Day :
Keynote Forum
Ashish Sahai
Serum Institute of India Pvt. Ltd, India
Keynote: Development of new purified vero cell rabies vaccine (Rabivax-S) at the Serum Institute of India Pvt.Ltd
Time : 11:30-12:30
Biography:
Ashish Sahai has over 29 years of rich experience in the Biotechnological industry and Research Institute. He has experience in Research and Development, Quality Control, Quality Assurance, Production of Vaccines. He has acquired experience in protein purification, molecular sieve chromatography, ion exchange chromatography, electrophoresis, affinity chromatography, polymerase chain reaction, hybridoma technology. He has specialization in downstream processing of viruses using affinity chromatography
Abstract:
Introduction: Rabies is a 100% vaccine-preventable disease. Rabies disease still causes human deaths in the endemic areas in Asia and Africa. A cheap, rabies vaccine for humans that could be used in mass vaccination campaigns would be a valuable weapon against rabies. Serum institute of India Pvt. Ltd. has developed a new purified vero cell inactivated and lyophilized rabies vaccine (Rabivax-S) which is now a WHO prequalified rabies vaccine.
Methodology, Theoretical Orientation & Findings: Large scale production of Vero ATCC CCL81 cells were seeded in cell cube system. Then cells are infected with Pitman Moore (PM 3218) strain of rabies virus. After 48-72 hrs, infected cells are washed. The multiple harvests are collected from one cell cube system and clarified by filtration. Clarified harvest is concentrated using tangential flow filtration system. Inactivation of rabies virus is done using beta-propiolactone (BPL). Next step of purification is done by affinity column chromatography in order to remove BSA and host cell DNA and diafiltration to remove high salt concentration. Purified rabies antigen is prepared by adding stabilizer to diafiltered antigen and finally filtered by 0.22 micron filtration and stored in ethyl vinyl acetate bags. A number of purified rabies antigen bags are blended to achieve set antigen content in final bulk. The liquid vaccine is filled in 1 ml USP type 1 clear and tubular vial and lyophilized. With the lyophilized vial of rabies vaccine 1.0 ml of sterile water for injection is supplied as a diluents.
Conclusion & Significance: Study gives well developed new purified vero cell rabies vaccine (Rabivax-S), following all the GMP requirements. Animal study has demonstrated no toxicity issue. We evaluated its safety, toxicity and immunogenicity in post-exposure prophylaxis in clinical trials by IM and ID routes. This vaccine is good option among the available modern WHO prequalified rabies vaccine. Filling, lyophilization and packaging of final product.
Keynote Forum
Yongliang Feng
Shanxi Medical University, China
Keynote: Long-term immune effects of different vaccination regimens for hepatitis B vaccine among patients receiving methadone maintenance treatment: Secondary analysis of a randomized clinical trial
Time : 13:30-14:30
Biography:
Yongliang Feng is an Associate Professor of Epidemiology from Shanxi Medical University, Taiyuan, China. He has been working in the field of epidemiology since 2005. He has been the Principal Investigator for 1 grants from the National Natural Science Foundation of China (NSFC), and 5 projects from the Ministry of Science and Technology, Shanxi Provincial Foundation and Shanxi Medical University. His research mainly focuses on the immunogenicity and safety of hepatitis B vaccine among people at high risk for HBV infection. His research also focuses on investigating the environmental and genetic factors on risk of mother-baby infection of hepatitis B virus and its immunological profile as well as its mechanism. He has published more than 50 research papers in academic periodicals at home and aboard, and wrote or participated in compiling 4 treatises and textbooks.
Abstract:
Objective: To explore the long-term immune effects of different vaccination regimens for hepatitis B vaccine in methadone maintenance treatment patients.
Methods: The randomized, double-blinded, parallel-controlled trial (receiving three intramuscular injections of 20 μg or 60 μg recombinant hepatitis B vaccine at months 0, 1, and 6, respectively, Abbreviated as IM20 × 3 or IM60 × 3) in MMT patients was conducted from September 2014 to December 2015 at first trial stage. At secondary trial stage, we compared the long-term immune effects of different vaccination regimens during 3-year follow-up extended to September 2018 in 144 MMT patients who were tested at months 7.
Results: The long-term immune effects on different follow-up times of IM20 × 3 and IM60 × 3 regimen of recombinant hepatitis B vaccine were: GMC of anti-HBs, positive conversion rate, hyper-response rate: (630.400 mIU/mL vs. 742.900 mIU/mL), (80.82%, 59/73 vs. 87.32%, 62/71), (42.47%, 31/73 vs. 56.34%, 40/71) at months 7; (405.600 mIU/mL vs. 331.300 mIU/mL), (61.97%, 44/71 vs. 67.74%, 42/62), (23.94%, 17/71 vs. 30.65%, 19/62) at months 18; (218.500 mIU/mL vs. 291.500 mIU/mL), (56.41%, 22/39 vs. 62.86%, 22/35), (15.38%, 6/39 vs. 28.57%, 10/35) at months 30; (71.040 mIU/mL vs. 100.300 mIU/mL), (52.78%, 19/36 vs. 65.52%, 19/29), (16.67%, 6/36 vs. 24.14%, 7/29) at months 42. There was no significant difference at different follow-up times (P>0.05).
Conclusion: The three 60 μg hepatitis B vaccination yield a similar long-term immune effects compared to the 20 μg vaccination.
Keynote Forum
Suping Wang,
Shanxi Medical University, China
Keynote: TLR3 signaling pathway on the effect of PBMC recombinant HBsAg immune response in vitro study
Time : 13:30-14:30
Biography:
Suping Wang is a Professor of Epidemiology from Shanxi Medical University. She has been working in the field of epidemiology since 1983. She has been the Principal Investigator for 5 grants from the National Natural Science Foundation of China (NSFC), and about 20 projects from the Ministry of Science and Technology, the Ministry of Education and Shanxi Provincial Foundation. Her research mainly focuses on investigating the environmental and genetic factors on risk of mother-baby infection of hepatitis B virus and its immunological profile as well as its mechanism. Her research also aims at studying on the relationship between the environmental and genetic factors and adverse birth outcomes. She has published more than 100 research papers in reputed journals, and wrote or participated in compiling more than 10 treatises and textbooks.
Abstract:
Objective: To investigate the effect of on the PBMC recombinant HBsAg immune response in vitro.
Methods: PBMC were divided into 3 groups: blank group, TLR3 activator group (treated with polyI:C) and TLR3 inhibitor group (treated with TLR3 inhibitor), and cultured for 48h. TLR3 signaling pathway molecules in the collected cells were detected by Flow Cytometry, and TLR3/TRIF mRNA and HBV DNA in PBMC by quantitative real-time PCR. Then all the 3 groups were treated with recombinant HBsAg and cultured for 72h, and immune cells were detected by Flow Cytometry.
Results: The percentage of TLR3 (19.21%), pNF-κBp65 (13.73%), pIRF3 positive cells in PBMC (12.64%) among polyI:C group were significantly higher than those in blank group (11.54%, 8.72%, 9.71%, respectively) (P<0.05). The percentage of TLR3 (8.56%) and TRIF (89.61%), NF-κBp65 (89.22%) and IRF3 (91.62%) positive cells in TLR3 inhibitor group were slightly lower than blank group (11.54%, 89.64%, 90.97%, 92.99%, respectively). The expression level of TLR3 (8.98×103) and NF-κBp65 (2.62×104) in polyI:C group were significantly higher than that in blank group (8.09×103 and 2.23×104) (P<0.05). The expression of TLR3 in inhibitor group (7.54×103) was lower than blank group (P=0.045). After PBMC treated with rHBsAg, the proportion of B cells in lymphocytes (5.31%) and plasma cells in B cells (67.71%) among polyI:C group were higher than blank group (4.23% and 58.82%) (P<0.05). The proportions of mDC (4.12%) and pDC (2.96%) in PBMC were also increased compared with blank group (2.51% and 1.73%).
Conclusion: The increased expression of TLR3 protein and activation of NF-κB and IRF3 may promote the maturation of B cells and DC cells, which play an antigen-presenting role and promote formation of plasma cells, and then improve the potential of expression of anti-HBs to enhance the immune response to rHBsAg.
- Vaccines | Vaccines against Infectious Diseases | Current Research & Future Challenges | Pediatric Vaccination | Cancer, Malaria & TB Vaccines | Travel & Edible Vaccines | Vaccines & Autism | Vaccines for Pregnant Women & Neonates | Vaccine Production & Development
Chair
Helder Fernando BrÃgido MARTINS
Retired Senior Manager at WHO, Mozambique
Session Introduction
Liwei He
Sanofi Pasteur, Canada
Title: Flow cytometry: An efficient method for antigenicity measurement and particle characterization on an adjuvanted vaccine candidate H4-IC31 for Tuberculosis
Time : 14:30-15:00
Biography:
Abstract:
Ashish Sahai
Serum Institute of India Pvt. Ltd, India
Title: Development of new purified vero cell rabies vaccine (Rabivax-S) at the Serum Institute of India Pvt.Ltd.
Time : 15:00-15:30
Biography:
Ashish Sahai has over 29 years of rich experience in the Biotechnological industry and Research Institute. He has experience in Research and Development, Quality Control, Quality Assurance, Production of Vaccines. He has acquired experience in protein purification, molecular sieve chromatography, ion exchange chromatography, electrophoresis, affinity chromatography, polymerase chain reaction, hybridoma technology. He has specialization in downstream processing of viruses using affinity chromatography.
Abstract:
Introduction: Rabies is a 100% vaccine-preventable disease. Rabies disease still causes human deaths in the endemic areas in Asia and Africa. A cheap, rabies vaccine for humans that could be used in mass vaccination campaigns would be a valuable weapon against rabies. Serum institute of India Pvt. Ltd. has developed a new purified vero cell inactivated and lyophilized rabies vaccine (Rabivax-S) which is now a WHO prequalified rabies vaccine.
Methodology, Theoretical Orientation & Findings: Large scale production of Vero ATCC CCL81 cells were seeded in cell cube system. Then cells are infected with Pitman Moore (PM 3218) strain of rabies virus. After 48-72 hrs, infected cells are washed. The multiple harvests are collected from one cell cube system and clarified by filtration. Clarified harvest is concentrated using tangential flow filtration system. Inactivation of rabies virus is done using beta-propiolactone (BPL). Next step of purification is done by affinity column chromatography in order to remove BSA and host cell DNA and diafiltration to remove high salt concentration. Purified rabies antigen is prepared by adding stabilizer to diafiltered antigen and finally filtered by 0.22 micron filtration and stored in ethyl vinyl acetate bags. A number of purified rabies antigen bags are blended to achieve set antigen content in final bulk. The liquid vaccine is filled in 1 ml USP type 1 clear and tubular vial and lyophilized. With the lyophilized vial of rabies vaccine 1.0 ml of sterile water for injection is supplied as a diluents.
Conclusion & Significance: Study gives well developed new purified vero cell rabies vaccine (Rabivax-S), following all the GMP requirements. Animal study has demonstrated no toxicity issue. We evaluated its safety, toxicity and immunogenicity in post-exposure prophylaxis in clinical trials by IM and ID routes. This vaccine is good option among the available modern WHO prequalified rabies vaccine. Filling, lyophilization and packaging of final product.
Yongliang Feng
Shanxi Medical University, China
Title: Long-term immune effects of different vaccination regimens for hepatitis B vaccine among patients receiving methadone maintenance treatment: Secondary analysis of a randomized clinical trial
Time : 15:45-16:15
Biography:
Yongliang Feng is an Associate Professor of Epidemiology from Shanxi Medical University, Taiyuan, China. He has been working in the field of epidemiology since 2005. He has been the Principal Investigator for 1 grants from the National Natural Science Foundation of China (NSFC), and 5 projects from the Ministry of Science and Technology, Shanxi Provincial Foundation and Shanxi Medical University. His research mainly focuses on the immunogenicity and safety of hepatitis B vaccine among people at high risk for HBV infection. His research also focuses on investigating the environmental and genetic factors on risk of mother-baby infection of hepatitis B virus and its immunological profile as well as its mechanism. He has published more than 50 research papers in academic periodicals at home and aboard, and wrote or participated in compiling 4 treatises and textbooks.
Abstract:
Objective: To explore the long-term immune effects of different vaccination regimens for hepatitis B vaccine in methadone maintenance treatment patients.
Methods: The randomized, double-blinded, parallel-controlled trial (receiving three intramuscular injections of 20 μg or 60 μg recombinant hepatitis B vaccine at months 0, 1, and 6, respectively, Abbreviated as IM20 × 3 or IM60 × 3) in MMT patients was conducted from September 2014 to December 2015 at first trial stage. At secondary trial stage, we compared the long-term immune effects of different vaccination regimens during 3-year follow-up extended to September 2018 in 144 MMT patients who were tested at months 7.
Results: The long-term immune effects on different follow-up times of IM20 × 3 and IM60 × 3 regimen of recombinant hepatitis B vaccine were: GMC of anti-HBs, positive conversion rate, hyper-response rate: (630.400 mIU/mL vs. 742.900 mIU/mL), (80.82%, 59/73 vs. 87.32%, 62/71), (42.47%, 31/73 vs. 56.34%, 40/71) at months 7; (405.600 mIU/mL vs. 331.300 mIU/mL), (61.97%, 44/71 vs. 67.74%, 42/62), (23.94%, 17/71 vs. 30.65%, 19/62) at months 18; (218.500 mIU/mL vs. 291.500 mIU/mL), (56.41%, 22/39 vs. 62.86%, 22/35), (15.38%, 6/39 vs. 28.57%, 10/35) at months 30; (71.040 mIU/mL vs. 100.300 mIU/mL), (52.78%, 19/36 vs. 65.52%, 19/29), (16.67%, 6/36 vs. 24.14%, 7/29) at months 42. There was no significant difference at different follow-up times (P>0.05).
Conclusion: The three 60 μg hepatitis B vaccination yield a similar long-term immune effects compared to the 20 μg vaccination.
Suping Wang
Shanxi Medical University, China
Title: TLR3 signaling pathway on the effect of PBMC recombinant HBsAg immune response in vitro study
Time : 16:15-16:45
Biography:
Suping Wang is a Professor of Epidemiology from Shanxi Medical University. She has been working in the field of epidemiology since 1983. She has been the Principal Investigator for 5 grants from the National Natural Science Foundation of China (NSFC), and about 20 projects from the Ministry of Science and Technology, the Ministry of Education and Shanxi Provincial Foundation. Her research mainly focuses on investigating the environmental and genetic factors on risk of mother-baby infection of hepatitis B virus and its immunological profile as well as its mechanism. Her research also aims at studying on the relationship between the environmental and genetic factors and adverse birth outcomes. She has published more than 100 research papers in reputed journals, and wrote or participated in compiling more than 10 treatises and textbooks.
Abstract:
Objective: To investigate the effect of on the PBMC recombinant HBsAg immune response in vitro.
Methods: PBMC were divided into 3 groups: blank group, TLR3 activator group (treated with polyI:C) and TLR3 inhibitor group (treated with TLR3 inhibitor), and cultured for 48h. TLR3 signaling pathway molecules in the collected cells were detected by Flow Cytometry, and TLR3/TRIF mRNA and HBV DNA in PBMC by quantitative real-time PCR. Then all the 3 groups were treated with recombinant HBsAg and cultured for 72h, and immune cells were detected by Flow Cytometry.
Results: The percentage of TLR3 (19.21%), pNF-κBp65 (13.73%), pIRF3 positive cells in PBMC (12.64%) among polyI:C group were significantly higher than those in blank group (11.54%, 8.72%, 9.71%, respectively) (P<0.05). The percentage of TLR3 (8.56%) and TRIF (89.61%), NF-κBp65 (89.22%) and IRF3 (91.62%) positive cells in TLR3 inhibitor group were slightly lower than blank group (11.54%, 89.64%, 90.97%, 92.99%, respectively). The expression level of TLR3 (8.98×103) and NF-κBp65 (2.62×104) in polyI:C group were significantly higher than that in blank group (8.09×103 and 2.23×104) (P<0.05). The expression of TLR3 in inhibitor group (7.54×103) was lower than blank group (P=0.045). After PBMC treated with rHBsAg, the proportion of B cells in lymphocytes (5.31%) and plasma cells in B cells (67.71%) among polyI:C group were higher than blank group (4.23% and 58.82%) (P<0.05). The proportions of mDC (4.12%) and pDC (2.96%) in PBMC were also increased compared with blank group (2.51% and 1.73%).
Conclusion: The increased expression of TLR3 protein and activation of NF-κB and IRF3 may promote the maturation of B cells and DC cells, which play an antigen-presenting role and promote formation of plasma cells, and then improve the potential of expression of anti-HBs to enhance the immune response to rHBsAg.