin and lung is described. He developed a giant painful splenomegaly. The splenectomy specimen demonstrated that the spleen was occupied by metastases from the melanoma. Metastases of melanoma may cause extreme enlargement of the spleen. If the patient's general condition is good, splenectomy is indicated in order to prevent spontaneous rupture of the spleen.

Aged↗

PubMed1998

Upregulation of the calcium-dependent protease, calpain, during keratinocyte differentiation.

Calpain is a ubiquitous neutral calcium-activated thiol protease that is implicated in various cellular functions including exocytosis, cell fusion, apoptosis and proliferation. The calpain system is composed of the enzymes mu-calpain and m-calpain and their endogenous inhibitor, calpastatin. We employed the spontaneously immortalized human HaCaT keratinocytes, which retain their ability to differentiate in vitro and in vivo, to study the modulation of the calpain system during keratinocyte differentiation. The cellular levels of keratinocyte differentiation markers and of the components of the calpain system were monitored by immunoblotting. Three established differentiation stimuli: increase in cell density as a function of time in culture, elevation of extracellular calcium concentration and exposure to 1,25-dihydroxyvitamin D3 enhanced the expression of the three keratinocyte differentiation markers keratin 10, involucrin and transglutaminase. The differentiation of HaCaT cells was accompanied by elevation of the components of the calpain system, although the pattern of increase varied according to the specific differentiation stimulus. A higher increase in calpains as compared with the increase in calpastatin suggests an increase in net calpain activity during differentiation. Such an increase may play a part in the differentiation process itself and/or in the regulation of key events in differentiating keratinocyte metabolism.

Calpain↗

PubMed1998

Histological changes induced by CO2 laser microprobe specially designed for root canal sterilization: in vivo study.

OBJECTIVE: Until now, no suitable delivery fiber has existed for CO2 laser endodontic radiation in the apical region, where it is most difficult to eliminate the pulp tissue using conventional methods. To overcome this problem, we have designed a microprobe that reaches closer to the apex, distributing the energy density to a smaller area of the root canal and thus favorably increasing the thermal effects. METHODS: A CO2 laser microprobe coupled onto a special hand piece was attached to the delivery fiber of a Sharplan 15-F CO2 laser. The study was conducted on 30 vital maxillary or mandibulary, central, lateral, or premolar teeth destined for extraction due to periodontal problems. Twenty were experimentally treated with pulsed CO2 laser delivered by this newly developed fiber after conventional root canal preparation. Temperature measured at three points on the root surface during laser treatment did not exceed 38 degrees C. Ten teeth represented the control group, in which only root canal preparation was performed in the conventional method. RESULTS: Histological examination of the laser-treated teeth showed coagulation necrosis and vacuolization of the remaining pulp tissue in the root canal periphery. Primary and secondary dentin appeared normal in all cases treated with 15-F CO2 laser. Gram stain and bacteriologic examination revealed complete sterilization. These results demonstrate the unique capabilities of this special microprobe in sterilization of the root canal, with no thermal damage to the surrounding tissue. CONCLUSIONS: The combination of classical root canal preparation with CO2 laser irradiation using this special microprobe before closing the canal can drastically change the quality of root canal fillings.

Bacteriological Techniques↗

PubMed1998

Diagnostic value of AgNOR staining in thyroid cytology.

OBJECTIVE: To determine the value of the argyrophil nucleolar organizer region (AgNOR) technique on scrape cytology of thyroid lesions. STUDY DESIGN: AgNOR counts were evaluated in smears of 70 thyroid lesions that were sent for frozen section and included 15 cases of follicular adenoma, 10 cases of follicular carcinoma, 13 cases of papillary carcinoma, 23 cases of nodular goiter and 9 cases of Hashimoto's thyroiditis. Forty-one slides out of 70 were freshly prepared, and 29 slides had been previously stained with hematoxylin and eosin and then destained with alcohol. The number of AgNOR dots was recorded for 50 cells, and the mean number was calculated. RESULTS: The mean AgNOR counts were statistically significantly higher in malignant lesions in comparison to benign lesions. CONCLUSION: AgNOR staining could be of use in cytologic material from thyroid lesions.

Adenocarcinoma, Follicular↗

PubMed1997

Lymph node-revealing solution: simple new method for detecting minute lymph nodes in colon carcinoma.

PURPOSE: Detection of metastatic lymph nodes in colon cancer is essential for determining stage and, thus, therapeutic modalities. However, very small lymph nodes can easily be missed during routine examination. The aim of this study is to describe a new and easy technique for detecting tiny nodes in colonic specimens. METHODS: Thirty problematic cases, in which an unsatisfactory number of lymph nodes was found by the traditional method, were investigated. The entire mesocolonic fat was immersed for six hours in a lymph node-revealing solution (LNRS) composed of various traditional fixatives and fatty solvents. After six hours, the lymph nodes stood out as white, chalky nodules on the background of yellow fat. They were then excised, processed. and stained. RESULTS: Total number of lymph nodes found by the traditional method in the 30 cases was 88. After LNRS, 258 additional lymph nodes, measuring from 0.5 to 7 mm in largest diameter, were found. Of the 12 cases in which no lymph nodes were found by the traditional method, 8 became N0 and 4 became N1. Of the 14 cases first classified as N0, 4 became N1; of the 4 classified at first as N1, 2 became N2 after LNRS. Upstaging from Dukes B to C occurred in eight cases. Quality of the sections and histochemical and immunohistochemical stains after LNRS was similar to that of formalin-fixed tissues. CONCLUSIONS: LNRS is an easy, rapid, and inexpensive technique for detecting very small lymph nodes. These may contain metastases, a fact that changes the stage of disease and influences the mode of therapy.

Acetic Acid↗

PubMed1997

Comparative study of the early postoperative course and complications in patients undergoing Billroth I and Billroth II gastrectomy.

Distal gastric resection can be followed by reconstruction according to the Billroth I (BI) or Billroth II (BII) techniques. The aim of this study was to compare the early postoperative results and complications of patients undergoing BI and those undergoing BII resection. Eighty-eight patients operated during the years 1991 to 1994 underwent distal gastric resection (41 had BI, and 43 had BII resections). The indications for BI resections were gastric tumors in 39 patients (95%) and duodenal ulcer in 2 (5%). The indications for BII resection were malignancy in 28 patients (65%) and duodenal ulcer disease in 15 (35%). The average duration of the procedure was 147 +/- 28 minutes for the BI resection and 175 +/- 38 minutes for the BII resection (p < 0.05). No patient in the BI group developed anastomic leakage. Two patients who underwent BII resection developed duodenal stump leakage (4.7%). Relaparotomy was indicated in five patients, two from the BI group (malignant cells in the resection margins) and three from the BII group (one due to duodenal stump leakage and two for bleeding). There was no postoperative mortality in the BI group. The postoperative mortality in the BII group was 7.1% (p < 0.05). The average proximal gastric resection margins were significantly smaller in the BI group than in the BII group (3.65 +/- 2.83 cm and 5.18 +/- 2.57 cm, respectively; p < 0. 05). The number of lymph nodes found in the resected specimen did not differ significantly between the two groups. Recurrent tumor at the gastric remnant developed in two patients in the BI group but not in the BII group. The results of our study revealed that the BI procedure is accompanied by significantly lower postoperative complication and mortality rates than the BII procedure in cases of gastric malignancy. BI resection performed for malignancy seems to achieve smaller proximal gastric resection margins, which may influence the recurrence rate.

Adenocarcinoma↗

PubMed1997

1,25-dihydroxyvitamin D3 and agents that increase intracellular adenosine 3',5'-monophosphate synergistically inhibit fibroblast proliferation.

Agents that increase intracellular cAMP (cAMP elevating agents) and 1, 25(OH)2D3 inhibit the proliferation of many cell types. We investigated the combined effect of 1,25(OH)2D3 and cAMP elevating agents on exponentially growing mouse 3T3 fibroblasts. The following cAMP elevating agents were used: theophylline and pentoxyfilline, which inhibit cAMP-dependent phosphodiesterase; prostaglandin E2 which activates adenylate cyclase by a receptor-mediated mechanism; forskolin, which directly stimulates adenylate cyclase; and the cell permeable cAMP analogs 8-bromo cAMP and N6 benzoyl cAMP. 1,25(OH)2D3 and cAMP elevating agents were added to exponentially growing fibroblasts cultured in 96-well microtiter plates and cell number was monitored 3-7 d later. 1,25(OH)2D3 and the cAMP elevating agents as single agents inhibited the growth of the 3T3 cells. The combined treatment of the fibroblasts with 1,25(OH)2D3 and the cAMP elevating agents resulted in an antiproliferative effect that was more than additive. The synergistic interaction depended on the dose of 1,25(OH)2D3 and was apparent already at 10(-8) M of the hormone. The specificity of the effect of 1,25(OH)2D3 was demonstrated by the finding that 24,25-dihydroxyvitamin D3, a vitamin D metabolite with low affinity for the vitamin D receptor, did not affect the antiproliferative effect of cAMP elevating agents. From the synergistic interaction between 1,25(OH)2D3 and the cell permeable cAMP analogs, we infer that the site of interaction between the two signaling pathways is distal to the cAMP generating and degrading machinery.

24,25-Dihydroxyvitamin D 3↗

PubMed1997

The clinical and histological features of transitional cell carcinoma of the bladder with microcysts: analysis of 12 cases.

OBJECTIVE: To describe the clinical course and histological features of transitional cell carcinoma (TCC) of the bladder with microcysts. PATIENTS AND METHODS: Among 940 patients with bladder TCC diagnosed at our institution during a 5 year period. 12 (1.2%; eight men and four women, mean age 71.1 years, range 52-85) were diagnosed histologically as having microcystic TCC. Sections of the tumours were stained with haematoxylin and eosin, periodic acid-Schiff and Alcian blue and clinical data obtained from the patients' records. RESULTS: Of the 12 patients with bladder TCC with microcysts, three had tumours confined to the epithelium, six had tumour invasion of the lamina propria and three had muscle invasion. One patient had low-grade TCC and 11 had high-grade TCC; six patients had a second primary tumour; three had a colon carcinoma, one a villous adenoma of the caecum, one a locally advanced carcinoma of the prostate and the last a squamous cell carcinoma of the uterine cervix. CONCLUSIONS: Microcystic TCC was associated with high-stage and high-grade bladder tumours and with other primary tumours, especially of the colon. Screening these patients for asymptomatic tumours of the colon is suggested.

Aged↗

PubMed1997

Lymph-node revealing solution: a new method for detecting minute lymph nodes in cystectomy specimens.

OBJECTIVE: To describe the use of a new lymph-node revealing solution (LNRS) for detecting lymph node involvement in total cystectomy specimens from patients with locally confined invasive transitional cell carcinoma (TCC) of the bladder, and to compare the results obtained with those using the conventional method (palpation and sectioning perivesical fat) that may fail to detect very small lymph nodes. MATERIALS AND METHODS: Of 12 cystectomy specimens obtained from patients with TCC, six in which 0-3 metastatic nodes were identified by the conventional method were further investigated using LNRS. The revealing solution comprised 95% ethanol, diethyl ether, glacial acetic acid and buffered formalin (65:20:5:10 v/v) prepared under a fume-hood. After evaluation using the conventional method, the specimens were immersed for 6-12 h in the solution, washed under running tap water and the adipose tissue sectioned at intervals of 2-3 mm. Lymph nodes were identified as white, chalky nodules against the background of yellow fat. The number of the lymph nodes identified by conventional and the LNRS methods was recorded and classified according the TNM system. RESULT: Twenty-two lymph nodes were detected by the conventional method, of which four were positive for tumour metastasis. Using the LNRS, an additional 21 nodes were identified among which 12 were positive. The mean size of the lymph nodes detected by the conventional and LNRS methods was 7.96 mm and 3.81 mm, respectively. The stage of three patients was increased (Nx to N2, N0 to N2 and N1 to N2) and therefore two of these patients received adjuvant chemotherapy. CONCLUSIONS: LNRS significantly enhanced the yield of normal and metastatic nodes of cystectomy specimens and may identify smaller nodes. The LNRS method allows a more accurate staging with better assessment of the prognosis and need for adjuvant therapy.

Carcinoma, Transitional Cell↗

PubMed1997

Lymph node revealing solution: a new method for detection of minute axillary lymph nodes in breast cancer specimens.

The staging and prognosis of patients with breast cancer is related to the presence or absence of axillary lymph node involvement. However, in some cases no lymph nodes or too small a number of lymph nodes are revealed by the traditional method of palpating and sectioning the axillary fat. In the present study we demonstrate the usefulness of the lymph node revealing solution (LNRS) in breast cancer. Specimens from 13 patients, in whom <10 lymph nodes were identified in the axilla by the traditional method, were included in the study. After excising the lymph nodes by the traditional method, axillary tissue was immersed in LNRS for 6-12 hours. Additional lymph nodes, which stood out as white chalky nodules, were excised and processed as usual. The LNRS increased the mean number of nodes per case from 6.0+/-2.5 found by the traditional method to 12.54+/-4.61 nodes per case (p < 0.01). The size of the nodes identified by the LNRS was significantly smaller (p < 0.01) than those detected by the traditional method. The LNRS changed the lymph node stage of the disease in four of the studied cases (30%). LNRS seems to be the technique of choice for detection of axillary lymph nodes in cases where the number of detected lymph nodes by the traditional method is too small for accurate staging.

Axilla↗

PubMed1997

Safety and immunogenicity of a novel mammalian cell-derived recombinant hepatitis B vaccine containing Pre-S1 and Pre-S2 antigens in neonates.

BACKGROUND: Most of the licensed hepatitis B vaccines produced by recombinant DNA contain the S protein component of the hepatitis B virus surface antigen particle but lack two important components, Pre-S1 and Pre-S2. These components have recently been shown to play an important immunogenic role by enhancing the hepatitis B surface antibody (anti-HBs) titers, stimulating response and circumventing genetic nonresponsiveness. OBJECTIVE: To assess safety, tolerability and immunogenicity in neonates of a novel recombinant HBV vaccine (Bio-Hep-B) containing the S, Pre-S1 and Pre-S2 components compared with a licensed recombinant vaccine (Engerix-B) containing the S component only. METHODS: Healthy neonates were randomized to receive either Bio-Hep-B (2.5 micrograms/dose) or Engerix-B (10 micrograms/dose) at ages < 24 h, 1 month and 6 months. Blood was obtained at ages 0, 1, 7 and 12 months. Tolerability was assessed by diary cards filled by the parents for 5 successive days after immunization. Immunogenicity was assessed by determination of anti-HBs antibody. RESULTS: Of 205 neonates 153 were in the Bio-Hep-B group and 52 were in the Engerix-B group. Both vaccines were well-tolerated and all infants became seroprotected (anti-HBs > 10 mIU/ml). After the first dose a significantly higher proportion of neonates seroconverted in the Bio-Hep-B group than in the Engerix-B group (83% vs. 34%; P < 0.001); this difference in seroresponse was even more pronounced for those achieving seroprotective concentrations (> 10.0 mIU/ml) after the first dose: 54% vs. 7%, respectively (P < 0.001). Geometric mean concentrations were significantly higher at all points in the Bio-Hep-B group. CONCLUSION: Both vaccines were well-tolerated and immunogenic. Bio-Hep-B, despite its low dose, was significantly more immunogenic and elicited more rapid antibody response. This finding has implication for future vaccine programs in regions where maternal screening for hepatitis B virus surface antigen and administration of hepatitis B immunoglobulin are not routinely practiced at birth for infants of hepatitis B virus carrier mothers.

Female↗

PubMed1996

Safety and immunogenicity of a novel mammalian cell-derived recombinant hepatitis B vaccine containing Pre-S1 and Pre-S2 antigens in children.

We tested the safety and immunogenicity of the new recombinant hepatitis B virus (HBV) vaccine produced via expression of the Pre-S1, Pre-S2 and S protein components of the hepatitis B surface antigen (HBsAg). A reduced dose (2.5 micrograms) of the vaccine (Bio-Hep-B) was tested in children aged 4-9 years and was compared to a 10 microgram dose of a licensed vaccine (Engerix-B) in a randomized manner. Both vaccines were administered in 3 doses (0, 1 and 6 month intervals). Adverse events were collected 5 days following each vaccination by a diary card provided to the parents. Immunogenicity was tested by measuring anti-hepatitis B surface antibody (anti-HBs). A total of 217 children were enrolled (162 in the Bio-Hep-B group and 55 in the Engerix-B group). Total adverse events were observed in 35% of the Bio-Hep-B group and 33% of the Engerix-B group, with no differences when each of the potential adverse events was considered. Titers were within the expected range (geometric mean titers post dose 1, 2 and 3 were 45.8, 8360.2 and 1445.7, respectively, for Bio-Hep-B and 36.3, 10316.1 and 1898.7, respectively, for Engerix-B). A trend toward better immunogenicity with Bio-Hep-B was observed at early visits when measured by both seroconversion (anti-HBs > or = 2.1 mIU ml-1) rate and seroprotection (anti-HBs > or = 10 mIU ml-1) rate; however, statistical significance was not reached. We conclude that in children, Bio-Hep-B vaccine at a reduced dose was as safe and as immunogenic as Engerix-B given at the regular pediatric dosage.

Child↗