• Pediatric Infection and Vaccine
• /
• v.10 no.1
• /
• pp.71-80
• /
• 2003

Purpose : Four kinds of Haemophilus influenzae type b protein conjugate vaccines, PRPD, PRP-T, PRP-OMP and PRP-CRM197, have been developed, and PRP-T vaccines are currently produced by two manufacturer, $ActHib^{(R)}$ by Aventis and $Hiberix^{TM}$ by GlaxoSmith-Kline Biologicals. The purpose of this study is to evaluate the immunogenicity and safety of $Hiberix^{TM}$ in Korean infants. Methods : Seventy-three healthy infants(43 male infants) were recruited for this study after parental informed consent was obtained. Each infant was vaccinated at 2, 4 and 6 months of age with the study vaccine. At each visit, infants were also immunized with DTaP, trivalent oral polio vaccine and hepatitis B vaccine when indicated. The serum anti-PRP antibody was measured at prevaccination, 2 month later after the 2nd dose, and 1 month later after the 3rd dose by the ELISA method. The local and systemic adverse reactions of vaccination were monitored for 3 consecutive days after each immunization. Immunogenicity of vaccine was evaluated in infants who received all the scheduled immunization and the adverse reactions were evaluated for infants who received at least one dose of the study vaccine. Results : Among seventy three infants, enrolled in this study; sixty three(37 male infants) completed all the scheduled immunizations. The geometric mean titer(GMT) of anti-PRP antibodies at prevaccination was 0.17 ${\mu}g/mL$(95% confidence interval[CI]; 0.13~0.22). The GMT of anti-PRP antibodies increased to 4.14 ${\mu}g/mL$(95% CI; 2.65~6.48) at 2 month later after the 2nd dose of PRP-T and 14.65 ${\mu}g/mL$(95% CI; 10.83~19.81) at 1 month later after the 3rd dose. Anti-PRP antibody ${\geq}0.15$ ${\mu}g/mL$, was observed in 98.4%(95% CI; 91.8~100) after 2 doses and 100%(95% CI; 100~100) after 3 doses. Anti-PRP antibody ${\geq}1.0$ ${\mu}g/mL$, was obtained in 77.8%(95% CI; 67.5~88.0) after 2 doses, and 98.4%(95% CI; 95.3~100) after 3 doses. Most of the adverse reaction after vaccination were mild. Irritability, the most common systemic reaction, was observed in 45.5%, followed by drowsiness(30.5%), poor feeding(26.7%) and fever(5.6%). Among the local reactions tenderness was observed in 7.9%, redness(${\geq}5$ mm) in 2.8% and swelling(${\geq}5$ mm) in 1.8%. Conclusion : The PRP-T vaccine used in this study was highly immunogenic and safe in Korean young infants. The finding that high GMT and high frequency of infants with a protective titer achieved after 2 doses is consistent with the previous studies which were done with a PRP-T vaccine of other manufacturer. This study suggests that the immunization schedule of PRP-T vaccine for Korean infants may need re-evaluation.

• Pediatric Infection and Vaccine
• /
• v.13 no.2
• /
• pp.163-173
• /
• 2006

Purpose : To reduce the number of injections necessary to vaccinate young infants, various combined vaccines have been developed. The $Comvax^{TM}$ manufactured by Merck & Co. is a combination of Hepatitis B and PRP-OMP conjugate Haemophilus influenzae Type b vaccine. The purpose of this study is to evaluate the immunogenicity and safety of $Comvax^{TM}$ in Korean infants. Methods : The infants who were vaccinated at 0 months of age with Hepatitis B vaccine, were recruited for this study after parental informed consent was obtained. The subjects were vaccinated with $Comvax^{TM}$ at 2 and 4 months of age. At each visit, infants were also immunized with DTaP, inactivated poliovirus vaccine, and pneumococcal vaccine when indicated. The serum anti-PRP and anti-HBs were measured at 2 months after the 1st dose(4 months age), and the 2nd dose(6 months age) by the ELISA and chemiluminescent microparticle immunoassay method, respectively. The local and systemic adverse reactions of vaccination were monitored for 3 consecutive days after each immunization. Results : Among sixty-five healthy infants(35 male infants) enrolled in this study; fifty eight(32 male infants) completed the scheduled immunizations. The geometric mean titers (GMTs) of anti-PRP at 2 months after the 1st dose and the 2nd dose were 1.96 ${\mu}g/mL$ (95% CI; 1.38~2.78) and 10.02 ${\mu}g/mL$ (95% CI; 7.04~14.26), respectively. Anti-PRP ${\geq}1.0$ ${\mu}g/mL$, was obtained in 63.2%(95% CI; 53.75~72.65) after 1 dose, and 96.6%(95% CI; 93.05~100) after 2 doses. The GMTs of anti-HBs were 38.32 mIU/mL(95% CI; 22.42~65.51), and 101.17 mIU/mL(95% CI; 65.94~155.25) at 2 month after the 1st dose and 2nd dose of $Comvax^{TM}$, respectively. Anti-HBs ${\geq}10$ mIU/mL was observed in 73.7%(95% CI; 65.07~82.33) after 1 dose and 94.8%(95% CI; 90.45~99.15) after 2 doses. Most of the adverse reactions after vaccination were mild. Irritability, the most common systemic reaction, was observed in 24.8%, followed by drowsiness(19.2%), poor feeding(19.2%) and fever(7.2%). Among the local reactions tenderness was observed in 25.6%, redness(${\geq}5$ mm) in 19.2% and swelling(${\geq}5$ mm) in 4.8%. Conclusion : The $Comvax^{TM}$ vaccine was highly immunogenic for PRP and safe in Korean infants. Although the hepatitis B vaccine component was administered at 0, 2, 4 months, this study showed good immunogenicity against HBsAg.

• Tuberculosis and Respiratory Diseases
• /
• v.54 no.4
• /
• pp.415-428
• /
• 2003

Background : This study assessed the efficacy and toxicity of etoposide and carboplatin(EC) combination regimen as a first line therapy for small cell lung cancer(SCLC), and determined the efficacy and toxicity of topotecan for relapsed SCLC. Methods : One hundred and ten patients with previously untreated SCLC received etoposide($100mg/m^2$ i.v., day 1 to 3) and carboplatin($300mg/m^2$ i.v., day 1) combination chemotherapy every 3 weeks. For patients with relapsed SCLC after EC therapy, topotecan($1.5mg/m^2$) was administered for 5 consecutive days every 3 weeks. Response rate, survival and toxicity profiles were assessed. Response was recorded as CR(complete remission), PR(partial remission), SD(stable disease) and PD(progressive disease). Results : One hundred and one patients were assessed for response to EC. Overall response rate to EC was 57.4%(CR 15.8%, PR 41.6%) with a time to progression of 10.3 months(median). The toxicity was tolerable and there was no treatment-related death. Twenty one relapsed SCLC patients were treated with topotecan. Of those who relapsed within 3 months of EC(refractory relapse, RR), 15.4%(2/13) showed PR, while of those who relapsed after 3 months(sensitive relapse, SR), 25%(2/8) exhibited PR. Grade 4 neutropenia was noted in 9.5% and 14.3% showed thrombocytopenia(G4). Conclusion : The EC regimen showed a moderate response rate for SCLC with minimal toxicity. The use of topotecan for relapsed SCLC warrants further investigation.

• Proceedings of the KOR-BRONCHOESO Conference
• /
• 1972.03a
• /
• pp.6-7
• /
• 1972

The air pollutants can be classified into the irritant gas and the asphixation gas, and the irritant gas is closely related to the otorhinolaryngological diseases. The common irritant gases are nitrogen oxides, sulfur oxides, hydrogen carbon compounds, and the potent and irritating PAN (peroxy acyl nitrate) which is secondarily liberated from photosynthesis. Those gases adhers to the mucous membrane to result in ulceration and secondary infection due to their potent oxidizing power. 1. Sulfur dioxide gas Sulfur dioxide gas has the typical characteristics of the air pollutants. Because of its high solubility it gets easily absorbed in the respiratory tract, when the symptoms and signs by irritation become manifested initially and later the resistance in the respiratory tract brings central about pulmonary edema and respiratory paralysis of origin. Chronic exposure to the gas leads to rhinitis, pharyngitis, laryngitis, and olfactory or gustatory disturbances. 2. Carbon monoxide Toxicity of carbon monoxide is due to its deprivation of the oxygen carrying capacity of the hemoglobin. The degree of the carbon monoxide intoxication varies according to its concentration and the duration of inhalation. It starts with headache, vertigo, nausea, vomiting and tinnitus, which can progress to respiratory difficulty, muscular laxity, syncope, and coma leading to death. 3. Nitrogen dioxide Nitrogen dioxide causes respiratory disturbances by formation of methemoglobin. In acute poisoning, it can cause pulmonary congestion, pulmonary edema, bronchitis, and pneumonia due to its strong irritation on the eyes and the nose. In chronic poisoning, it causes chronic pulmonary fibrosis and pulmonary edema. 4. Ozone It has offending irritating odor, and causes dryness of na sopharyngolaryngeal mucosa, headache and depressed pulmonary function which may eventually lead to pulmonary congestion or edema. 5. Smog The most outstanding incident of the smog occurred in London from December 5 through 8, 1952, because of which the mortality of the respiratory diseases increased fourfold. The smog was thought to be due to the smoke produced by incomplete combustion and its byproduct the sulfur oxides, and the dust was thought to play the secondary role. In new sense, hazardous is the photochemical smog which is produced by combination of light energy and the hydrocarbons and oxidant in the air. The Yonsei University Institute for Environmental :pollution Research launched a project to determine the relationship between the pollution and the medical, ophthalmological and rhinopharyngological disorders. The students (469) of the "S" Technical School in the most heavily polluted area in Pusan (Uham Dong district) were compared with those (345) of "K" High School in the less polluted area. The investigated group had those with subjective symptoms twice as much as the control group, 22.6% (106) in investigated group and 11.3% (39) in the control group. Among those symptomatic students of the investigated group. There were 29 with respiratory symptoms (29%), 22 with eye symptoms (21%), 50 with stuffy nose and rhinorrhea (47%), and 5 with sore thorat (5%), which revealed that more than half the students (52%) had subjective symptoms of the rhinopharyngological aspects. Physical examination revealed that the investigated group had more number of students with signs than those of the control group by 10%, 180 (38.4%) versus 99 (28.8%). Among the preceding 180 students of the investigated group, there were 8 with eye diseases (44%), 1 with respiratory disease (0.6%), 97 with rhinitis (54%), and 74 with pharyngotonsillitis (41%) which means that 95% of them had rharygoical diseases. The preceding data revealed that the otolaryngological diseases are conspicuously outnumbered in the heavily polluted area, and that there must be very close relationship between the air pollution and the otolaryngological diseases, and the anti-pollution measure is urgently needed.