Search

Your search keyword '"Shaligram, Umesh"' showing total 148 results
Start Over Author "Shaligram, Umesh"
148 results on '"Shaligram, Umesh"'

1. Safety and efficacy of malaria vaccine candidate R21/Matrix-M in African children: a multicentre, double-blind, randomised, phase 3 trial

Author

Mahamar, Almahamoudou, Sanogo, Koualy, Sidibe, Youssoufa, Diarra, Kalifa, Samassekou, Mamoudou, Attaher, Oumar, Tapily, Amadou, Diallo, Makonon, Dicko, Oumar Mohamed, Kaya, Mahamadou, Maguiraga, Seydina Oumar, Sankare, Yaya, Yalcouye, Hama, Diarra, Soumaila, Niambele, Sidi Mohamed, Thera, Ismaila, Sagara, Issaka, Sylla, Mala, Dolo, Amagana, Misidai, Nsajigwa, Simando, Sylvester, Msami, Hania, Juma, Omary, Gutapaka, Nicolaus, Paul, Rose, Mswata, Sarah, Sasamalo, Ibrahim, Johaness, Kasmir, Sultan, Mwantumu, Alexander, Annastazia, Kimaro, Isaac, Lwanga, Kauye, Mtungwe, Mwajuma, Khamis, Kassim, Rugarabam, Lighton, Kalinga, Wilmina, Mohammed, Mohammed, Kamange, Janeth, Msangi, Jubilate, Mwaijande, Batuli, Mtaka, Ivanny, Mhapa, Matilda, Mlaganile, Tarsis, Mbaga, Thabit, Yerbanga, Rakiswende Serge, Samtouma, Wendkouni, Sienou, Abdoul Aziz, Kabre, Zachari, Ouedraogo, Wendinpui Jedida Muriel, Yarbanga, G Armel Bienvenu, Zongo, Issaka, Savadogo, Hamade, Sanon, Joseph, Compaore, Judicael, Kere, Idrissa, Yoni, Ferdinand Lionel, Sanre, Tewende Martine, Ouattara, Seydou Bienvenu, Provstgaard-Morys, Samuel, Woods, Danielle, Snow, Robert W., Amek, Nyaguara, Ngetsa, Caroline J., Ochola-Oyier, Lynette Isabella, Musyoki, Jennifer, Munene, Marianne, Mumba, Noni, Adetifa, Uche Jane, Muiruri, Charles Mwangi, Mwawaka, Jimmy Shangala, Mwaganyuma, Mwatasa Hussein, Ndichu, Martha Njeri, Weya, Joseph Ochieng, Njogu, Kelvin, Grant, Jane, Webster, Jayne, Lakhkar, Anand, Ido, N. Félix André, Traore, Ousmane, Tahita, Marc Christian, Bonko, Massa dit Achille, Rouamba, Toussaint, Ouedraogo, D. Florence, Soma, Rachidatou, Millogo, Aida, Ouedraogo, Edouard, Sorgho, Faizatou, Konate, Fabé, Valea, Innocent, Datoo, Mehreen S, Dicko, Alassane, Tinto, Halidou, Ouédraogo, Jean-Bosco, Hamaluba, Mainga, Olotu, Ally, Beaumont, Emma, Ramos Lopez, Fernando, Natama, Hamtandi Magloire, Weston, Sophie, Chemba, Mwajuma, Compaore, Yves Daniel, Issiaka, Djibrilla, Salou, Diallo, Some, Athanase M, Omenda, Sharon, Lawrie, Alison, Bejon, Philip, Rao, Harish, Chandramohan, Daniel, Roberts, Rachel, Bharati, Sandesh, Stockdale, Lisa, Gairola, Sunil, Greenwood, Brian M, Ewer, Katie J, Bradley, John, Kulkarni, Prasad S, Shaligram, Umesh, and Hill, Adrian V S

Published
2024
Full Text
View/download PDF

2. A Phase 3, randomized, non-inferiority study of a heterologous booster dose of SARS CoV-2 recombinant spike protein vaccine in adults

Author

Kulkarni, Prasad S., Gunale, Bhagwat, Kohli, Sunil, Lalwani, Sanjay, Tripathy, Srikanth, Kar, Sonali, Raut, Sidram, Kulkarni, Praveen, Apte, Aditi, Bavdekar, Ashish, Bhalla, Hira Lal, Plested, Joyce S., Cloney-Clark, Shane, Zhu, MingZhu, Kalkeri, Raj, Pryor, Melinda, Hamilton, Stephanie, Thakar, Madhuri, Sannidhi, Ranga S., Baranwal, Punjita, Bhamare, Chetanraj, Dharmadhikari, Abhijeet, Gupta, Manish, Poonawalla, Cyrus S., Shaligram, Umesh, and Kapse, Dhananjay

Published
2023
Full Text
View/download PDF

3. Immunogenicity and safety of a new quadrivalent HPV vaccine in girls and boys aged 9–14 years versus an established quadrivalent HPV vaccine in women aged 15–26 years in India: a randomised, active-controlled, multicentre, phase 2/3 trial

Author

Sharma, Hitt, Parekh, Sameer, Pujari, Pramod, Shewale, Sunil, Desai, Shivani, Bhatla, Neerja, Joshi, Smita, Pimple, Sharmila, Kawade, Anand, Balasubramani, Latha, Thomas, Anitha, Suri, Vanita, Lalwani, Sanjay, Uday, Rajini, Kamath, Veena, Mandal, Ranajit, Rajeswar, A, Peedicayil, Abraham, Poli, Usha Rani, Banerjee, Dipanwita, Sankaranarayanan, Rengaswamy, Basu, Partha, Muwonge, Richard, Gairola, Sunil, Dogar, Vikas, Rao, Harish, and Shaligram, Umesh

Published
2023
Full Text
View/download PDF

4. Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled study

Author

Kanitkar, Shubhangi A., Kakrani, Arjun L., Tripathy, Srikanth P., Tilak, Abhijit V., Dhamne, Akshay A., Mirza, Shahzad Beg, Athavale, Prachi V., Bhowmik, Mandakini, Ratnakar, Parag J., Gupta, Subodh, Deotale, Vijayshri, Jain, Jyoti, Kalantri, Ashwini, Jain, Vineet, Goyal, Nidhi, Arya, Alok, Rongsen-Chandola, Temsunaro, Dasgupta, Shreyasi, Periera, Pratibha, A, Vanmathi, Kawade, Anand, Gondhali, Arunkumar, Kudyar, Palvi, Singh, Abhishek, Yadav, Ravi, Alexander, Alina, Gunasekaran, Venugopalan, Dineshbabu, Sekar, Samantaray, P.C., Ravish, H.S., Kamra, Deepshikha, Gaidhane, Shilpa, Zahiruddin, Quazi Syed, Moni, Merlin, Kumar, Anil, Dravid, Ameet, Mohan, Anant, Suri, Tejas, Patel, Tejas K., Kishore, Surekha, Choche, Rahul, Ghatage, Deepak, Salvi, Sugam, Kulkarni, Prasad S., Kadam, Abhijit, Godbole, Sheela, Bhatt, Varsha, Raut, Abhishek, Kohli, Sunil, Tripathi, Santanu, Kulkarni, Praveen, Ludam, Rakhi, Prabhu, Madhav, Bavdekar, Ashish, Gogtay, Nithya J., Meshram, Sushant, Kadhiravan, Tamilarasu, Kar, Sonali, Narayana, D.H. Ashwath, Samuel, Clarence, Kulkarni, Govind, Gaidhane, Abhay, Sathyapalan, Dipu, Raut, Sidram, Hadda, Vijay, Bhalla, Hira Lal, Bhamare, Chetanraj, Dharmadhikari, Abhijeet, Plested, Joyce S., Cloney-Clarke, Shane, Zhu, Mingzhu, Pryor, Melinda, Hamilton, Stephanie, Thakar, Madhuri, Shete, Ashwini, Gautam, Manish, Gupta, Nivedita, Panda, Samiran, Shaligram, Umesh, Poonawalla, Cyrus S., Bhargava, Balram, Gunale, Bhagwat, and Kapse, Dhananjay

Published
2023
Full Text
View/download PDF

5. Multi-dose Formulation Development for a Quadrivalent Human Papillomavirus Virus-Like Particle-Based Vaccine: Part II- Real-time and Accelerated Stability Studies

Author

Sharma, Nitya, Jerajani, Kaushal, Wan, Ying, Kumru, Ozan S., Pullagurla, Swathi R., Ogun, Oluwadara, Mapari, Shweta, Brendle, Sarah, Christensen, Neil D., Batwal, Saurabh, Mahedvi, Mustafa, Rao, Harish, Dogar, Vikas, Chandrasekharan, Rahul, Shaligram, Umesh, Volkin, David B., and Joshi, Sangeeta B.

Published
2023
Full Text
View/download PDF

6. Multi-Dose Formulation Development for a Quadrivalent Human Papillomavirus Virus-Like Particle-Based Vaccine: Part I - Screening of Preservative Combinations

Author

Jerajani, Kaushal, Wan, Ying, Kumru, Ozan S., Pullagurla, Swathi R., Kumar, Prashant, Sharma, Nitya, Ogun, Oluwadara, Mapari, Shweta, Brendle, Sarah, Christensen, Neil D., Batwal, Saurabh, Mahedvi, Mustafa, Rao, Harish, Dogar, Vikas, Chandrasekharan, Rahul, Shaligram, Umesh, Joshi, Sangeeta B., and Volkin, David B.

Published
2023
Full Text
View/download PDF

7. Efficacy and immunogenicity of R21/Matrix-M vaccine against clinical malaria after 2 years' follow-up in children in Burkina Faso: a phase 1/2b randomised controlled trial

Author

Datoo, Mehreen S, Natama, Hamtandi Magloire, Somé, Athanase, Bellamy, Duncan, Traoré, Ousmane, Rouamba, Toussaint, Tahita, Marc Christian, Ido, N Félix André, Yameogo, Prisca, Valia, Daniel, Millogo, Aida, Ouedraogo, Florence, Soma, Rachidatou, Sawadogo, Seydou, Sorgho, Faizatou, Derra, Karim, Rouamba, Eli, Ramos-Lopez, Fernando, Cairns, Matthew, Provstgaard-Morys, Samuel, Aboagye, Jeremy, Lawrie, Alison, Roberts, Rachel, Valéa, Innocent, Sorgho, Hermann, Williams, Nicola, Glenn, Gregory, Fries, Louis, Reimer, Jenny, Ewer, Katie J, Shaligram, Umesh, Hill, Adrian V S, and Tinto, Halidou

Published
2022
Full Text
View/download PDF

8. Analytical and Preformulation Characterization Studies of Human Papillomavirus Virus-Like Particles to Enable Quadrivalent Multi-Dose Vaccine Formulation Development

Author

Jerajani, Kaushal, Wan, Ying, Hickey, John M., Kumru, Ozan S., Sharma, Nitya, Pullagurla, Swathi R., Ogun, Oluwadara, Mapari, Shweta, Whitaker, Neal, Brendle, Sarah, Christensen, Neil D., Batwal, Saurabh, Mahedvi, Mustafa, Rao, Harish, Dogar, Vikas, Chandrasekharan, Rahul, Shaligram, Umesh, Joshi, Sangeeta B., and Volkin, David B.

Published
2022
Full Text
View/download PDF

9. Safety and immunogenicity of VPM1002 versus BCG in South African newborn babies: a randomised, phase 2 non-inferiority double-blind controlled trial

Author

Cotton, Mark F, Madhi, Shabir A, Luabeya, Angelique K, Tameris, Michele, Hesseling, Anneke C, Shenje, Justin, Schoeman, Elisma, Hatherill, Mark, Desai, Sajjad, Kapse, Dhananjay, Brückner, Sina, Koen, Anthonet, Jose, Lisa, Moultrie, Andrew, Bhikha, Sutika, Walzl, Gerhard, Gutschmidt, Andrea, Kotze, Leigh A, Allies, Devon L, Loxton, Andre G, Shaligram, Umesh, Abraham, Maria, Johnstone, Hilary, Grode, Leander, Kaufmann, S H E, and Kulkarni, Prasad S

Published
2022
Full Text
View/download PDF

10. A Combined LC-MS and Immunoassay Approach to Characterize Preservative-Induced Destabilization of Human Papillomavirus Virus-like Particles Adsorbed to an Aluminum-Salt Adjuvant

Author

Caringal, Ria T., primary, Hickey, John M., additional, Sharma, Nitya, additional, Jerajani, Kaushal, additional, Bewaji, Oluwadara, additional, Brendle, Sarah, additional, Christensen, Neil, additional, Batwal, Saurabh, additional, Mahedvi, Mustafa, additional, Rao, Harish, additional, Dogar, Vikas, additional, Chandrasekharan, Rahul, additional, Shaligram, Umesh, additional, Joshi, Sangeeta B., additional, and Volkin, David B., additional

Published
2024
Full Text
View/download PDF

11. A phase 2/3, participant-blind, observer-blind, randomised, controlled study to assess the safety and immunogenicity of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine) in adults in India

Author

Kulkarni, Prasad S, Padmapriyadarsini, Chandrasekaran, Vekemans, Johan, Bavdekar, Ashish, Gupta, Madhu, Kulkarni, Praveen, Garg, B S, Gogtay, Nithya J, Tambe, Muralidhar, Lalwani, Sanjay, Singh, Kiranjit, Munshi, Renuka, Meshram, Sushant, Selvavinayagam, T S, Pandey, Krishna, Bhimarasetty, Devi Madhavi, Ramakrishnan, S R, Bhamare, Chetanraj, Dharmadhikari, Abhijeet, Vadakkedath, Rajeev, Bonhomme, Cyrille J, Thakar, Madhuri, Kurle, Swarali N, Kelly, Elizabeth J, Gautam, Manish, Gupta, Nivedita, Panda, Samiran, Bhargava, Balram, Shaligram, Umesh, Kapse, Dhananjay, and Gunale, Bhagwat

Published
2021
Full Text
View/download PDF

12. Efficacy of a low-dose candidate malaria vaccine, R21 in adjuvant Matrix-M, with seasonal administration to children in Burkina Faso: a randomised controlled trial

Author

Datoo, Mehreen S, Natama, Magloire H, Somé, Athanase, Traoré, Ousmane, Rouamba, Toussaint, Bellamy, Duncan, Yameogo, Prisca, Valia, Daniel, Tegneri, Moubarak, Ouedraogo, Florence, Soma, Rachidatou, Sawadogo, Seydou, Sorgho, Faizatou, Derra, Karim, Rouamba, Eli, Orindi, Benedict, Ramos Lopez, Fernando, Flaxman, Amy, Cappuccini, Federica, Kailath, Reshma, Elias, Sean, Mukhopadhyay, Ekta, Noe, Andres, Cairns, Matthew, Lawrie, Alison, Roberts, Rachel, Valéa, Innocent, Sorgho, Hermann, Williams, Nicola, Glenn, Gregory, Fries, Louis, Reimer, Jenny, Ewer, Katie J, Shaligram, Umesh, Hill, Adrian V S, and Tinto, Halidou

Published
2021
Full Text
View/download PDF

13. Validation and Suitability Assessment of Multiplex Mesoscale Discovery Immunogenicity Assay for Establishing Serological Signatures Using Vaccinated, Non-vaccinated and Breakthrough SARS-COV-2 Infected Cases

Author

Shengule, Sushant, primary, Alai, Shweta, additional, Bhandare, Sachin, additional, Patil, Sumant, additional, Gautam, Manish, additional, Mangaonkar, Bhushan, additional, Gupta, Sumit, additional, Shaligram, Umesh, additional, and Gairola, Sunil, additional

Published
2024
Full Text
View/download PDF

15. Validation and Suitability Assessment of Multiplex Mesoscale Discovery Immunogenicity Assay for Establishing Serological Signatures Using Vaccinated, Non-Vaccinated and Breakthrough SARS-CoV-2 Infected Cases.

Author

Shengule, Sushant, Alai, Shweta, Bhandare, Sachin, Patil, Sumant, Gautam, Manish, Mangaonkar, Bhushan, Gupta, Sumit, Shaligram, Umesh, and Gairola, Sunil

Subjects
SARS-CoV-2, IMMUNE response
Abstract

Antibody responses to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are multi-targeted and variable over time. Multiplex quantitative serological assays are needed to provide accurate and robust seropositivity data for the establishment of serological signatures during vaccination and or infection. We describe here the validation and evaluation of an electro-chemiluminescence (ECL)-based Mesoscale Discovery assay (MSD) for estimation of total and functional IgG relative to SARS-CoV-2 spike, nucleocapsid and receptor binding (RBD) proteins in human serum samples to establish serological signatures of SARS-CoV-2 natural infection and breakthrough cases. The 9-PLEX assay was validated as per ICH, EMA, and US FDA guidelines using a panel of sera samples, including the NIBSC/WHO reference panel (20/268). The assay demonstrated high specificity and selectivity in inhibition assays, wherein the homologous inhibition was more than 85% and heterologous inhibition was below 10%. The assay also met predetermined acceptance criteria for precision (CV < 20%), accuracy (70–130%) and dilutional linearity. The method's applicability to serological signatures was demonstrated using sera samples (n = 45) representing vaccinated, infected and breakthrough cases. The method was able to establish distinct serological signatures and thus provide a potential tool for seroprevalence of SARS-CoV-2 during vaccination or infection. [ABSTRACT FROM AUTHOR]

Published
2024
Full Text
View/download PDF

16. Large-Scale Purification and Characterization of Recombinant Receptor-Binding Domain (RBD) of SARS-CoV-2 Spike Protein Expressed in Yeast

Author

Nagar, Gaurav, primary, Jain, Siddharth, additional, Rajurkar, Meghraj, additional, Lothe, Rakesh, additional, Rao, Harish, additional, Majumdar, Sourav, additional, Gautam, Manish, additional, Rodriguez-Aponte, Sergio A., additional, Crowell, Laura E., additional, Love, J. Christopher, additional, Dandekar, Prajakta, additional, Puranik, Amita, additional, Gairola, Sunil, additional, Shaligram, Umesh, additional, and Jain, Ratnesh, additional

Published
2023
Full Text
View/download PDF

17. Safety and immunogenicity of SIIPL Tdap, a new tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, in healthy subjects 4–65 years of age: A Phase II/III randomized, observer-blinded, active controlled, multicenter clinical study in Germany

Author

Aydin, Inci, primary, May, Marcus, additional, Pisano, Fabio, additional, Mpofu-Maetzig, Nontsikelelo, additional, Grode, Leander, additional, Parekh, Sameer, additional, Pujari, Pramod, additional, Shewale, Sunil, additional, Desai, Shivani, additional, Sharma, Hitt, additional, Rao, Harish, additional, Gautam, Manish, additional, Gairola, Sunil, additional, and Shaligram, Umesh, additional

Published
2023
Full Text
View/download PDF

18. The 100 Days Mission: how a new medical-countermeasures network can deliver equity and innovation

Author

Dzau, Victor, primary, Swaminathan, Soumya, additional, Baker, Charlotte, additional, Bright, Rick A, additional, Castillo, Jose, additional, Chuan, Tan Chorh, additional, Draghia-Akli, Ruxandra, additional, Eardley-Patel, Ranna, additional, Gao, George F, additional, Ishii, Ken, additional, Tebeje, Yenew Kebede, additional, Lambe, Teresa, additional, Machingaidze, Shingai, additional, Røttingen, John-Arne, additional, Shaligram, Umesh, additional, Simão, Mariângela, additional, Swarup, Renu, additional, Toussaint, Jean-Francois, additional, and Wairagkar, Niteen S, additional

Published
2023
Full Text
View/download PDF

22. Multiplexed bead-based assay for the simultaneous quantification of human serum IgG antibodies to tetanus, diphtheria, pertussis toxin, filamentous hemagglutinin, and pertactin

Author

Rathod, Vishal, primary, Kadam, Laxmikant, additional, Gautam, Manish, additional, Gumma, Prabhu Dasu, additional, Marke, Kevin, additional, Asokanathan, Cathy, additional, Douglas-Bardsley, Alex, additional, Hassell, Laura, additional, Bhandare, Sachin, additional, Gupta, Sumit, additional, Parekh, Sameer, additional, Pujari, Pramod, additional, Rao, Harish, additional, Sharma, Hitt, additional, Shaligram, Umesh, additional, and Gairola, Sunil, additional

Published
2023
Full Text
View/download PDF

23. A phase-I, open label clinical trial to assess the safety & tolerability of qHPV vaccine manufactured by Serum Institute of India Pvt. Ltd. in adults

Author

Sharma, Hitt, primary, Anil, K., additional, Parekh, Sameer, additional, Pujari, Pramod, additional, Shewale, Sunil, additional, Desai, Shivani, additional, Madhusudhan, R.L., additional, Patel, Jaya, additional, Eswaraiah, Anand, additional, Rao, Harish, additional, Gairola, Sunil, additional, and Shaligram, Umesh, additional

Published
2023
Full Text
View/download PDF

24. Large-Scale Purification and Characterization of Recombinant Receptor-Binding Domain (RBD) of SARS-CoV-2 Spike Protein Expressed in Yeast

Author

Massachusetts Institute of Technology. Department of Biological Engineering, Koch Institute for Integrative Cancer Research at MIT, Massachusetts Institute of Technology. Department of Chemical Engineering, Nagar, Gaurav, Jain, Siddharth, Rajurkar, Meghraj, Lothe, Rakesh, Rao, Harish, Majumdar, Sourav, Gautam, Manish, Rodriguez-Aponte, Sergio A., Crowell, Laura E., Love, J. Christopher, Dandekar, Prajakta, Puranik, Amita, Gairola, Sunil, Shaligram, Umesh, Jain, Ratnesh, Massachusetts Institute of Technology. Department of Biological Engineering, Koch Institute for Integrative Cancer Research at MIT, Massachusetts Institute of Technology. Department of Chemical Engineering, Nagar, Gaurav, Jain, Siddharth, Rajurkar, Meghraj, Lothe, Rakesh, Rao, Harish, Majumdar, Sourav, Gautam, Manish, Rodriguez-Aponte, Sergio A., Crowell, Laura E., Love, J. Christopher, Dandekar, Prajakta, Puranik, Amita, Gairola, Sunil, Shaligram, Umesh, and Jain, Ratnesh

Abstract

SARS-CoV-2 spike protein is an essential component of numerous protein-based vaccines for COVID-19. The receptor-binding domain of this spike protein is a promising antigen with ease of expression in microbial hosts and scalability at comparatively low production costs. This study describes the production, purification, and characterization of RBD of SARS-CoV-2 protein, which is currently in clinical trials, from a commercialization perspective. The protein was expressed in Pichia pastoris in a large-scale bioreactor of 1200 L capacity. Protein capture and purification are conducted through mixed-mode chromatography followed by hydrophobic interaction chromatography. This two-step purification process produced RBD with an overall productivity of ~21 mg/L at >99% purity. The protein’s primary, secondary, and tertiary structures were also verified using LCMS-based peptide mapping, circular dichroism, and fluorescence spectroscopy, respectively. The glycoprotein was further characterized for quality attributes such as glycosylation, molecular weight, purity, di-sulfide bonding, etc. Through structural analysis, it was confirmed that the product maintained a consistent quality across different batches during the large-scale production process. The binding capacity of RBD of spike protein was also assessed using human angiotensin-converting enzyme 2 receptor. A low binding constant range of KD values, ranging between 3.63 × 10−8 to 6.67 × 10−8, demonstrated a high affinity for the ACE2 receptor, revealing this protein as a promising candidate to prevent the entry of COVID-19 virus.

Published
2023

25. Safety and efficacy of malaria vaccine candidate R21/Matrix-M in African children: a multicentre, double-blind, randomised, phase 3 trial

Author

Datoo, Mehreen S, Dicko, Alassane, Tinto, Halidou, Ouédraogo, Jean-Bosco, Hamaluba, Mainga, Olotu, Ally, Beaumont, Emma, Ramos Lopez, Fernando, Natama, Hamtandi Magloire, Weston, Sophie, Chemba, Mwajuma, Compaore, Yves Daniel, Issiaka, Djibrilla, Salou, Diallo, Some, Athanase M, Omenda, Sharon, Lawrie, Alison, Bejon, Philip, Rao, Harish, Chandramohan, Daniel, Roberts, Rachel, Bharati, Sandesh, Stockdale, Lisa, Gairola, Sunil, Greenwood, Brian M, Ewer, Katie J, Bradley, John, Kulkarni, Prasad S, Shaligram, Umesh, Hill, Adrian V S, Mahamar, Almahamoudou, Sanogo, Koualy, Sidibe, Youssoufa, Diarra, Kalifa, Samassekou, Mamoudou, Attaher, Oumar, Tapily, Amadou, Diallo, Makonon, Dicko, Oumar Mohamed, Kaya, Mahamadou, Maguiraga, Seydina Oumar, Sankare, Yaya, Yalcouye, Hama, Diarra, Soumaila, Niambele, Sidi Mohamed, Thera, Ismaila, Sagara, Issaka, Sylla, Mala, Dolo, Amagana, Misidai, Nsajigwa, Simando, Sylvester, Msami, Hania, Juma, Omary, Gutapaka, Nicolaus, Paul, Rose, Mswata, Sarah, Sasamalo, Ibrahim, Johaness, Kasmir, Sultan, Mwantumu, Alexander, Annastazia, Kimaro, Isaac, Lwanga, Kauye, Mtungwe, Mwajuma, Khamis, Kassim, Rugarabam, Lighton, Kalinga, Wilmina, Mohammed, Mohammed, Kamange, Janeth, Msangi, Jubilate, Mwaijande, Batuli, Mtaka, Ivanny, Mhapa, Matilda, Mlaganile, Tarsis, Mbaga, Thabit, Yerbanga, Rakiswende Serge, Samtouma, Wendkouni, Sienou, Abdoul Aziz, Kabre, Zachari, Ouedraogo, Wendinpui Jedida Muriel, Yarbanga, G Armel Bienvenu, Zongo, Issaka, Savadogo, Hamade, Sanon, Joseph, Compaore, Judicael, Kere, Idrissa, Yoni, Ferdinand Lionel, Sanre, Tewende Martine, Ouattara, Seydou Bienvenu, Provstgaard-Morys, Samuel, Woods, Danielle, Snow, Robert W., Amek, Nyaguara, Ngetsa, Caroline J., Ochola-Oyier, Lynette Isabella, Musyoki, Jennifer, Munene, Marianne, Mumba, Noni, Adetifa, Uche Jane, Muiruri, Charles Mwangi, Mwawaka, Jimmy Shangala, Mwaganyuma, Mwatasa Hussein, Ndichu, Martha Njeri, Weya, Joseph Ochieng, Njogu, Kelvin, Grant, Jane, Webster, Jayne, Lakhkar, Anand, Ido, N. Félix André, Traore, Ousmane, Tahita, Marc Christian, Bonko, Massa dit Achille, Rouamba, Toussaint, Ouedraogo, D. Florence, Soma, Rachidatou, Millogo, Aida, Ouedraogo, Edouard, Sorgho, Faizatou, Konate, Fabé, and Valea, Innocent

Abstract

Recently, we found that a new malaria vaccine, R21/Matrix-M, had over 75% efficacy against clinical malaria with seasonal administration in a phase 2b trial in Burkina Faso. Here, we report on safety and efficacy of the vaccine in a phase 3 trial enrolling over 4800 children across four countries followed for up to 18 months at seasonal sites and 12 months at standard sites.

Published
2024
Full Text
View/download PDF

26. Safety and immunogenicity of an indigenously developed tetanus toxoid, diphtheria toxoid, and acellular pertussis vaccine (Tdap) in adults, adolescents, and children in India

Author

Sharma, Hitt J, primary, Parekh, Sameer, additional, Pujari, Pramod, additional, Shewale, Sunil, additional, Desai, Shivani, additional, Kawade, Anand, additional, Ravi, Mandyam, additional, Oswal, Jitendra, additional, James, Saji, additional, Mahantashetti, N., additional, Munshi, Renuka, additional, Ghosh, Apurba, additional, Rao, Venkateshwar, additional, Balsubramaniam, Sundaram, additional, Varughese, P., additional, Somshekhar, A., additional, Ginsburg, Amy Sarah, additional, Rao, Harish, additional, Gautam, Manish, additional, Gairola, Sunil, additional, and Shaligram, Umesh, additional

Published
2023
Full Text
View/download PDF

27. Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled study

Author

Kulkarni, Prasad S., primary, Kadam, Abhijit, additional, Godbole, Sheela, additional, Bhatt, Varsha, additional, Raut, Abhishek, additional, Kohli, Sunil, additional, Tripathi, Santanu, additional, Kulkarni, Praveen, additional, Ludam, Rakhi, additional, Prabhu, Madhav, additional, Bavdekar, Ashish, additional, Gogtay, Nithya J., additional, Meshram, Sushant, additional, Kadhiravan, Tamilarasu, additional, Kar, Sonali, additional, Narayana, D.H. Ashwath, additional, Samuel, Clarence, additional, Kulkarni, Govind, additional, Gaidhane, Abhay, additional, Sathyapalan, Dipu, additional, Raut, Sidram, additional, Hadda, Vijay, additional, Bhalla, Hira Lal, additional, Bhamare, Chetanraj, additional, Dharmadhikari, Abhijeet, additional, Plested, Joyce S., additional, Cloney-Clarke, Shane, additional, Zhu, Mingzhu, additional, Pryor, Melinda, additional, Hamilton, Stephanie, additional, Thakar, Madhuri, additional, Shete, Ashwini, additional, Gautam, Manish, additional, Gupta, Nivedita, additional, Panda, Samiran, additional, Shaligram, Umesh, additional, Poonawalla, Cyrus S., additional, Bhargava, Balram, additional, Gunale, Bhagwat, additional, Kapse, Dhananjay, additional, Kanitkar, Shubhangi A., additional, Kakrani, Arjun L., additional, Tripathy, Srikanth P., additional, Tilak, Abhijit V., additional, Dhamne, Akshay A., additional, Mirza, Shahzad Beg, additional, Athavale, Prachi V., additional, Bhowmik, Mandakini, additional, Ratnakar, Parag J., additional, Gupta, Subodh, additional, Deotale, Vijayshri, additional, Jain, Jyoti, additional, Kalantri, Ashwini, additional, Jain, Vineet, additional, Goyal, Nidhi, additional, Arya, Alok, additional, Rongsen-Chandola, Temsunaro, additional, Dasgupta, Shreyasi, additional, Periera, Pratibha, additional, A, Vanmathi, additional, Kawade, Anand, additional, Gondhali, Arunkumar, additional, Kudyar, Palvi, additional, Singh, Abhishek, additional, Yadav, Ravi, additional, Alexander, Alina, additional, Gunasekaran, Venugopalan, additional, Dineshbabu, Sekar, additional, Samantaray, P.C., additional, Ravish, H.S., additional, Kamra, Deepshikha, additional, Gaidhane, Shilpa, additional, Zahiruddin, Quazi Syed, additional, Moni, Merlin, additional, Kumar, Anil, additional, Dravid, Ameet, additional, Mohan, Anant, additional, Suri, Tejas, additional, Patel, Tejas K., additional, Kishore, Surekha, additional, Choche, Rahul, additional, Ghatage, Deepak, additional, and Salvi, Sugam, additional

Published
2023
Full Text
View/download PDF

28. A randomized, controlled study to evaluate the safety and immunogenicity of a heterologous booster dose of an adjuvanted SARS CoV-2 recombinant spike protein vaccine in adults

Author

Kulkarni, Prasad, primary, Gunale, Bhagwat, additional, Kohli, Sunil, additional, Lalwani, Sanjay, additional, Tripathy, Srikanth, additional, Kar, Sonali, additional, Raut, Sidram, additional, Kulkarni, Praveen, additional, Apte, Aditi, additional, Bavdekar, Ashish, additional, Bhalla, Hira Lal, additional, Plested, Joyce, additional, Cloney-Clark, Shane, additional, Zhu, MingZhu, additional, Kalkeri, Raj, additional, Pryor, Melinda, additional, Hamilton, Stephanie, additional, Thakar, Madhuri, additional, Sannidhi, Ranga, additional, Baranwal, Punjita, additional, Bhamare, Chetanraj, additional, Dharmadhikari, Abhijeet, additional, Gupta, Manish, additional, Poonawalla, Cyrus, additional, Shaligram, Umesh, additional, and Kapse, Dhananjay, additional

Published
2023
Full Text
View/download PDF

29. Molecular engineering of a cryptic epitope in Spike RBD improves manufacturability and neutralizing breadth against SARS-CoV-2 variants

Author

Rodriguez-Aponte, Sergio A., primary, Dalvie, Neil C., additional, Wong, Ting Y., additional, Johnston, Ryan S., additional, Naranjo, Christopher A., additional, Bajoria, Sakshi, additional, Kumru, Ozan S., additional, Kaur, Kawaljit, additional, Russ, Brynnan P., additional, Lee, Katherine S., additional, Cyphert, Holly A., additional, Barbier, Mariette, additional, Rao, Harish D., additional, Rajurkar, Meghraj P., additional, Lothe, Rakesh R., additional, Shaligram, Umesh S., additional, Batwal, Saurabh, additional, Chandrasekaran, Rahul, additional, Nagar, Gaurav, additional, Kleanthous, Harry, additional, Biswas, Sumi, additional, Bevere, Justin R., additional, Joshi, Sangeeta B., additional, Volkin, David B., additional, Damron, F. Heath, additional, and Love, J. Christopher, additional

Published
2023
Full Text
View/download PDF

30. VPM1002 as Prophylaxis Against Severe Respiratory Tract Infections Including Coronavirus Disease 2019 in the Elderly: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study

Author

Blossey, Alexandra M, primary, Brückner, Sina, additional, May, Marcus, additional, Parzmair, Gerald P, additional, Sharma, Hitt, additional, Shaligram, Umesh, additional, Grode, Leander, additional, Kaufmann, Stefan H E, additional, Netea, Mihai G, additional, and Schindler, Christoph, additional

Published
2022
Full Text
View/download PDF

31. Development and validation of bead-based assay quantifying Tetanus, Diphtheria, Pertussis Toxin, Filamentous haemagglutinin and Pertactin specific IgG in human serum

Author

Rathod, Vishal, primary, Kadam, Laxmikant, additional, Gumma, Prabhu Dasu, additional, Gautam, Manish, additional, Sharma, Hitt, additional, Shaligram, Umesh, additional, Rao, Harish, additional, Gairola, Sunil, additional, Parekh, Sameer, additional, Marke, Kevin, additional, Asokanathan, Cathy, additional, Douglas-Bardsley, Alex, additional, and Hassell, Laura, additional

Published
2022
Full Text
View/download PDF

32. Molecular engineering of a cryptic epitope in Spike RBD improves manufacturability and neutralizing breadth against SARS-CoV-2 variants

Author

Rodriguez-Aponte, Sergio A., primary, Dalvie, Neil C., additional, Wong, Ting Y., additional, Johnston, Ryan S., additional, Naranjo, Christopher A., additional, Bajoria, Sakshi, additional, Kumru, Ozan S., additional, Kaur, Kawaljit, additional, Russ, Brynnan P., additional, Lee, Katherine S., additional, Cyphert, Holly A., additional, Barbier, Mariette, additional, Rao, Harish D., additional, Rajurkar, Meghraj P., additional, Lothe, Rakesh R., additional, Shaligram, Umesh S., additional, Batwal, Saurabh, additional, Chandrasekaran, Rahul, additional, Nagar, Gaurav, additional, Kleanthous, Harry, additional, Biswas, Sumi, additional, Bevere, Justin R., additional, Joshi, Sangeeta B., additional, Volkin, David B., additional, Damron, F. Heath, additional, and Love, J. Christopher, additional

Published
2022
Full Text
View/download PDF

33. RBD-VLP Vaccines Adjuvanted with Alum or SWE Protect K18-hACE2 Mice against SARS-CoV-2 VOC Challenge

Author

Wong, Ting Y., primary, Russ, Brynnan P., additional, Lee, Katherine S., additional, Miller, Olivia A., additional, Kang, Jason, additional, Cooper, Melissa, additional, Winters, Michael T., additional, Rodriguez-Aponte, Sergio A., additional, Dalvie, Neil C., additional, Johnston, Ryan S., additional, Rader, Nathaniel A., additional, Wong, Zeriel Y., additional, Cyphert, Holly A., additional, Martinez, Ivan, additional, Shaligram, Umesh, additional, Batwal, Saurabh, additional, Lothe, Rakesh, additional, Chandrasekaran, Rahul, additional, Nagar, Gaurav, additional, Rajurkar, Meghraj, additional, Rao, Harish, additional, Bevere, Justin R., additional, Barbier, Mariette, additional, Love, J. Christopher, additional, and Damron, F. Heath, additional

Published
2022
Full Text
View/download PDF

34. Passive immunization with equine RBD-specific Fab protects K18-hACE2-mice against Alpha or Beta variants of SARS-CoV-2

Author

Barbier, Mariette, primary, Lee, Katherine S., additional, Vikharankar, Mayur S., additional, Rajpathak, Shriram N., additional, Kadam, Nandkumar, additional, Wong, Ting Y., additional, Russ, Brynnan P., additional, Cyphert, Holly A., additional, Miller, Olivia A., additional, Rader, Nathaniel A., additional, Cooper, Melissa, additional, Kang, Jason, additional, Sen-Kilic, Emel, additional, Wong, Zeriel Y., additional, Winters, Michael T., additional, Bevere, Justin R., additional, Martinez, Ivan, additional, Devarumath, Rachayya, additional, Shaligram, Umesh S., additional, and Damron, F. Heath, additional

Published
2022
Full Text
View/download PDF

35. VPM1002 as Prophylaxis Against Severe Respiratory Tract Infections Including Coronavirus Disease 2019 in the Elderly: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study.

Author

Blossey, Alexandra M, Brückner, Sina, May, Marcus, Parzmair, Gerald P, Sharma, Hitt, Shaligram, Umesh, Grode, Leander, Kaufmann, Stefan H E, Netea, Mihai G, and Schindler, Christoph

Subjects
PREVENTION of epidemics, DRUG efficacy, INTENSIVE care units, CONFIDENCE intervals, FEVER, SELF-evaluation, RESPIRATORY infections, CORONAVIRUS diseases, DISEASE incidence, PATIENTS, ANTIBIOTIC prophylaxis, TREATMENT effectiveness, RANDOMIZED controlled trials, PLACEBOS, HOSPITAL admission & discharge, RESEARCH funding, BLIND experiment, DESCRIPTIVE statistics, HOSPITAL care, BCG vaccines, STATISTICAL sampling, BACTERIAL vaccines, PATIENT safety, PHARMACODYNAMICS, EVALUATION, OLD age
Abstract

Background Bacille Calmette-Guérin (BCG) vaccination can potentially reduce the rate of respiratory infections in vulnerable populations. This study evaluates the safety and efficacy of VPM1002 (a genetically modified BCG) as prophylaxis against severe respiratory tract infections including coronavirus disease 2019 (COVID-19) in an elderly population. Methods In this phase 3, randomized, double-blind, placebo-controlled, multicenter clinical trial, healthy elderly volunteers (N = 2064) were enrolled, randomized (1:1) to receive either VPM1002 or placebo, and followed up remotely for 240 days. The primary outcome was the mean number of days with severe respiratory infections at hospital and/or at home. Secondary endpoints included the incidence of self-reported fever, number of hospital and intensive care unit (ICU) admissions, and number of adverse events. Results A total of 31 participants in the VPM1002 group reported at least 1 day with severe respiratory disease and a mean number of days with severe respiratory disease of 9.39 ± 9.28 while in the placebo group; 38 participants reported a mean of 14.29 ± 16.25 days with severe respiratory disease. The incidence of self-reported fever was lower in the VPM1002 group (odds ratio, 0.46 [95% confidence interval,.28–.74]; P =.001), and consistent trends to fewer hospitalization and ICU admissions due to COVID-19 were observed after VPM1002 vaccination. Local reactions typical for BCG were observed in the VPM1002-vaccinated group, which were mostly of mild intensity. Conclusions Vaccination with VPM1002 is well tolerated and seems to have a prophylactic effect against severe respiratory disease in the elderly. Clinical Trials Registration NCT04435379. [ABSTRACT FROM AUTHOR]

Published
2023
Full Text
View/download PDF

36. Safety and Immunogenicity of SARS-CoV-2 Recombinant Spike Protein Vaccine in Children and Adolescents in India: A Phase 2-3 Randomized Clinical Trial

Author

Gunale, Bhagwat, Kapse, Dhananjay, Kar, Sonali, Bavdekar, Ashish, Kohli, Sunil, Lalwani, Sanjay, Meshram, Sushant, Raut, Abhishek, Kulkarni, Praveen, Samuel, Clarence, Munshi, Renuka, Gupta, Madhu, Plested, Joyce S., Cloney-Clark, Shane, Zhu, MingZhu, Pryor, Melinda, Hamilton, Stephanie, Thakar, Madhuri, Shete, Ashwini, Dharmadhikari, Abhijeet, Bhamare, Chetanraj, Shaligram, Umesh, Poonawalla, Cyrus S., Mallory, Raburn M., Glenn, Gregory M., and Kulkarni, Prasad S.

Abstract

IMPORTANCE: The recombinant COVID-19 vaccine NVX-CoV2373 has demonstrated efficacy of approximately 90% in adults; however, its safety and efficacy in children is unknown. OBJECTIVE: To assess the noninferiority of SII-NVX-CoV2373 in children and adolescents compared to adults and to evaluate its safety in comparison with placebo. DESIGN, SETTING, AND PARTICIPANTS: This phase 2-3 observer-blind randomized clinical trial was conducted in 2 cohorts, children (aged 2 to 11 years) and adolescents (aged 12 to 17 years) between August 2021 and August 2022. Participants were randomized 3:1 to SII-NVX-CoV2373 or placebo and monitored for 179 days. The participants, study team, and laboratory staff were blinded. This was a multicenter study conducted across 10 tertiary care hospitals in India. Exclusion criteria included previous COVID-19 infection or vaccination, immunocompromised condition, and immunosuppressive medications. INTERVENTIONS: Two doses of 0.5-mL SII-NVX-CoV2373 or placebo were administered intramuscularly on days 1 and 22. MAIN OUTCOMES AND MEASURES: Primary outcomes were geometric mean titer ratio of both anti-spike (anti-S) IgG and neutralizing antibodies (NAbs) between both pediatric age groups to that of adults on day 36. Noninferiority was concluded if the lower bound of 95% CI of this ratio was greater than 0.67 for each age group. Both the antibodies were assessed for the index strain and for selected variants at various time points. Solicited adverse events (AEs) were recorded for 7 days after each vaccination, unsolicited AEs were recorded for 35 days, and serious AEs and AEs of special interest were recorded for 179 days. RESULTS: A total of 460 children in each age cohort were randomized to receive vaccine or placebo. The mean (SD) age was 6.7 (2.7) years in the child cohort and 14.3 (1.6) years in the adolescent cohort; 231 participants (50.2%) in the child cohort and 218 in the adolescent cohort (47.4%) were female. Both anti-S IgG and NAb titers were markedly higher in the SII-NVX-CoV2373 group than in the placebo group on both day 36 and day 180. The geometric mean titer ratios compared to those in adults were 1.20 (95% CI, 1.08-1.34) and 1.52 (95% CI, 1.38-1.67) for anti-S IgG in adolescents and children, respectively; while for NAbs, they were 1.33 (95% CI, 1.17-1.50) and 1.93 (95% CI, 1.70-2.18) in adolescents and children, respectively, indicating noninferiority. SII-NVX-CoV2373 also showed immune responses against variants studied. Injection site reactions, fever, headache, malaise, and fatigue were common solicited AEs. There were no AEs of special interest and no causally related serious AEs. CONCLUSIONS AND RELEVANCE: SII-NVX-CoV2373 was safe and well tolerated in children and adolescents in this study. The vaccine was highly immunogenic and may be used in pediatric vaccination against COVID-19. TRIAL REGISTRATION: Clinical Trials Registry of India Identifier: CTRI/2021/02/031554

Published
2023
Full Text
View/download PDF

37. SARS-CoV-2 receptor binding domain displayed on HBsAg virus–like particles elicits protective immunity in macaques

Author

Dalvie, Neil C., primary, Tostanoski, Lisa H., additional, Rodriguez-Aponte, Sergio A., additional, Kaur, Kawaljit, additional, Bajoria, Sakshi, additional, Kumru, Ozan S., additional, Martinot, Amanda J., additional, Chandrashekar, Abishek, additional, McMahan, Katherine, additional, Mercado, Noe B., additional, Yu, Jingyou, additional, Chang, Aiquan, additional, Giffin, Victoria M., additional, Nampanya, Felix, additional, Patel, Shivani, additional, Bowman, Lesley, additional, Naranjo, Christopher A., additional, Yun, Dongsoo, additional, Flinchbaugh, Zach, additional, Pessaint, Laurent, additional, Brown, Renita, additional, Velasco, Jason, additional, Teow, Elyse, additional, Cook, Anthony, additional, Andersen, Hanne, additional, Lewis, Mark G., additional, Camp, Danielle L., additional, Silverman, Judith Maxwell, additional, Nagar, Gaurav S., additional, Rao, Harish D., additional, Lothe, Rakesh R., additional, Chandrasekharan, Rahul, additional, Rajurkar, Meghraj P., additional, Shaligram, Umesh S., additional, Kleanthous, Harry, additional, Joshi, Sangeeta B., additional, Volkin, David B., additional, Biswas, Sumi, additional, Love, J. Christopher, additional, and Barouch, Dan H., additional

Published
2022
Full Text
View/download PDF

39. Safety and Immunogenicity of SII-NVX-CoV2373 (COVID-19 Vaccine) In Adults in a Phase 2/3, Observer-Blind, Randomised, Controlled Study

Author

Kulkarni, Prasad S., primary, Kadam, Abhijit, additional, Godbole, Sheela, additional, Bhatt, Varsha, additional, Raut, Abhishek, additional, Kohli, Sunil, additional, Tripathi, Santanu, additional, Kulkarni, Praveen, additional, Ludam, Rakhi, additional, Prabhu, Madhav, additional, Bavdekar, Ashish, additional, Gogtay, Nithya J., additional, Meshram, Sushant, additional, Kadhiravan, Tamilarasu, additional, Kar, Sonali, additional, Narayana, Ashwath, additional, Samuel, Clarence, additional, Kulkarni, Govind, additional, Gaidhane, Abhay, additional, Sathyapalan, Dipu, additional, Raut, Sidram, additional, Hadda, Vijay, additional, Bhalla, Hira Lal, additional, Bhamare, Chetanraj, additional, Dharmadhikari, Abhijeet, additional, Plested, Joyce, additional, Cloney-Clarke, Shane, additional, Zhu, Mingzhu, additional, Pryor, Melinda, additional, Thakar, Madhuri, additional, Shete, Ashwini, additional, Gautam, Manish, additional, Gupta, Nivedita, additional, Panda, Samiran, additional, Shaligram, Umesh, additional, Poonawalla, Cyrus, additional, Bhargava, Balram, additional, Gunale, Bhagwat, additional, Kapse, Dhananjay, additional, and Study Group, for the COVOVAX, additional

Published
2022
Full Text
View/download PDF

40. Scalable, methanol‐free manufacturing of the SARS‐CoV‐2 receptor‐binding domain in engineered Komagataella phaffii

Author

Dalvie, Neil C., primary, Biedermann, Andrew M., additional, Rodriguez‐Aponte, Sergio A., additional, Naranjo, Christopher A., additional, Rao, Harish D., additional, Rajurkar, Meghraj P., additional, Lothe, Rakesh R., additional, Shaligram, Umesh S., additional, Johnston, Ryan S., additional, Crowell, Laura E., additional, Castelino, Seraphin, additional, Tracey, Mary K., additional, Whittaker, Charles A., additional, and Love, J. Christopher, additional

Published
2021
Full Text
View/download PDF

43. Efficacy of a low-dose candidate malaria vaccine, R21 in adjuvant Matrix-M, with seasonal administration to children in Burkina Faso: a randomised controlled trial.

Author

Datoo, Mehreen MS, Natama, Hamtandi Magloire, Somé, Athanase, Traoré, Ousmane, Rouamba, Toussaint, Bellamy, Duncan, Yameogo, Prisca, Valia, Daniel, Tegneri, Moubarak, Ouedraogo, Florence, Soma, Rachidatou, Sawadogo, Seydou, Sorgho, Faizatou, Derra, Karim, Rouamba, Eli, Orindi, Benedict, Ramos Lopez, Fernando, Flaxman, Amy, Cappuccini, Federica, Kailath, Reshma, Elias, Sean, Mukhopadhyay, Ekta, Noe, Andres, Cairns, Matthew, Lawrie, Alison, Roberts, Rachel, Valéa, Innocent, Sorgho, Hermann, Williams, Nicola, Glenn, Gregory, Fries, Louis, Reimer, Jenny, Ewer, Katie KJ, Shaligram, Umesh, Hill, Adrian V S, Tinto, Halidou, Datoo, Mehreen MS, Natama, Hamtandi Magloire, Somé, Athanase, Traoré, Ousmane, Rouamba, Toussaint, Bellamy, Duncan, Yameogo, Prisca, Valia, Daniel, Tegneri, Moubarak, Ouedraogo, Florence, Soma, Rachidatou, Sawadogo, Seydou, Sorgho, Faizatou, Derra, Karim, Rouamba, Eli, Orindi, Benedict, Ramos Lopez, Fernando, Flaxman, Amy, Cappuccini, Federica, Kailath, Reshma, Elias, Sean, Mukhopadhyay, Ekta, Noe, Andres, Cairns, Matthew, Lawrie, Alison, Roberts, Rachel, Valéa, Innocent, Sorgho, Hermann, Williams, Nicola, Glenn, Gregory, Fries, Louis, Reimer, Jenny, Ewer, Katie KJ, Shaligram, Umesh, Hill, Adrian V S, and Tinto, Halidou

Abstract

Stalled progress in controlling Plasmodium falciparum malaria highlights the need for an effective and deployable vaccine. RTS,S/AS01, the most effective malaria vaccine candidate to date, demonstrated 56% efficacy over 12 months in African children. We therefore assessed a new candidate vaccine for safety and efficacy., info:eu-repo/semantics/published

Published
2021

45. High Efficacy of a Low Dose Candidate Malaria Vaccine, R21 in 1 Adjuvant Matrix-M™, with Seasonal Administration to Children in Burkina Faso

Author

Datoo, Mehreen S., primary, Magloire Natama, Hamtandi, additional, Somé, Athanase, additional, Traoré, Ousmane, additional, Rouamba, Toussaint, additional, Bellamy, Duncan, additional, Yameogo, Prisca, additional, Valia, Daniel, additional, Tegneri, Moubarak, additional, Ouedraogo, Florence, additional, Soma, Rachidatou, additional, Sawadogo, Seydou, additional, Sorgho, Faizatou, additional, Derra, Karim, additional, Rouamba, Eli, additional, Orindi, Benedict, additional, Ramos-Lopez, Fernando, additional, Flaxman, Amy, additional, Cappuccini, Federica, additional, Kailath, Reshma, additional, Elias, Sean C., additional, Mukhopadhyay, Ekta, additional, Noe, Andres, additional, Cairns, Matthew, additional, Lawrie, Alison, additional, Roberts, Rachel, additional, Valéa, Innocent, additional, Sorgho, Hermann, additional, Williams, Nicola, additional, Glenn, Gregory, additional, Fries, Louis, additional, Reimer, Jenny, additional, Ewer, Katie J., additional, Shaligram, Umesh, additional, Hill, Adrian V. S., additional, and Tinto, Halidou, additional

Published
2021
Full Text
View/download PDF

46. A Phase 2/3, Observer-Blind, Randomised, Controlled Study to Assess the Safety and Immunogenicity of SII-ChAdOx1 nCOV-19 (COVID-19 Vaccine) in Adults in India

Author

Kulkarni, Prasad S., primary, Padmapriyadarshini, Chandrasekaran, additional, Vekemans, Johan, additional, Bavdekar, Ashish, additional, Gupta, Madhu, additional, Kulkarni, Praveen, additional, Garg, B. S., additional, Gogtay, Nithya J., additional, Tambe, Muralidhar, additional, Lalwani, Sanjay, additional, Singh, Kiranjit, additional, Munshi, Renuka, additional, Meshram, Sushant, additional, Selvavinayagam, T. S., additional, Pandey, Krishna, additional, Bhimarasetty, Devi Madhavi, additional, Ramakrishnan, S. R., additional, Bhamare, Chetanraj, additional, Dharmadhikari, Abhijeet, additional, Vadakkedath, Rajeev, additional, Bonhomme, Cyrille J., additional, Thakar, Madhuri, additional, Kurle, Swarali N., additional, Kelly, Elizabeth J., additional, Gautam, Manish, additional, Gupta, Nivedita, additional, Panda, Samiran, additional, Bhargava, Balram, additional, Shaligram, Umesh, additional, Kapse, Dhananjay, additional, Gunale, Bhagwat, additional, and Group, COVISHIELD Study, additional

Published
2021
Full Text
View/download PDF

47. Results of the phase I open label clinical trial SAKK 06/14 assessing safety of intravesical instillation of VPM1002BC, a recombinant mycobacterium Bacillus Calmette Guérin (BCG), in patients with non-muscle invasive bladder cancer and previous failure of conventional BCG therapy

Author

Rentsch, Cyrill A., primary, Bosshard, Piet, additional, Mayor, Grégoire, additional, Rieken, Malte, additional, Püschel, Heike, additional, Wirth, Grégory, additional, Cathomas, Richard, additional, Parzmair, Gerald P., additional, Grode, Leander, additional, Eisele, Bernd, additional, Sharma, Hitt, additional, Gupta, Manish, additional, Gairola, Sunil, additional, Shaligram, Umesh, additional, Goldenberger, Daniel, additional, Spertini, François, additional, Audran, Régine, additional, Enoiu, Milica, additional, Berardi, Simona, additional, Hayoz, Stefanie, additional, and Wicki, Andreas, additional

Published
2020
Full Text
View/download PDF

48. Scalable, methanol‐free manufacturing of the SARS‐CoV‐2 receptor‐binding domain in engineered Komagataella phaffii.

Author

Dalvie, Neil C., Biedermann, Andrew M., Rodriguez‐Aponte, Sergio A., Naranjo, Christopher A., Rao, Harish D., Rajurkar, Meghraj P., Lothe, Rakesh R., Shaligram, Umesh S., Johnston, Ryan S., Crowell, Laura E., Castelino, Seraphin, Tracey, Mary K., Whittaker, Charles A., and Love, J. Christopher

Abstract

Prevention of COVID‐19 on a global scale will require the continued development of high‐volume, low‐cost platforms for the manufacturing of vaccines to supply ongoing demand. Vaccine candidates based on recombinant protein subunits remain important because they can be manufactured at low costs in existing large‐scale production facilities that use microbial hosts like Komagataella phaffii (Pichia pastoris). Here, we report an improved and scalable manufacturing approach for the SARS‐CoV‐2 spike protein receptor‐binding domain (RBD); this protein is a key antigen for several reported vaccine candidates. We genetically engineered a manufacturing strain of K. phaffii to obviate the requirement for methanol induction of the recombinant gene. Methanol‐free production improved the secreted titer of the RBD protein by >5X by alleviating protein folding stress. Removal of methanol from the production process enabled to scale up to a 1200 L pre‐existing production facility. This engineered strain is now used to produce an RBD‐based vaccine antigen that is currently in clinical trials and could be used to produce other variants of RBD as needed for future vaccines. [ABSTRACT FROM AUTHOR]

Published
2022
Full Text
View/download PDF

49. Genome Sequence of Bordetella pertussis Vaccine Strain BP 165

Author

Alai, Shweta, primary, Ghattargi, Vikas C., additional, Gautam, Manish, additional, Dhotre, Dhiraj P., additional, Patel, Krunal, additional, Pawar, Shrikant P., additional, Kumar, Rakesh, additional, Shaligram, Umesh, additional, Deobagkar, Deepti, additional, and Gairola, Sunil, additional

Published
2019
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results