AIM:The study was initiated to evaluate the reactogenicity and immunogenicity of a recombinant hepatitis B vaccine in age group >40 years and to study the response of a single booster dose in primary non-responders...AIM:The study was initiated to evaluate the reactogenicity and immunogenicity of a recombinant hepatitis B vaccine in age group >40 years and to study the response of a single booster dose in primary non-responders to the hepatitis B vaccination. METHODS:A total of 102 volunteers without markers of hepatitis B infection (negative for HBsAg,anti-HBc antibody, HBeAg and anti-HBs antibody) received 20μg of recombinant HB vaccine intramuscularly at 0,1,and 6 months.Anti HBs titers were evaluated by a quantitative Elisa kit at 90 and 210 days.A booster dose of 20μg HB vaccine was given after 6 months of the 3^(rd) vaccine dose to the 15 non- responders and anti-HBs titers were measured after i month. RESULTS:Seroprotection (anti-HBs GMT^3 10 IU/L) was achieved in 85.3 % (87/102) volunteers.The mean GMT titers of the vaccine responders was 136.1 IU/L.Of the seroprotected individuals,there were 32.4% (33/102) hyporesponders (anti- HBs titers <10-99 mIU/ml) and 52.9% (54/102) were responders (anti-HBs titers >100 IU/L).All the non-responders (15/15) responded to a single dose of the booster dose of recombinant HB vaccine and their mean anti-HBs antibody titers were more than 100.5 mIU/ml after the booster dose. CONCLUSION:Recombinant hepatitis B vaccine offers good seroprotection in the age group >40 years and has a good safety profile.A single booster dose after 6 months in primary non-responders leads to good seroprotective anti-HBs antibody titers.However,larger population based studies are needed to evaluate the role of a booster dose in selected group of non-responders and whether such an approach will be cost effective.展开更多
AIM： （1） To gain information on immune responses to an accelerated schedule of 0, 1, and 2 mo in paramedical staff and BDS students who are at an increased risk of getting hepatitis B infection and come under high ...AIM： （1） To gain information on immune responses to an accelerated schedule of 0, 1, and 2 mo in paramedical staff and BDS students who are at an increased risk of getting hepatitis B infection and come under high risk groups. （2） To assess the efficacy and safety of En/vac- HB in different age groups, using genetically modified yeast strain Pichia pastoris, a new recombinant hepatitis B accine developed and manufactured in India. METHODS： A prospective, comparative, and single blinded trial of rapid （0, 1, and 2 mo） hepatitis B immunization schedulewas reported. A total of three hundred and seven （212 females and 95 males） healthy volunteers divided into three age groups （18-29, 30-39, and 40-49） were enrolled after screening for markers of hepatitis B. All the volunteers received 20 mg of the vaccine intramuscularly at 0, 1, and 2 mo. RESULTS： Geometric mean titers were calculated pre and post vaccination. Before immunization the GMT was 0.0124 mIU/mL. One month after the administration of the third dose of recombinant vaccine 296/307 （96.5%） subjects achieved seroprotective levels of anti-HBs. The geometric mean anti-HBs titers achieved after one month of the third dose was 2 560.0 mIU/mL. The geometric mean anti-HBs titer of males was 2 029.0 mIU/mL, while that of the females was 2 759.0 mIU/mL. In the age group of 18-29 years, anti-HBs titer was 3 025.0 mIU/ mL, while that in the age group of 30-39 years was 2 096.0 mlU/mL. In third age group of 40-49 years, anti- HBs titer was 1 592.0 mIU/mL. Hyper-responses （anti-HBs≥100 mIU/mL） were shown in 88.0% （271/307） of subjects. Eleven （3.5%） subjects responded poorly to the vaccine in the age group of 40-49 years. There was only mild pain at the site of injection otherwise there were no other adverse drug reactions （ADRs）. CONCLUSION： This vaccine （Enivac-HB） is safe and efficacious, providing significant protection after the third dose and rapid hepatitis B immunization schedule of 0, 1, and 2 mo can be recommended whenever rapid protection is the goal.展开更多
An easy and rapid method for the α-bromination of ketones using N-bromosuccinimide （NBS） catalyzed by silica gel in methanol under reflux conditions was developed. The expected products were formed in excellent iso...An easy and rapid method for the α-bromination of ketones using N-bromosuccinimide （NBS） catalyzed by silica gel in methanol under reflux conditions was developed. The expected products were formed in excellent isolated yields within a short period of time （5-20 min）. Major advantages of the present procedure include use of inexpensive and readily available catalyst, exclusion of pre- and post-chemical treatment of catalyst and use of methanol as solvent instead of ethers and chlorinated solvents.展开更多
Medical device clinical trial is a preliminary clinical human safety and effectiveness evaluation test. With the rapid development of science and technology, the research and development of medical devices is increasi...Medical device clinical trial is a preliminary clinical human safety and effectiveness evaluation test. With the rapid development of science and technology, the research and development of medical devices is increasing year by year, so it is particularly important to improve the clinical research level of medical devices. Medical statistics is one of the effective means to ensure scientific and reasonable clinical trial design and reliable test results. SAS software is important software for statistical analysis of clinical trials of medical equipment. Starting from the specific application of SAS software, this paper focuses on correctly understanding and selecting various results of SAS statistics, and provides some practical experience for those who learn to apply SAS, so as to make the clinical statistics of medical devices possible. The trial is more accurate and scientific.展开更多
Present work evaluated the possible impact of choline on metabolic enzymes of cultured fish species into a semi-intensive pond culture system,reared with Catla catla(catla),Labeo rohita(rahu),Clarias batracus(magur)an...Present work evaluated the possible impact of choline on metabolic enzymes of cultured fish species into a semi-intensive pond culture system,reared with Catla catla(catla),Labeo rohita(rahu),Clarias batracus(magur)and Anabas testudineus(climbing perch)for 90 days in two seasons.Choline was added directly into the pond water periodically throughout the experimental tenure.The water quality parameters of each experimental pond were monitored and were analyzed in 15 days interval throughout the experimental tenure in both the seasons.Results were compared with treatment as choline-fed and control as non-choline-fed conditions during breeding(June-Aug.)and dry(Nov.-Jan.)seasons.The metabolic enzymes,viz.,LDH(Lactate dehydrogenase),MDH(Malate dehydrogenase),and G6PDH(Glucose-6-phosphate dehydrogenase)activities in the muscle,liver,and AchE(Acetylcholine esterase)activity in the brain and muscle revealed maximum significantly(p<0.01),but ALT(Alanine aminotransferase)and AST(Aspartate aminotransferase)activity showed significant(p<0.01)depletion in the muscle and liver in treatment-breeding(TB)condition.The fishes under treatment-dry(TD)condition presented significant(p<0.01)higher elevation in HK(Hexokinase)activity in the muscle and liver.Additionally,the result of principal component analysis(PCA)depicted the positive as well as in some cases a negative correlation among the enzymatic activities both in dry and breeding seasons.So,it can be inferred that choline enrichment in fishes can substantiate the well nutritionally balanced food-flesh for consumption under this farm culture and the choline behaved as a positive contaminant into the pond eco-system under the semi-intensive culture condition.展开更多
Recombinant HCGβ-LTB expressed in the yeast,holds a significant promise as a contraceptive vaccine for women.It induces bio-effective anti-hCG antibodies,which can potentially prevent pregnancy by neutralizing the hC...Recombinant HCGβ-LTB expressed in the yeast,holds a significant promise as a contraceptive vaccine for women.It induces bio-effective anti-hCG antibodies,which can potentially prevent pregnancy by neutralizing the hCG hormone crucial for establishment and maintenance of pregnancy.The vaccine produced in shake-flask culture and administered along with adjuvant Mycobacterium indicus pranii(MIP)induces high anti-hCG titres in mice of different genetic strains.This study aimed to produce the vaccine in high cell density culture in a bioreactor and assess its consistency and efficacy compared to shake-flask production.A fed-batch culture increased the cell biomass nearly 6.5 folds higher than the shake-flask culture.Increase in specific-activity by a factor of 1.7 resulted in almost 11-fold higher volumetric activity.Characterization of the purified protein and immunogenicity studies conducted in mice demonstrated that it was comparable to protein made in shake-flask.This study shows that hCGβ-LTB vaccine can be produced cost-effectively with consistent characteristics in high cell density cultures of Pichia pastoris on a large-scale for eventual pre-clinical/clinical studies.展开更多
文摘AIM:The study was initiated to evaluate the reactogenicity and immunogenicity of a recombinant hepatitis B vaccine in age group >40 years and to study the response of a single booster dose in primary non-responders to the hepatitis B vaccination. METHODS:A total of 102 volunteers without markers of hepatitis B infection (negative for HBsAg,anti-HBc antibody, HBeAg and anti-HBs antibody) received 20μg of recombinant HB vaccine intramuscularly at 0,1,and 6 months.Anti HBs titers were evaluated by a quantitative Elisa kit at 90 and 210 days.A booster dose of 20μg HB vaccine was given after 6 months of the 3^(rd) vaccine dose to the 15 non- responders and anti-HBs titers were measured after i month. RESULTS:Seroprotection (anti-HBs GMT^3 10 IU/L) was achieved in 85.3 % (87/102) volunteers.The mean GMT titers of the vaccine responders was 136.1 IU/L.Of the seroprotected individuals,there were 32.4% (33/102) hyporesponders (anti- HBs titers <10-99 mIU/ml) and 52.9% (54/102) were responders (anti-HBs titers >100 IU/L).All the non-responders (15/15) responded to a single dose of the booster dose of recombinant HB vaccine and their mean anti-HBs antibody titers were more than 100.5 mIU/ml after the booster dose. CONCLUSION:Recombinant hepatitis B vaccine offers good seroprotection in the age group >40 years and has a good safety profile.A single booster dose after 6 months in primary non-responders leads to good seroprotective anti-HBs antibody titers.However,larger population based studies are needed to evaluate the role of a booster dose in selected group of non-responders and whether such an approach will be cost effective.
基金Supported by the Panacea Biotec Limited, New Delhi 110044,India
文摘AIM： （1） To gain information on immune responses to an accelerated schedule of 0, 1, and 2 mo in paramedical staff and BDS students who are at an increased risk of getting hepatitis B infection and come under high risk groups. （2） To assess the efficacy and safety of En/vac- HB in different age groups, using genetically modified yeast strain Pichia pastoris, a new recombinant hepatitis B accine developed and manufactured in India. METHODS： A prospective, comparative, and single blinded trial of rapid （0, 1, and 2 mo） hepatitis B immunization schedulewas reported. A total of three hundred and seven （212 females and 95 males） healthy volunteers divided into three age groups （18-29, 30-39, and 40-49） were enrolled after screening for markers of hepatitis B. All the volunteers received 20 mg of the vaccine intramuscularly at 0, 1, and 2 mo. RESULTS： Geometric mean titers were calculated pre and post vaccination. Before immunization the GMT was 0.0124 mIU/mL. One month after the administration of the third dose of recombinant vaccine 296/307 （96.5%） subjects achieved seroprotective levels of anti-HBs. The geometric mean anti-HBs titers achieved after one month of the third dose was 2 560.0 mIU/mL. The geometric mean anti-HBs titer of males was 2 029.0 mIU/mL, while that of the females was 2 759.0 mIU/mL. In the age group of 18-29 years, anti-HBs titer was 3 025.0 mIU/ mL, while that in the age group of 30-39 years was 2 096.0 mlU/mL. In third age group of 40-49 years, anti- HBs titer was 1 592.0 mIU/mL. Hyper-responses （anti-HBs≥100 mIU/mL） were shown in 88.0% （271/307） of subjects. Eleven （3.5%） subjects responded poorly to the vaccine in the age group of 40-49 years. There was only mild pain at the site of injection otherwise there were no other adverse drug reactions （ADRs）. CONCLUSION： This vaccine （Enivac-HB） is safe and efficacious, providing significant protection after the third dose and rapid hepatitis B immunization schedule of 0, 1, and 2 mo can be recommended whenever rapid protection is the goal.
基金Council of Scientific and Industrial Research(CSIR),New Delhi,Government of India for thefinancial support under major research project(No.01(2391)/10/EMR-II)
文摘An easy and rapid method for the α-bromination of ketones using N-bromosuccinimide （NBS） catalyzed by silica gel in methanol under reflux conditions was developed. The expected products were formed in excellent isolated yields within a short period of time （5-20 min）. Major advantages of the present procedure include use of inexpensive and readily available catalyst, exclusion of pre- and post-chemical treatment of catalyst and use of methanol as solvent instead of ethers and chlorinated solvents.
文摘Medical device clinical trial is a preliminary clinical human safety and effectiveness evaluation test. With the rapid development of science and technology, the research and development of medical devices is increasing year by year, so it is particularly important to improve the clinical research level of medical devices. Medical statistics is one of the effective means to ensure scientific and reasonable clinical trial design and reliable test results. SAS software is important software for statistical analysis of clinical trials of medical equipment. Starting from the specific application of SAS software, this paper focuses on correctly understanding and selecting various results of SAS statistics, and provides some practical experience for those who learn to apply SAS, so as to make the clinical statistics of medical devices possible. The trial is more accurate and scientific.
文摘Present work evaluated the possible impact of choline on metabolic enzymes of cultured fish species into a semi-intensive pond culture system,reared with Catla catla(catla),Labeo rohita(rahu),Clarias batracus(magur)and Anabas testudineus(climbing perch)for 90 days in two seasons.Choline was added directly into the pond water periodically throughout the experimental tenure.The water quality parameters of each experimental pond were monitored and were analyzed in 15 days interval throughout the experimental tenure in both the seasons.Results were compared with treatment as choline-fed and control as non-choline-fed conditions during breeding(June-Aug.)and dry(Nov.-Jan.)seasons.The metabolic enzymes,viz.,LDH(Lactate dehydrogenase),MDH(Malate dehydrogenase),and G6PDH(Glucose-6-phosphate dehydrogenase)activities in the muscle,liver,and AchE(Acetylcholine esterase)activity in the brain and muscle revealed maximum significantly(p<0.01),but ALT(Alanine aminotransferase)and AST(Aspartate aminotransferase)activity showed significant(p<0.01)depletion in the muscle and liver in treatment-breeding(TB)condition.The fishes under treatment-dry(TD)condition presented significant(p<0.01)higher elevation in HK(Hexokinase)activity in the muscle and liver.Additionally,the result of principal component analysis(PCA)depicted the positive as well as in some cases a negative correlation among the enzymatic activities both in dry and breeding seasons.So,it can be inferred that choline enrichment in fishes can substantiate the well nutritionally balanced food-flesh for consumption under this farm culture and the choline behaved as a positive contaminant into the pond eco-system under the semi-intensive culture condition.
基金supported by the Indian Council of Medical Research vide grant number 5/10/17/2009RHN.
文摘Recombinant HCGβ-LTB expressed in the yeast,holds a significant promise as a contraceptive vaccine for women.It induces bio-effective anti-hCG antibodies,which can potentially prevent pregnancy by neutralizing the hCG hormone crucial for establishment and maintenance of pregnancy.The vaccine produced in shake-flask culture and administered along with adjuvant Mycobacterium indicus pranii(MIP)induces high anti-hCG titres in mice of different genetic strains.This study aimed to produce the vaccine in high cell density culture in a bioreactor and assess its consistency and efficacy compared to shake-flask production.A fed-batch culture increased the cell biomass nearly 6.5 folds higher than the shake-flask culture.Increase in specific-activity by a factor of 1.7 resulted in almost 11-fold higher volumetric activity.Characterization of the purified protein and immunogenicity studies conducted in mice demonstrated that it was comparable to protein made in shake-flask.This study shows that hCGβ-LTB vaccine can be produced cost-effectively with consistent characteristics in high cell density cultures of Pichia pastoris on a large-scale for eventual pre-clinical/clinical studies.
