2021年7月27日火曜日

変異株に対するアデノウィルスワクチン(Sputnik V) の中和能力

//Background//---
 SARS-CoV-2 pandemic is no end even over 1.5 years after the first confirmation. The infection number in the world increases from early July 2021 again. SARS-CoV-2 repeats mutation and elevates infectivity significantly more than wild type including Alpha and Delta variants. On the other hand, the vaccination rate of at lease one dose is about 27.2% as of 24/July, 2021. Herd immunity requires 70-80% vaccination rate. Therefore, vaccine for over 2 times dose plus current dose is needed mainly for the Low-Middle income countries. There are more than 20 kinds of vaccine in the world. However, the formal physiological, epidemiological, medical data are not sufficient. Furthermore, demand for vaccine significantly surpasses supply. To end the pandemic and recover society, equal vaccine supply and vaccination as early as possible are important. To this end, we need to build production capacity in the world.  
 Sputnik V (which is an adenovirus viral vector vaccine for COVID-19 developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Russia) is one of the important vaccines for equal distribution. On 2 February 2021, an interim analysis from trial indicated 91.6% efficacy without unusual side effect(2).
 Satoshi Ikegame, Mohammed N. A. Siddiquey, Chuan-Tien Hung et al. analyze the neutralization ability of Sputnik V for B.1.1.7 and B.1.351 variants(1). I hope to share a part of the contents with the global important readers.
 
//Result(1)//---
*Vaccine recipients cohort (n=12) in Argentina, two dose regimen
Neutralization ability: Geometric mean titer
B.1.1.7 / Wild Type / B.1.351 / E484K:  
87.1 / 49.4 / 7.9 / 17.0
 
//Discussion//---
 Sputnik V is an adenovirus viral vaccine similar to ChAdOx1 nCoV-19 (Astrazeneca in U.K.) or Ad26.CoV2.S. (Janssen in Belgium). ChAdOx1 nCoV-19 vaccine has not confirmed the positive outcomes against mild-moderate case(3). However, Ad26.CoV2.S. has confirmed a vaccine efficacy of 57% against moderate-to-severe case, 89% against severe case(4). Epidemiological data (infection, mild, moderate, severe symptoms) of Sputnik V against current variants including Delta variant and the other variant especially with immune escape mutation like E484K is highly demanded.
 
//Contributions(1)//---
S.I., C.P., J.P.K., and B.H.L. conceived of and supervised the study. C.P., A.E.V., and A.E. supervised, collected, analyzed, and provided materials relevant to this study. S.I. developed the rcVSV-CoV-2 S reverse genetics system. S.I., M.N.A.S., C-T.H., G.H., S.K., and H.-P.C. were involved in the generation of S mutant viruses. S.I, L.B., S.K., M.N.A.S., C.S.S., and K.Y.O. conducted neutralization assays. S.I. and C.-T.H. developed the Sendai virus protein expressing system and purified RBD-Fc protein. S.I. and B.H.L. analyzed the data. S.I., B.H.L., and J.P.K. wrote the paper with input from C.P. and all co-authors.
 
//Ethics declarations(1)//---
Competing interests
B.L., C.S., and K.Y.O. are named inventors on a patent filed by the Icahn School of Medicine, which includes the 293T-ACE2-TMPRSS2 (F8-2) cells used for the virus neutralization assay. J.P.K. is a consultant for BioNTech (advisory panel on coronavirus variants). The remaining authors declare no competing interests.
 
//Peer review information(1)//---
 Nature Communications thanks Andreas Radbruch and the other anonymous reviewer(s) for their contribution to the peer review of this work. Peer reviewer reports are available.
 
(Reference)
(1)
Satoshi Ikegame, Mohammed N. A. Siddiquey, Chuan-Tien Hung, Griffin Haas, Luca Brambilla, Kasopefoluwa Y. Oguntuyo, Shreyas Kowdle, Hsin-Ping Chiu, Christian S. Stevens, Ariel Esteban Vilardo, Alexis Edelstein, Claudia Perandones, Jeremy P. Kamil & Benhur Lee
Neutralizing activity of Sputnik V vaccine sera against SARS-CoV-2 variants
Nature Communications volume 12, Article number: 4598 (2021)
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Author information
Author notes
These authors contributed equally: Mohammed N. A. Siddiquey, Chuan-Tien Hung.
These authors jointly supervised this work: Claudia Perandones, Jeremy P. Kamil, Benhur Lee.
Affiliations
Department of Microbiology at the Icahn School of Medicine at Mount Sinai, New York, NY, USA
Satoshi Ikegame, Chuan-Tien Hung, Griffin Haas, Luca Brambilla, Kasopefoluwa Y. Oguntuyo, Shreyas Kowdle, Hsin-Ping Chiu, Christian S. Stevens & Benhur Lee
Department of Microbiology and Immunology, Louisiana State University Health Shreveport, Shreveport, LA, USA
Mohammed N. A. Siddiquey & Jeremy P. Kamil
National Administration of Laboratories and Health Institutes of Argentina (ANLIS) Dr. Carlos G. Malbrán, Buenos Aires, Argentina
Ariel Esteban Vilardo, Alexis Edelstein & Claudia Perandones
(2)
LDenis Y Logunov, DSc  Inna V Dolzhikova, PhD *Dmitry V Shcheblyakov, PhD Amir I Tukhvatulin, PhD Olga V Zubkova, PhDAlina S Dzharullaeva, MSc Anna V Kovyrshina, MSc Nadezhda L Lubenets, MSc Daria M Grousova, MSc Alina S Erokhova, MSc Andrei G Botikov, MScFatima M Izhaeva, MSc Olga Popova, MSc Tatiana A Ozharovskaya, MSc Ilias B Esmagambetov, PhD Irina A Favorskaya, PhD Denis I Zrelkin, MSc Daria V Voronina, MSc Dmitry N Shcherbinin, PhD Alexander S Semikhin, PhD Yana V Simakova, MSc Elizaveta A Tokarskaya, PhD Daria A Egorova, PhD Maksim M Shmarov, DSc Natalia A Nikitenko, PhD Vladimir A Gushchin, PhD Elena A Smolyarchuk, PhD Sergey K Zyryanov, DSc Sergei V Borisevich, DSc Prof Boris S Naroditsky, DSc Prof Alexander L Gintsburg, DSc
Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia.
The Lancet. 397 (10275): 671–681.
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Health of the Russian Federation (Sechenov University), Moscow, Russia (E A Smolyarchuk PhD, Prof A L Gintsburg); Peoples’Friendship University of Russia (RUDN University), Moscow, Russia (S K Zyryanov DSc); 48 Central Research Institute of the Ministry of Defence of the Russian Federation, Moscow, Russia (S V Borisevich DSc)
(3)
Shabir A. Madhi, Ph.D., Vicky Baillie, Ph.D., Clare L. Cutland, Ph.D., Merryn Voysey, D.Phil., Anthonet L. Koen, M.B., B.Ch., Lee Fairlie, F.C.Paeds., Sherman D. Padayachee, M.B., Ch.B., Keertan Dheda, Ph.D., Shaun L. Barnabas, Ph.D., Qasim E. Bhorat, M.Sc., Carmen Briner, M.B., B.Ch., Gaurav Kwatra, Ph.D., Khatija Ahmed, F.C.Path. (Micro), Parvinder Aley, D.Phil., Sutika Bhikha, M.B., B.Ch., Jinal N. Bhiman, Ph.D., As’ad E. Bhorat, F.R.A.C.G.P., Jeanine du Plessis, B.Sc., Aliasgar Esmail, M.D., Marisa Groenewald, M.B., B.Ch., Elizea Horne, M.B., B.Ch., Shi-Hsia Hwa, M.Sc., Aylin Jose, M.B., B.Ch., Teresa Lambe, Ph.D., Matt Laubscher, M.Sc., Mookho Malahleha, M.B., Ch.B., Masebole Masenya, M.B., Ch.B., Mduduzi Masilela, M.B., Ch.B., Shakeel McKenzie, B.Sc., Kgaogelo Molapo, Nat.Dip.O.H.S., Andrew Moultrie, B.Sc., Suzette Oelofse, M.B., Ch.B., Faeezah Patel, M.B., B.Ch., Sureshnee Pillay, B.Sc., Sarah Rhead, M.B., Ch.B., Hylton Rodel, B.Sc., Lindie Rossouw, M.B., B.Ch., Carol Taoushanis, B.Pharm., Houriiyah Tegally, M.Sc., Asha Thombrayil, M.B., B.Ch., Samuel van Eck, R.N., Constantinos K. Wibmer, Ph.D., Nicholas M. Durham, Ph.D., Elizabeth J. Kelly, Ph.D., Tonya L. Villafana, Ph.D., Sarah Gilbert, Ph.D., Andrew J. Pollard, F.Med.Sci., Tulio de Oliveira, Ph.D., Penny L. Moore, Ph.D., Alex Sigal, Ph.D., and Alane Izu, Ph.D. for the NGS-SA Group, and the Wits-VIDA COVID Group*
Efficacy of the ChAdOx1 nCoV-19 Covid-19 Vaccine against the B.1.351 Variant
The New England Journal of Medicine 2021; 384:1885-1898
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Author Affiliations
From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town (K.D., A.E., S.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch (S.L.B., M.G., L.R.), Cape Town, Soweto Clinical Trials Centre, Soweto (Q.E.B., A.E.B.), and the Africa Health Research Institute (S.-H.H., H.R., A.S.) and the KwaZulu-Natal Research and Innovation Sequencing Platform (KRISP), University of KwaZulu-Natal (S.P., H.T., T.O., A.S.), Durban — all in South Africa; the Oxford Vaccine Group, Department of Paediatrics (M.V., P.A., S.R., A.J.P.), and Jenner Institute, Nuffield Department of Medicine (T.L., S.G.), University of Oxford, Oxford, the Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London (K.D., A.E.), Division of Infection and Immunity, University College London, London (K.D.), and AstraZeneca Biopharmaceuticals, Cambridge (N.M.D., E.J.K., T.L.V.) — all in the United Kingdom; and Max Planck Institute for Infection Biology, Berlin (S.-H.H., H.R.).
(4)
Johnson & Johnson. Johnson & Johnson COVID-19 vaccine authorized by U.S. FDA for emergency use — first single-shot vaccine in fight against global pandemic. February 27, 2021 (https://www.jnj.com/johnson-johnson-announces-single-shot-janssen-covid-19-vaccine-candidate-met-primary-endpoints-in-interim-analysis-of-its-phase-3-ensemble-trial. opens in new tab).

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