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1. The Global Retinoblastoma Outcome Study: a prospective, cluster-based analysis of 4064 patients from 149 countries

Author

Alia, DB, Tandili, A, Paiva, L, Wime, AD, Chantada, GL, Fandino, AC, Sgroi, M, Papyan, R, Tamamyan, G, Camuglia, JE, Gole, GA, Clark, A, Lam, GC, Elder, JE, McKenzie, JD, Staffieri, SE, Jones, MM, Manudhane, R, Sia, D, Ritter-Sovinz, P, Schwab, C, Balayeva, R, Khan, Z, Nuruddin, M, Roy, SR, Rashid, R, Sultana, S, Shakoor, SA, Naumenko, L, Zhilyaeva, K, Bartoszek, P, Brichard, BG, De Potter, P, Bio, AIA, Salas, B, Coleoni Suarez, ME, Mbumba, FB, Bonanomi, MTBC, Donato Macedo, CR, Grigorovski, NDAK, Mattosinho, CCDS, Teixeira, LF, Oscar, AH, Veleva-Krasteva, NV, Bouda, GC, Kabore, RL, Philbert, R, Evina, TGA, Nkumbe, HE, Kamsang, P, Muyen, OM, Dimaras, H, Mallipatna, A, Hamel, P, Superstein, R, Paton, KE, Strahlendorf, C, Palet, JEKK, Tyau-Tyau, H, Cavieres, I, Lopez, JP, Oporto, J, Ossandon, D, Chen, W, Xiang, D, Du, Y, Li, K, Ji, X, Tang, J, Li, C, Xu, B, Qian, J, Xue, K, Sun, X, Wang, Y-Z, Zhang, Y, Wu, S-Q, Xiao, Y, Yang, H, Ye, H, Polania, RA, Berete, RC, Couitchere, L, Peric, S, Alemany-Rubio, E, Gonzalez-Rodriguez, L, Autrata, R, Kepak, T, Pochop, P, Svojgr, K, Gregersen, PA, Urbak, SF, Montero, MM, Budiongo, A, Yanga, JM, Amani, TBK, Lukamba, RM, Numbi, MN, Calle Jara, DA, Villacis Chafla, EG, Sanchez, GL, Abouelnaga, S, Afifi, MA, Elhaddad, AM, Ali, AM, Elzembely, M, Said, AMA, Ziko, OAO, Fuentes-Alabi, SL, Goenz, MA, Eerme, K, Klett, A, Hordofa, DF, Mengesha, AA, Sherief, ST, Kivela, TT, Nummi, K, Cassoux, N, Desjardins, L, Obono-Obiang, G, Kardava, T, Khotenashvili, Z, Bechrakis, NE, Biewald, EM, Schlueter, S, Ketteler, P, Amankwaa-Frempong, D, Essuman, VA, Paintsil, V, Renner, LA, Alejos, A, Giron, A, Carreras, YA, Fu, LD, Maldonado, C, Wong, ES, Yam, JC, Csoka, M, Maka, E, Aggarwal, P, Gupta, V, Bhaduri, A, Bhattacharyya, A, Das, A, Chawla, B, Das, P, Das, S, Gupta, H, Gupta, S, Verma, N, Kaliki, S, Khetan, V, Maitra, P, Mahajan, A, Menon, V, Mishra, DKC, Palanivelu, MS, Ramanjulu, R, Mudaliar, SS, Nair, AG, Natarajan, S, Seth, R, Singh, U, Bhat, S, Dudeja, G, Tripathy, D, Akib, IMNR, Pagarra, H, Amiruddin, PO, Kuntorini, MW, Armytasari, I, Supriyadi, E, Sutyawan, IWE, Yuliawati, P, Lutfi, D, Soebagjo, HD, Rahman, A, Sitorus, RS, Victor, AA, Tehuteru, ES, Widiarti, W, Nency, YM, Faranoush, M, Mehrvar, A, Tashvighi, M, Sedaghat, A, Ghassemi, F, Khodabande, A, Abdulqader, RA, Al-Shaheen, AASM, Al Ani, MH, Haydar, H, Al-Badri, SAF, Al-Jadiry, MF, Sabhan, AH, Al-Jumaily, U, Al-Mafrachi, AARM, Al-Shammary, EH, Al-Janabi, ANH, Qadir, AO, Capra, M, Blum, S, Gomel, N, Fabian, ID, Goldberg, H, Kapelushnik, N, Madgar, S, Vishnevskia-Dai, V, Frenkel, S, Pe'er, J, Gorfine, M, Refaeli, D, Steinberg, DM, Lavy, Y, Toledano, H, Caspi, S, De Francesco, S, Hadjistilianou, T, Ida, R, Valente, P, Midena, E, Parrozzani, R, Cowan-Lyn, KE, Vaughan, LO, Suzuki, S, Mohammad, MT, Yousef, YA, Manzhuova, L, Atsiaya, R, Matende, IO, Begimkulova, AS, Makimbetov, EK, Keomisy, J, Sayalith, P, Valeina, S, Viksnins, M, Al-Haddad, CE, Saab, RH, Alsawidi, KM, Elbahi, AM, Krivaitiene, D, Tateshi, B, Randrianarisoa, HL, Raobela, L, Msukwa, G, Nyirenda, C, Hamzah, N, Teh, KH, Sylla, F, Traore, F, Cheikh, SS, Zein, E, Perez, GG, Sanchez Orozco, AJ, Ortega-Hernandez, M, Ramirez-Ortiz, MA, Chuluunbat, T, Abdallah, E, Benmiloud, S, El Kettani, A, Hessissen, L, Almeida, AA, Limbu, B, Rajkarnikar, P, Saiju, R, Moll, AC, Wijsard, MVH, Cockcroft, RL, Ng, Y, Dodgshun, AJ, Calderon-Sotelo, P, Abdullahi, SU, Hassan, S, Umar, AB, Abdulrahaman, AA, Wali, AH, Ademola-Popoola, DS, Adio, A, Aghaji, AE, Ezegwui, IR, Akinsete, A, Musa, KO, Fasina, O, Ibanga, A, Nkanga, ED, Mustapha, T, Ribadu, D, Hummelen, M, Ahmad, A, Mushtaq, A, Qayyum, S, Chaudhry, S, Fadoo, Z, Jeeva, I, Masud, S, Hamid, SA, Zia, N, Siddiqui, SN, Janjua, T, Yaqub, MA, Khaqan, HA, Quintero D, K, Yee, R, Jairaj, V, Cano, MR, Fernandez, DDPG, Diaz Coronado, RY, Zapata Lopez, AM, Garcia, JL, Ponce, J, Garcia Pacheco, HN, Pascual Morales, CR, Vasquez Anchaya, JK, Tarrillo Leiva, FF, Alcasabas, APA, Mercado, GJ, Cieslik, K, Hautz, W, Rogowska, A, Castela, G, Silva, S, Jo, DH, Kim, JH, Comsa, C, Dragomir, MD, Neroev, V, Saakyan, S, Polyakov, V, Ushakova, TL, Yarovaya, VA, Yarovoy, AA, Theophile, T, Al Mesfer, S, Maktabi, A, Al-Dahmash, SA, Alkatan, HM, Moreira, C, Roth, PAN, Ilic, VR, Nikitovic, M, Latinovic, S, Quah, B, Tan, D, Hederova, S, Husakova, K, Groznik, AL, Pompe, MT, Davidson, A, Du Bruyn, M, Du Plessis, J, Stones, DK, Geel, JA, Myezo, KH, Kruger, M, Mayet, I, Naidu, G, Naidu, N, Mustak, H, Reynders, D, Wetter, J, Alarcon Portabella, S, Martin-Begue, N, Wolley Dod, C, Balaguer, J, Barranco, H, Catala-Mora, J, Correa Llano, MG, Fernandez-Teijeiro, A, Garcia Aldana, D, Peralta Calvo, J, San Roman Pacheco, S, Gunasekera, DS, Elhassan, MMA, Mohamedani, AA, All-Eriksson, C, Bartuma, K, Popovic, MB, Munier, FL, Liu, C-H, Chiwanga, FS, Kyara, A, Mndeme, FG, Msina, MS, Scanlan, TA, Atchaneeyasakul, L-O, Buaboonnam, J, Dangboon, W, Singha, P, Hongeng, S, Kulvichit, K, Rojanaporn, D, Surukrattanaskul, S, Wangtiraumnuay, N, Wiwatwongwana, A, Wiwatwongwana, D, Wongwai, P, Sharma, MK, Guedenon, KM, Bouguila, H, Atalay, HT, Hasanreisoglu, M, Ataseven, E, Kantar, M, Gunduz, AK, Kebudi, R, Kiratli, H, Koc, I, Tuncer, S, Unal, E, Kalinaki, A, Matua, M, Waddell, K, Musika, AA, Ssali, G, Al Harby, L, Reddy, MA, Astbury, NJ, Bascaran, C, Bowman, R, Burton, MJ, Foster, A, Zondervan, M, Sagoo, MS, Bobrova, N, Sorochynska, T, Lysytsia, L, Castillo, L, Afshar, AR, Berry, JL, Kim, JW, Randhawa, JK, Binkley, E, Boldt, HC, Larson, SA, Brennan, RC, Chandramohan, A, Stacey, AW, Corson, TW, Plager, DA, Davanzo, JM, Singh, AD, Demirci, H, Ericksen, C, Magrath, GN, Gold, AS, Murray, TG, Gonzalez, E, Shah, AS, Hansen, ED, Hartnett, ME, Harbour, JW, Hubbard, GB, Uner, OE, Laurenti, KD, Mets, MB, Leverant, AA, Ramasubramanian, A, Luna-Fineman, S, Miller, A, Skalet, AH, Mruthyunjaya, P, Hassan, M, Oliver, SC, Shields, CL, Yaghy, A, Stahl, ED, Wilson, MW, Villegas, VM, Islamov, Z, Usmanov, RH, Graells, J, Romero, L, Pham, CTM, Trang, DL, Al-Hussaini, HH, Thawaba, ADM, Muma, KIM, Nyaywa, M, Alia, DB, Tandili, A, Paiva, L, Wime, AD, Chantada, GL, Fandino, AC, Sgroi, M, Papyan, R, Tamamyan, G, Camuglia, JE, Gole, GA, Clark, A, Lam, GC, Elder, JE, McKenzie, JD, Staffieri, SE, Jones, MM, Manudhane, R, Sia, D, Ritter-Sovinz, P, Schwab, C, Balayeva, R, Khan, Z, Nuruddin, M, Roy, SR, Rashid, R, Sultana, S, Shakoor, SA, Naumenko, L, Zhilyaeva, K, Bartoszek, P, Brichard, BG, De Potter, P, Bio, AIA, Salas, B, Coleoni Suarez, ME, Mbumba, FB, Bonanomi, MTBC, Donato Macedo, CR, Grigorovski, NDAK, Mattosinho, CCDS, Teixeira, LF, Oscar, AH, Veleva-Krasteva, NV, Bouda, GC, Kabore, RL, Philbert, R, Evina, TGA, Nkumbe, HE, Kamsang, P, Muyen, OM, Dimaras, H, Mallipatna, A, Hamel, P, Superstein, R, Paton, KE, Strahlendorf, C, Palet, JEKK, Tyau-Tyau, H, Cavieres, I, Lopez, JP, Oporto, J, Ossandon, D, Chen, W, Xiang, D, Du, Y, Li, K, Ji, X, Tang, J, Li, C, Xu, B, Qian, J, Xue, K, Sun, X, Wang, Y-Z, Zhang, Y, Wu, S-Q, Xiao, Y, Yang, H, Ye, H, Polania, RA, Berete, RC, Couitchere, L, Peric, S, Alemany-Rubio, E, Gonzalez-Rodriguez, L, Autrata, R, Kepak, T, Pochop, P, Svojgr, K, Gregersen, PA, Urbak, SF, Montero, MM, Budiongo, A, Yanga, JM, Amani, TBK, Lukamba, RM, Numbi, MN, Calle Jara, DA, Villacis Chafla, EG, Sanchez, GL, Abouelnaga, S, Afifi, MA, Elhaddad, AM, Ali, AM, Elzembely, M, Said, AMA, Ziko, OAO, Fuentes-Alabi, SL, Goenz, MA, Eerme, K, Klett, A, Hordofa, DF, Mengesha, AA, Sherief, ST, Kivela, TT, Nummi, K, Cassoux, N, Desjardins, L, Obono-Obiang, G, Kardava, T, Khotenashvili, Z, Bechrakis, NE, Biewald, EM, Schlueter, S, Ketteler, P, Amankwaa-Frempong, D, Essuman, VA, Paintsil, V, Renner, LA, Alejos, A, Giron, A, Carreras, YA, Fu, LD, Maldonado, C, Wong, ES, Yam, JC, Csoka, M, Maka, E, Aggarwal, P, Gupta, V, Bhaduri, A, Bhattacharyya, A, Das, A, Chawla, B, Das, P, Das, S, Gupta, H, Gupta, S, Verma, N, Kaliki, S, Khetan, V, Maitra, P, Mahajan, A, Menon, V, Mishra, DKC, Palanivelu, MS, Ramanjulu, R, Mudaliar, SS, Nair, AG, Natarajan, S, Seth, R, Singh, U, Bhat, S, Dudeja, G, Tripathy, D, Akib, IMNR, Pagarra, H, Amiruddin, PO, Kuntorini, MW, Armytasari, I, Supriyadi, E, Sutyawan, IWE, Yuliawati, P, Lutfi, D, Soebagjo, HD, Rahman, A, Sitorus, RS, Victor, AA, Tehuteru, ES, Widiarti, W, Nency, YM, Faranoush, M, Mehrvar, A, Tashvighi, M, Sedaghat, A, Ghassemi, F, Khodabande, A, Abdulqader, RA, Al-Shaheen, AASM, Al Ani, MH, Haydar, H, Al-Badri, SAF, Al-Jadiry, MF, Sabhan, AH, Al-Jumaily, U, Al-Mafrachi, AARM, Al-Shammary, EH, Al-Janabi, ANH, Qadir, AO, Capra, M, Blum, S, Gomel, N, Fabian, ID, Goldberg, H, Kapelushnik, N, Madgar, S, Vishnevskia-Dai, V, Frenkel, S, Pe'er, J, Gorfine, M, Refaeli, D, Steinberg, DM, Lavy, Y, Toledano, H, Caspi, S, De Francesco, S, Hadjistilianou, T, Ida, R, Valente, P, Midena, E, Parrozzani, R, Cowan-Lyn, KE, Vaughan, LO, Suzuki, S, Mohammad, MT, Yousef, YA, Manzhuova, L, Atsiaya, R, Matende, IO, Begimkulova, AS, Makimbetov, EK, Keomisy, J, Sayalith, P, Valeina, S, Viksnins, M, Al-Haddad, CE, Saab, RH, Alsawidi, KM, Elbahi, AM, Krivaitiene, D, Tateshi, B, Randrianarisoa, HL, Raobela, L, Msukwa, G, Nyirenda, C, Hamzah, N, Teh, KH, Sylla, F, Traore, F, Cheikh, SS, Zein, E, Perez, GG, Sanchez Orozco, AJ, Ortega-Hernandez, M, Ramirez-Ortiz, MA, Chuluunbat, T, Abdallah, E, Benmiloud, S, El Kettani, A, Hessissen, L, Almeida, AA, Limbu, B, Rajkarnikar, P, Saiju, R, Moll, AC, Wijsard, MVH, Cockcroft, RL, Ng, Y, Dodgshun, AJ, Calderon-Sotelo, P, Abdullahi, SU, Hassan, S, Umar, AB, Abdulrahaman, AA, Wali, AH, Ademola-Popoola, DS, Adio, A, Aghaji, AE, Ezegwui, IR, Akinsete, A, Musa, KO, Fasina, O, Ibanga, A, Nkanga, ED, Mustapha, T, Ribadu, D, Hummelen, M, Ahmad, A, Mushtaq, A, Qayyum, S, Chaudhry, S, Fadoo, Z, Jeeva, I, Masud, S, Hamid, SA, Zia, N, Siddiqui, SN, Janjua, T, Yaqub, MA, Khaqan, HA, Quintero D, K, Yee, R, Jairaj, V, Cano, MR, Fernandez, DDPG, Diaz Coronado, RY, Zapata Lopez, AM, Garcia, JL, Ponce, J, Garcia Pacheco, HN, Pascual Morales, CR, Vasquez Anchaya, JK, Tarrillo Leiva, FF, Alcasabas, APA, Mercado, GJ, Cieslik, K, Hautz, W, Rogowska, A, Castela, G, Silva, S, Jo, DH, Kim, JH, Comsa, C, Dragomir, MD, Neroev, V, Saakyan, S, Polyakov, V, Ushakova, TL, Yarovaya, VA, Yarovoy, AA, Theophile, T, Al Mesfer, S, Maktabi, A, Al-Dahmash, SA, Alkatan, HM, Moreira, C, Roth, PAN, Ilic, VR, Nikitovic, M, Latinovic, S, Quah, B, Tan, D, Hederova, S, Husakova, K, Groznik, AL, Pompe, MT, Davidson, A, Du Bruyn, M, Du Plessis, J, Stones, DK, Geel, JA, Myezo, KH, Kruger, M, Mayet, I, Naidu, G, Naidu, N, Mustak, H, Reynders, D, Wetter, J, Alarcon Portabella, S, Martin-Begue, N, Wolley Dod, C, Balaguer, J, Barranco, H, Catala-Mora, J, Correa Llano, MG, Fernandez-Teijeiro, A, Garcia Aldana, D, Peralta Calvo, J, San Roman Pacheco, S, Gunasekera, DS, Elhassan, MMA, Mohamedani, AA, All-Eriksson, C, Bartuma, K, Popovic, MB, Munier, FL, Liu, C-H, Chiwanga, FS, Kyara, A, Mndeme, FG, Msina, MS, Scanlan, TA, Atchaneeyasakul, L-O, Buaboonnam, J, Dangboon, W, Singha, P, Hongeng, S, Kulvichit, K, Rojanaporn, D, Surukrattanaskul, S, Wangtiraumnuay, N, Wiwatwongwana, A, Wiwatwongwana, D, Wongwai, P, Sharma, MK, Guedenon, KM, Bouguila, H, Atalay, HT, Hasanreisoglu, M, Ataseven, E, Kantar, M, Gunduz, AK, Kebudi, R, Kiratli, H, Koc, I, Tuncer, S, Unal, E, Kalinaki, A, Matua, M, Waddell, K, Musika, AA, Ssali, G, Al Harby, L, Reddy, MA, Astbury, NJ, Bascaran, C, Bowman, R, Burton, MJ, Foster, A, Zondervan, M, Sagoo, MS, Bobrova, N, Sorochynska, T, Lysytsia, L, Castillo, L, Afshar, AR, Berry, JL, Kim, JW, Randhawa, JK, Binkley, E, Boldt, HC, Larson, SA, Brennan, RC, Chandramohan, A, Stacey, AW, Corson, TW, Plager, DA, Davanzo, JM, Singh, AD, Demirci, H, Ericksen, C, Magrath, GN, Gold, AS, Murray, TG, Gonzalez, E, Shah, AS, Hansen, ED, Hartnett, ME, Harbour, JW, Hubbard, GB, Uner, OE, Laurenti, KD, Mets, MB, Leverant, AA, Ramasubramanian, A, Luna-Fineman, S, Miller, A, Skalet, AH, Mruthyunjaya, P, Hassan, M, Oliver, SC, Shields, CL, Yaghy, A, Stahl, ED, Wilson, MW, Villegas, VM, Islamov, Z, Usmanov, RH, Graells, J, Romero, L, Pham, CTM, Trang, DL, Al-Hussaini, HH, Thawaba, ADM, Muma, KIM, and Nyaywa, M

Abstract

BACKGROUND: Retinoblastoma is the most common intraocular cancer worldwide. There is some evidence to suggest that major differences exist in treatment outcomes for children with retinoblastoma from different regions, but these differences have not been assessed on a global scale. We aimed to report 3-year outcomes for children with retinoblastoma globally and to investigate factors associated with survival. METHODS: We did a prospective cluster-based analysis of treatment-naive patients with retinoblastoma who were diagnosed between Jan 1, 2017, and Dec 31, 2017, then treated and followed up for 3 years. Patients were recruited from 260 specialised treatment centres worldwide. Data were obtained from participating centres on primary and additional treatments, duration of follow-up, metastasis, eye globe salvage, and survival outcome. We analysed time to death and time to enucleation with Cox regression models. FINDINGS: The cohort included 4064 children from 149 countries. The median age at diagnosis was 23·2 months (IQR 11·0-36·5). Extraocular tumour spread (cT4 of the cTNMH classification) at diagnosis was reported in five (0·8%) of 636 children from high-income countries, 55 (5·4%) of 1027 children from upper-middle-income countries, 342 (19·7%) of 1738 children from lower-middle-income countries, and 196 (42·9%) of 457 children from low-income countries. Enucleation surgery was available for all children and intravenous chemotherapy was available for 4014 (98·8%) of 4064 children. The 3-year survival rate was 99·5% (95% CI 98·8-100·0) for children from high-income countries, 91·2% (89·5-93·0) for children from upper-middle-income countries, 80·3% (78·3-82·3) for children from lower-middle-income countries, and 57·3% (52·1-63·0) for children from low-income countries. On analysis, independent factors for worse survival were residence in low-income countries compared to high-income countries (hazard ratio 16·67; 95% CI 4·76-50·00), cT4 advanced tumour compared to

Published
2022

3. AZD3152 neutralizes SARS-CoV-2 historical and contemporary variants and is protective in hamsters and well tolerated in adults.

Author

Cai Y, Diallo S, Rosenthal K, Ren K, Flores DJ, Dippel A, Oganesyan V, van Dyk N, Chen X, Cantu E, Choudhary R, Sulikowski M, Adissu H, Chawla B, Kar S, Liu C, Dijokaite-Guraliuc A, Mongkolsapaya J, Rajan S, Loo YM, Beavon R, Webber C, Chang LJ, Thomas S, Clegg L, Zhang H, Screaton GR, Philbin N, Harre M, Selim A, Martinez-Alier N, Uriel A, Cohen TS, Perez JL, Esser MT, Blair W, and Francica JR

Subjects
Animals, Humans, Cricetinae, COVID-19 Drug Treatment, Antibodies, Monoclonal, Humanized pharmacology, Antibodies, Monoclonal, Humanized therapeutic use, Antibodies, Monoclonal, Humanized pharmacokinetics, Mesocricetus, Female, Male, Adult, Antibodies, Viral immunology, Mutation genetics, Antibodies, Monoclonal, Angiotensin-Converting Enzyme 2 metabolism, Viral Load drug effects, SARS-CoV-2 drug effects, COVID-19 virology, Antibodies, Neutralizing immunology, Spike Glycoprotein, Coronavirus metabolism
Abstract

The evolution of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has resulted in variants that can escape neutralization by therapeutic antibodies. Here, we describe AZD3152, a SARS-CoV-2-neutralizing monoclonal antibody designed to provide improved potency and coverage against emerging variants. AZD3152 binds to the back left shoulder of the SARS-CoV-2 spike protein receptor binding domain and prevents interaction with the human angiotensin-converting enzyme 2 receptor. AZD3152 potently neutralized a broad panel of pseudovirus variants, including the currently dominant Omicron variant JN.1 but has reduced potency against XBB subvariants containing F456L. In vitro studies confirmed F456L resistance and additionally identified T415I and K458E as escape mutations. In a Syrian hamster challenge model, prophylactic administration of AZD3152 protected hamsters from weight loss and inflammation-related lung pathologies and reduced lung viral load. In the phase 1 sentinel safety cohort of the ongoing SUPERNOVA study (ClinicalTrials.gov: NCT05648110), a single 600-mg intramuscular injection of AZD5156 (containing 300 mg each of AZD3152 and cilgavimab) was well tolerated in adults through day 91. Observed serum concentrations of AZD3152 through day 91 were similar to those observed with cilgavimab and consistent with predictions for AZD7442, a SARS-CoV-2-neutralizing antibody combination of cilgavimab and tixagevimab, in a population pharmacokinetic model. On the basis of its pharmacokinetic characteristics, AZD3152 is predicted to provide durable protection against symptomatic coronavirus disease 2019 caused by susceptible SARS-CoV-2 variants, such as JN.1, in humans.

Published
2024
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4. Adjuvanted subunit intranasal vaccine prevents SARS-CoV-2 onward transmission in hamsters.

Author

Sui Y, Kar S, Chawla B, Hoang T, Yu Y, Wallace SM, Andersen H, and Berzofsky JA

Abstract

Most COVID-19 vaccine trials have focused on recipient protection, not protection of their contacts, a critical need. As a subunit intranasal COVID-19 vaccine reduced nasopharyngeal virus more than did an intramuscular (IM) vaccine, we hypothesized that this vaccine might reduce onward transmission to others. We vaccinated hamsters with either the IM-administrated Moderna mRNA vaccine twice or one dose of mRNA IM followed by adjuvanted subunit intranasal vaccine. 24 hours after SARS-CoV-2 challenge, these animals were housed with naïve recipients in a contactless chamber that allows airborne transmission. Onward airborne transmission was profoundly blocked: the donor and recipients of the intranasal vaccine-boosted group had lower oral and lung viral loads (VL), which correlated with mucosal ACE2 inhibition activity. These data strongly support the use of the intranasal vaccine as a boost to protect not only the vaccinated person, but also people exposed to the vaccinated person, a key public health goal., Author Summary: Natural transmission of SARS-CoV-2 is primarily airborne, through the respiratory mucosal route. However, current licensed COVID-19 vaccines are all intramuscular and induce more systemic than mucosal immunity. Here, we did a head-to-head comparison of COVID-19 booster vaccines on SARS-CoV-2 onward transmission. We found that compared to boosting with a Moderna mRNA systemic vaccine, a nanoparticle intranasal COVID-19 vaccine much more effectively prevents onward airborne transmission to naïve recipient hamsters. The protection was correlated with local mucosal antibody. Thus, a mucosal nanoparticle vaccine should be considered for preventing onward airborne transmission, a key public health necessity that has not been adequately studied.

Published
2024
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5. Retinoblastoma in Asia: Clinical Presentation and Treatment Outcomes in 2112 Patients from 33 Countries.

Author

Kaliki S, Vempuluru VS, Mohamed A, Al-Jadiry MF, Bowman R, Chawla B, Hamid SA, Ji X, Kapelushnik N, Kebudi R, Sthapit PR, Rojanaporn D, Sitorus RS, Yousef YA, and Fabian ID

Subjects
Child, Humans, Male, Female, Infant, Child, Preschool, Prospective Studies, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Treatment Outcome, Asia epidemiology, Retrospective Studies, Eye Enucleation, Retinoblastoma diagnosis, Retinoblastoma epidemiology, Retinoblastoma therapy, Retinal Neoplasms diagnosis, Retinal Neoplasms epidemiology, Retinal Neoplasms therapy
Abstract

Purpose: To describe the clinical presentation and treatment outcomes of children who received a diagnosis of retinoblastoma in 2017 throughout Asia., Design: Multinational, prospective study including treatment-naïve patients in Asia who received a diagnosis of retinoblastoma in 2017 and were followed up thereafter., Participants: A total of 2112 patients (2797 eyes) from 96 retinoblastoma treatment centers in 33 Asian countries., Interventions: Chemotherapy, radiotherapy, enucleation, and orbital exenteration., Main Outcome Measures: Enucleation and death., Results: Within the cohort, 1021 patients (48%) were from South Asia (SA), 503 patients (24%) were from East Asia (EA), 310 patients (15%) were from Southeast Asia (SEA), 218 patients (10%) were from West Asia (WA), and 60 patients (3%) were from Central Asia (CA). Mean age at presentation was 27 months (median, 23 months; range, < 1-261 months). The cohort included 1195 male patients (57%) and 917 female patients (43%). The most common presenting symptoms were leukocoria (72%) and strabismus (13%). Using the American Joint Committee on Cancer Staging Manual, Eighth Edition, classification, tumors were staged as cT1 (n = 441 [16%]), cT2 (n = 951 [34%]), cT3 (n = 1136 [41%]), cT4 (n = 267 [10%]), N1 (n = 48 [2%]), and M1 (n = 129 [6%]) at presentation. Retinoblastoma was treated with intravenous chemotherapy in 1450 eyes (52%) and 857 eyes (31%) underwent primary enucleation. Three-year Kaplan-Meier estimates for enucleation and death were 33% and 13% for CA, 18% and 4% for EA, 27% and 15% for SA, 32% and 22% for SEA, and 20% and 11% for WA (P < 0.0001 and P < 0.0001), respectively., Conclusions: At the conclusion of this study, significant heterogeneity was found in treatment outcomes of retinoblastoma among the regions of Asia. East Asia displayed better outcomes with higher rates of globe and life salvage, whereas Southeast Asia showed poorer outcomes compared with the rest of Asia., Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article., (Copyright © 2023 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Published
2024
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6. A multivalent mRNA monkeypox virus vaccine (BNT166) protects mice and macaques from orthopoxvirus disease.

Author

Zuiani A, Dulberger CL, De Silva NS, Marquette M, Lu YJ, Palowitch GM, Dokic A, Sanchez-Velazquez R, Schlatterer K, Sarkar S, Kar S, Chawla B, Galeev A, Lindemann C, Rothenberg DA, Diao H, Walls AC, Addona TA, Mensa F, Vogel AB, Stuart LM, van der Most R, Srouji JR, Türeci Ö, Gaynor RB, Şahin U, and Poran A

Subjects
Animals, Humans, Mice, Macaca fascicularis, Vaccines, Combined, Vaccinia virus genetics, Monkeypox virus genetics, Mpox (monkeypox) immunology, Mpox (monkeypox) prevention & control, Smallpox Vaccine
Abstract

In response to the 2022 outbreak of mpox driven by unprecedented human-to-human monkeypox virus (MPXV) transmission, we designed BNT166, aiming to create a highly immunogenic, safe, accessible, and scalable next-generation vaccine against MPXV and related orthopoxviruses. To address the multiple viral forms and increase the breadth of immune response, two candidate multivalent mRNA vaccines were evaluated pre-clinically: a quadrivalent vaccine (BNT166a; encoding the MPXV antigens A35, B6, M1, H3) and a trivalent vaccine (BNT166c; without H3). Both candidates induced robust T cell responses and IgG antibodies in mice, including neutralizing antibodies to both MPXV and vaccinia virus. In challenge studies, BNT166a and BNT166c provided complete protection from vaccinia, clade I, and clade IIb MPXV. Furthermore, immunization with BNT166a was 100% effective at preventing death and at suppressing lesions in a lethal clade I MPXV challenge in cynomolgus macaques. These findings support the clinical evaluation of BNT166, now underway (NCT05988203)., Competing Interests: Declaration of interests U.S. and O.T. are management board members and employees at BioNTech SE. R.B.G. serves on the Board of Directors for Alkermes PLC, Infinity Pharmaceuticals, and Zai Laboratory; serves on the Scientific Advisory Board for Leap Therapeutics; is a consultant for Third Rock Ventures; and is a stockholder and employee of BioNTech US. B.C. and S.K. are employees of Bioqual, Inc. S.S. is an employee of Southern Research. A.Z., C.L.D., N.D.S., M.M., Y.J.L., G.M.P., A.D., R.S.V., K.S., A.G., C.L., D.A.R., H.D., A.C.W., T.A.A., F.M., A.B.V., L.M.S., R.v.d.M., J.R.S., and A.P. are current/past employees of BioNTech SE/BioNTech US, are stockholders, and/or are inventors on patents and patent applications related to RNA vaccines., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Published
2024
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7. Strong immunogenicity & protection in mice with PlaCCine: A COVID-19 DNA vaccine formulated with a functional polymer.

Author

Sood S, Matar MM, Kim J, Kinsella M, Rayavara K, Signer O, Henderson J, Rogers J, Chawla B, Narvaez B, Van Ry A, Kar S, Arnold A, Rice JS, Smith AM, Su D, Sparks J, Le Goff C, Boyer JD, and Anwer K

Subjects
Mice, Animals, COVID-19 Vaccines, SARS-CoV-2, Mice, Transgenic, Antibodies, Neutralizing, DNA, Antibodies, Viral, Spike Glycoprotein, Coronavirus genetics, Immunogenicity, Vaccine, Vaccines, DNA, COVID-19 prevention & control
Abstract

DNA- based vaccines have demonstrated the potential as a safe and effective modality. PlaCCine, a DNA-based vaccine approach described subsequently relies on a synthetic DNA delivery system and is independent of virus or device. The synthetic functionalized polymer combined with DNA demonstrated stability over 12 months at 4C and for one month at 25C. Transfection efficiency compared to naked DNA increased by 5-15-fold in murine skeletal muscle. Studies of DNA vaccines expressing spike proteins from variants D614G (pVAC15), Delta (pVAC16), or a D614G + Delta combination (pVAC17) were conducted. Mice immunized intramuscular injection (IM) with pVAC15, pVAC16 or pVAC17 formulated with functionalized polymer and adjuvant resulted in induction of spike-specific humoral and cellular responses. Antibody responses were observed after one immunization. And endpoint IgG titers increased to greater than 1x 10 5 two weeks after the second injection. Neutralizing antibodies as determined by a pseudovirus competition assay were observed following vaccination with pVAC15, pVAC16 or pVAC17. Spike specific T cell immune responses were also observed following vaccination and flow cytometry analysis demonstrated the cellular immune responses included both CD4 and CD8 spike specific T cells. The immune responses in vaccinated mice were maintained for up to 14 months after vaccination. In an immunization and challenge study of K18 hACE2 transgenic mice pVAC15, pVAC16 and pVAC17 induced immune responses lead to decreased lung viral loads by greater than 90 % along with improved clinical score. These findings suggest that PlaCCine DNA vaccines are effective and stable and further development against emerging SARS-CoV-2 variants is warranted., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: [Subeena Sood, Majed M. Matar, Jessica Kim, Meredyth Kinsella, Kempaiah Rayavara, Olivia Signer, John Henderson, Joseph Rogers, Austin Arnold, Jennifer S. Rice, Alanna M. Smith, Daishui Sui, Jeff Sparks, Corinne Le Goff, Jean D. Boyer and Khursheed Anwer report other support from Imunon Corporation during the conduct of the study. No disclosures were reported by the other authors.]., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Published
2024
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8. Disinsert, retract and rotate technique of plaque brachytherapy.

Author

Lomi N, Chawla B, and Das D

Subjects
Humans, Iodine Radioisotopes, Brachytherapy methods, Melanoma radiotherapy, Melanoma pathology, Choroid Neoplasms radiotherapy, Choroid Neoplasms pathology, Uveal Neoplasms
Abstract

Background: Plaque brachytherapy is commonly used in the management of choroidal melanomas. The surgical steps usually involve creating a conjunctival peritomy, fixing the recti muscles, with or without disinserting them based on the location of the lesion, and placing the plaque. The inferior oblique muscle is attached close to the macula, and in cases of perimacular or peripapillary lesions, the muscle needs to be sacrificed., Purpose: The authors here demonstrate a novel technique of placing radioactive plaque without disinserting the inferior oblique muscle in cases of perimacular or peripapillary choroidal melanomas., Synopsis: The video demonstrates how the "disinsert, retract, and rotate technique" of brachytherapy plaque placement can be performed and what are the fundamentals behind this technique. The authors have performed this procedure multiple times and there has been no incidence of plaque tilt or migration., Highlights: In perimacular and peripapillary choroidal melanoma brachytherapy plaque placement, the inferior oblique muscle can be spared. The simple technique does not lead to any tilt or migration of the radioactive plaque., Video Link: https://youtu.be/YMIg3rYyp2o., (Copyright © 2024 Copyright: © 2024 Indian Journal of Ophthalmology.)

Published
2024
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9. Identification of novel genes by targeted exome sequencing in Retinoblastoma.

Author

Bisht S, Chawla B, Kumar A, Vijayan V, Kumar M, Sharma P, and Dada R

Subjects
Humans, Exome Sequencing, Mutation, Genes, Retinoblastoma genetics, DNA Mutational Analysis, Proteins genetics, ADP-Ribosylation Factors genetics, Tumor Suppressor Proteins genetics, SOX Transcription Factors genetics, Retinoblastoma pathology, Retinal Neoplasms pathology
Abstract

Background: Retinoblastoma (RB) is initiated by mutation in both alleles of RB1 gene. However, few cases may occur even in the absence of RB1 mutation suggesting the role of genes other than RB1 ., Methodology: The current study was planned to utilize targeted exome sequencing in Indian RB patients affected with unilateral non-familial RB. 75 unilateral RB patients below 5 years of age were enrolled. Genomic DNA was extracted from blood and tumor tissue. From peripheral blood DNA, all coding and exon/intron regions were amplified using PCR and direct sequencing. Cases which did not harbor pathogenic variants in peripheral blood DNA were further screened for mutations in their tumor tissue DNA using targeted exome sequencing. Three pathogenicity prediction tools (Mutation Taster, SIFT, and PolyPhen-2) were used to determine the pathogenicity of non-synonymous variations. An in-house bioinformatics pipeline was devised for the mutation screening by targeted exome sequencing. Protein modeling studies were also done to predict the effect of the mutations on the protein structure and function., Results: Using the mentioned approach, we found two novel variants (g.69673&#95;69674insT and g.48373314C>A) in RB1 gene in peripheral blood DNA. We also found novel variants in eight genes ( RB1 , ACAD11 , GPR151 , KCNA1 , OTOR , SOX30 , ARL11 , and MYCT1 ) that may be associated with RB pathogenesis., Conclusion: The present study expands our current knowledge regarding the genomic landscape of RB and also highlights the importance of NGS technologies to detect genes and novel variants that may play an important role in cancer initiation, progression, and prognosis.

Published
2022
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10. Dual roles for nuclear RNAi Argonautes in Caenorhabditis elegans dosage compensation.

Author

Davis MB, Jash E, Chawla B, Haines RA, Tushman LE, Troll R, and Csankovszki G

Subjects
Animals, Argonaute Proteins genetics, Argonaute Proteins metabolism, Caenorhabditis elegans genetics, Caenorhabditis elegans metabolism, Dosage Compensation, Genetic, Female, Humans, Male, RNA Interference, X Chromosome genetics, X Chromosome metabolism, Caenorhabditis elegans Proteins metabolism, Disorders of Sex Development genetics
Abstract

Dosage compensation involves chromosome-wide gene regulatory mechanisms which impact higher order chromatin structure and are crucial for organismal health. Using a genetic approach, we identified Argonaute genes which promote dosage compensation in Caenorhabditis elegans. Dosage compensation in C. elegans hermaphrodites is initiated by the silencing of xol-1 and subsequent activation of the dosage compensation complex which binds to both hermaphrodite X chromosomes and reduces transcriptional output by half. A hallmark phenotype of dosage compensation mutants is decondensation of the X chromosomes. We characterized this phenotype in Argonaute mutants using X chromosome paint probes and fluorescence microscopy. We found that while nuclear Argonaute mutants hrde-1 and nrde-3, as well as mutants for the piRNA Argonaute prg-1, exhibit derepression of xol-1 transcripts, they also affect X chromosome condensation in a xol-1-independent manner. We also characterized the physiological contribution of Argonaute genes to dosage compensation using genetic assays and found that hrde-1 and nrde-3 contribute to healthy dosage compensation both upstream and downstream of xol-1., (© The Author(s) 2022. Published by Oxford University Press on behalf of Genetics Society of America. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Published
2022
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