Clinical trial NCT04934111 - References

COVID-19 — Safety and Immunogenicity of LNP-nCOV saRNA-02 Vaccine Against SARS-CoV-2, the Causative Agent of COVID-19

Citation(s)

•   Alberer M, Gnad-Vogt U, Hong HS, Mehr KT, Backert L, Finak G, Gottardo R, Bica MA, Garofano A, Koch SD, Fotin-Mleczek M, Hoerr I, Clemens R, von Sonnenburg F
  Safety and immunogenicity of a mRNA rabies vaccine in healthy adults: an open-label, non-randomised, prospective, first-in-human phase 1 clinical trial. Lancet. 2017 Sep 23;390(10101):1511-1520. doi: 10.1016/S0140-6736(17)31665-3. Epub 2017 Jul 25.
•   Batool M, Shah M, Patra MC, Yesudhas D, Choi S
  Structural insights into the Middle East respiratory syndrome coronavirus 4a protein and its dsRNA binding mechanism. Sci Rep. 2017 Sep 12;7(1):11362. doi: 10.1038/s41598-017-11736-6.
•   Bernstein DI, Reap EA, Katen K, Watson A, Smith K, Norberg P, Olmsted RA, Hoeper A, Morris J, Negri S, Maughan MF, Chulay JD
  Randomized, double-blind, Phase 1 trial of an alphavirus replicon vaccine for cytomegalovirus in CMV seronegative adult volunteers. Vaccine. 2009 Dec 11;28(2):484-93. doi: 10.1016/j.vaccine.2009.09.135. Epub 2009 Oct 24.
•   Bolles M, Deming D, Long K, Agnihothram S, Whitmore A, Ferris M, Funkhouser W, Gralinski L, Totura A, Heise M, Baric RS
  A double-inactivated severe acute respiratory syndrome coronavirus vaccine provides incomplete protection in mice and induces increased eosinophilic proinflammatory pulmonary response upon challenge. J Virol. 2011 Dec;85(23):12201-15. doi: 10.1128/JVI.06048-11. Epub 2011 Sep 21.
•   Brito LA, Kommareddy S, Maione D, Uematsu Y, Giovani C, Berlanda Scorza F, Otten GR, Yu D, Mandl CW, Mason PW, Dormitzer PR, Ulmer JB, Geall AJ
  Self-amplifying mRNA vaccines. Adv Genet. 2015;89:179-233. doi: 10.1016/bs.adgen.2014.10.005. Epub 2014 Dec 4.
•   Cashman KA, Broderick KE, Wilkinson ER, Shaia CI, Bell TM, Shurtleff AC, Spik KW, Badger CV, Guttieri MC, Sardesai NY, Schmaljohn CS
  Enhanced Efficacy of a Codon-Optimized DNA Vaccine Encoding the Glycoprotein Precursor Gene of Lassa Virus in a Guinea Pig Disease Model When Delivered by Dermal Electroporation. Vaccines (Basel). 2013 Jul 18;1(3):262-77. doi: 10.3390/vaccines1030262.
•   Castilow EM, Olson MR, Varga SM
  Understanding respiratory syncytial virus (RSV) vaccine-enhanced disease. Immunol Res. 2007;39(1-3):225-39. Review.
•   Collins PL, Graham BS
  Viral and host factors in human respiratory syncytial virus pathogenesis. J Virol. 2008 Mar;82(5):2040-55. Epub 2007 Oct 10. Review.
•   Crank MC, Ruckwardt TJ, Chen M, Morabito KM, Phung E, Costner PJ, Holman LA, Hickman SP, Berkowitz NM, Gordon IJ, Yamshchikov GV, Gaudinski MR, Kumar A, Chang LA, Moin SM, Hill JP, DiPiazza AT, Schwartz RM, Kueltzo L, Cooper JW, Chen P, Stein JA, Carlton K, Gall JG, Nason MC, Kwong PD, Chen GL, Mascola JR, McLellan JS, Ledgerwood JE, Graham BS; VRC 317 Study Team
  A proof of concept for structure-based vaccine design targeting RSV in humans. Science. 2019 Aug 2;365(6452):505-509. doi: 10.1126/science.aav9033.
•   Deming D, Sheahan T, Heise M, Yount B, Davis N, Sims A, Suthar M, Harkema J, Whitmore A, Pickles R, West A, Donaldson E, Curtis K, Johnston R, Baric R
  Vaccine efficacy in senescent mice challenged with recombinant SARS-CoV bearing epidemic and zoonotic spike variants. PLoS Med. 2006 Dec;3(12):e525. Erratum in: PLoS Med. 2007 Feb;4(2):e80.
•   Démoulins T, Milona P, Englezou PC, Ebensen T, Schulze K, Suter R, Pichon C, Midoux P, Guzmán CA, Ruggli N, McCullough KC
  Polyethylenimine-based polyplex delivery of self-replicating RNA vaccines. Nanomedicine. 2016 Apr;12(3):711-722. doi: 10.1016/j.nano.2015.11.001. Epub 2015 Dec 1.
•   Erwin-Cohen RA, Porter AI, Pittman PR, Rossi CA, DaSilva L
  Human transcriptome response to immunization with live-attenuated Venezuelan equine encephalitis virus vaccine (TC-83): Analysis of whole blood. Hum Vaccin Immunother. 2017 Jan 2;13(1):169-179. doi: 10.1080/21645515.2016.1227900. Epub 2016 Nov 21.
•   Feldman RA, Fuhr R, Smolenov I, Mick Ribeiro A, Panther L, Watson M, Senn JJ, Smith M, Almarsson ?, Pujar HS, Laska ME, Thompson J, Zaks T, Ciaramella G
  mRNA vaccines against H10N8 and H7N9 influenza viruses of pandemic potential are immunogenic and well tolerated in healthy adults in phase 1 randomized clinical trials. Vaccine. 2019 May 31;37(25):3326-3334. doi: 10.1016/j.vaccine.2019.04.074. Epub 2019 May 10.
•   Geall AJ, Verma A, Otten GR, Shaw CA, Hekele A, Banerjee K, Cu Y, Beard CW, Brito LA, Krucker T, O'Hagan DT, Singh M, Mason PW, Valiante NM, Dormitzer PR, Barnett SW, Rappuoli R, Ulmer JB, Mandl CW
  Nonviral delivery of self-amplifying RNA vaccines. Proc Natl Acad Sci U S A. 2012 Sep 4;109(36):14604-9. doi: 10.1073/pnas.1209367109. Epub 2012 Aug 20.
•   Grant-Klein RJ, Altamura LA, Badger CV, Bounds CE, Van Deusen NM, Kwilas SA, Vu HA, Warfield KL, Hooper JW, Hannaman D, Dupuy LC, Schmaljohn CS
  Codon-optimized filovirus DNA vaccines delivered by intramuscular electroporation protect cynomolgus macaques from lethal Ebola and Marburg virus challenges. Hum Vaccin Immunother. 2015;11(8):1991-2004. doi: 10.1080/21645515.2015.1039757.
•   Grant-Klein RJ, Van Deusen NM, Badger CV, Hannaman D, Dupuy LC, Schmaljohn CS
  A multiagent filovirus DNA vaccine delivered by intramuscular electroporation completely protects mice from ebola and Marburg virus challenge. Hum Vaccin Immunother. 2012 Nov 1;8(11):1703-6. doi: 10.4161/hv.21873. Epub 2012 Aug 24.
•   Hadinegoro SR, Arredondo-García JL, Capeding MR, Deseda C, Chotpitayasunondh T, Dietze R, Muhammad Ismail HI, Reynales H, Limkittikul K, Rivera-Medina DM, Tran HN, Bouckenooghe A, Chansinghakul D, Cortés M, Fanouillere K, Forrat R, Frago C, Gailhardou S, Jackson N, Noriega F, Plennevaux E, Wartel TA, Zambrano B, Saville M; CYD-TDV Dengue Vaccine Working Group
  Efficacy and Long-Term Safety of a Dengue Vaccine in Regions of Endemic Disease. N Engl J Med. 2015 Sep 24;373(13):1195-206. doi: 10.1056/NEJMoa1506223. Epub 2015 Jul 27.
•   Herbert AS, Kuehne AI, Barth JF, Ortiz RA, Nichols DK, Zak SE, Stonier SW, Muhammad MA, Bakken RR, Prugar LI, Olinger GG, Groebner JL, Lee JS, Pratt WD, Custer M, Kamrud KI, Smith JF, Hart MK, Dye JM
  Venezuelan equine encephalitis virus replicon particle vaccine protects nonhuman primates from intramuscular and aerosol challenge with ebolavirus. J Virol. 2013 May;87(9):4952-64. doi: 10.1128/JVI.03361-12. Epub 2013 Feb 13.
•   Hoy SM
  Patisiran: First Global Approval. Drugs. 2018 Oct;78(15):1625-1631. doi: 10.1007/s40265-018-0983-6. Review.
•   Jaume M, Yip MS, Cheung CY, Leung HL, Li PH, Kien F, Dutry I, Callendret B, Escriou N, Altmeyer R, Nal B, Daëron M, Bruzzone R, Peiris JS
  Anti-severe acute respiratory syndrome coronavirus spike antibodies trigger infection of human immune cells via a pH- and cysteine protease-independent Fc?R pathway. J Virol. 2011 Oct;85(20):10582-97. doi: 10.1128/JVI.00671-11. Epub 2011 Jul 20.
•   Kam YW, Kien F, Roberts A, Cheung YC, Lamirande EW, Vogel L, Chu SL, Tse J, Guarner J, Zaki SR, Subbarao K, Peiris M, Nal B, Altmeyer R
  Antibodies against trimeric S glycoprotein protect hamsters against SARS-CoV challenge despite their capacity to mediate FcgammaRII-dependent entry into B cells in vitro. Vaccine. 2007 Jan 8;25(4):729-40. Epub 2006 Aug 22.
•   Kentner AC, Miguelez M, James JS, Bielajew C
  Behavioral and physiological effects of a single injection of rat interferon-alpha on male Sprague-Dawley rats: a long-term evaluation. Brain Res. 2006 Jun 20;1095(1):96-106. Epub 2006 May 18.
•   Kis Z, Shattock R, Shah N, Kontoravdi C
  Emerging Technologies for Low-Cost, Rapid Vaccine Manufacture. Biotechnol J. 2019 Jan;14(1):e1800376. doi: 10.1002/biot.201800376. Epub 2018 Dec 10. Review. Erratum in: Biotechnol J. 2019 Jul;14(7):1-2.
•   Li L, Petrovsky N
  Molecular mechanisms for enhanced DNA vaccine immunogenicity. Expert Rev Vaccines. 2016;15(3):313-29. doi: 10.1586/14760584.2016.1124762. Epub 2015 Dec 28. Review.
•   Li W, Ye L, Carrion R Jr, Mohan GS, Nunneley J, Staples H, Ticer A, Patterson JL, Compans RW, Yang C
  Characterization of Immune Responses Induced by Ebola Virus Glycoprotein (GP) and Truncated GP Isoform DNA Vaccines and Protection Against Lethal Ebola Virus Challenge in Mice. J Infect Dis. 2015 Oct 1;212 Suppl 2:S398-403. doi: 10.1093/infdis/jiv186. Epub 2015 Apr 14.
•   Liu L, Wei Q, Lin Q, Fang J, Wang H, Kwok H, Tang H, Nishiura K, Peng J, Tan Z, Wu T, Cheung KW, Chan KH, Alvarez X, Qin C, Lackner A, Perlman S, Yuen KY, Chen Z
  Anti-spike IgG causes severe acute lung injury by skewing macrophage responses during acute SARS-CoV infection. JCI Insight. 2019 Feb 21;4(4). pii: 123158. doi: 10.1172/jci.insight.123158. eCollection 2019 Feb 21.
•   Ljungberg K, Liljeström P
  Self-replicating alphavirus RNA vaccines. Expert Rev Vaccines. 2015 Feb;14(2):177-94. doi: 10.1586/14760584.2015.965690. Epub 2014 Oct 1. Review.
•   Lokugamage KG, Yoshikawa-Iwata N, Ito N, Watts DM, Wyde PR, Wang N, Newman P, Kent Tseng CT, Peters CJ, Makino S
  Chimeric coronavirus-like particles carrying severe acute respiratory syndrome coronavirus (SCoV) S protein protect mice against challenge with SCoV. Vaccine. 2008 Feb 6;26(6):797-808. doi: 10.1016/j.vaccine.2007.11.092. Epub 2007 Dec 26.
•   Lui PY, Wong LR, Ho TH, Au SWN, Chan CP, Kok KH, Jin DY
  PACT Facilitates RNA-Induced Activation of MDA5 by Promoting MDA5 Oligomerization. J Immunol. 2017 Sep 1;199(5):1846-1855. doi: 10.4049/jimmunol.1601493. Epub 2017 Jul 31.
•   Luo F, Liao FL, Wang H, Tang HB, Yang ZQ, Hou W
  Evaluation of Antibody-Dependent Enhancement of SARS-CoV Infection in Rhesus Macaques Immunized with an Inactivated SARS-CoV Vaccine. Virol Sin. 2018 Apr;33(2):201-204. doi: 10.1007/s12250-018-0009-2. Epub 2018 Mar 14.
•   Mascola JR, Mathieson BJ, Zack PM, Walker MC, Halstead SB, Burke DS
  Summary report: workshop on the potential risks of antibody-dependent enhancement in human HIV vaccine trials. AIDS Res Hum Retroviruses. 1993 Dec;9(12):1175-84.
•   McKay PF, Hu K, Blakney AK, Samnuan K, Brown JC, Penn R, Zhou J, Bouton CR, Rogers P, Polra K, Lin PJC, Barbosa C, Tam YK, Barclay WS, Shattock RJ
  Self-amplifying RNA SARS-CoV-2 lipid nanoparticle vaccine candidate induces high neutralizing antibody titers in mice. Nat Commun. 2020 Jul 9;11(1):3523. doi: 10.1038/s41467-020-17409-9.
•   McLellan JS, Chen M, Joyce MG, Sastry M, Stewart-Jones GB, Yang Y, Zhang B, Chen L, Srivatsan S, Zheng A, Zhou T, Graepel KW, Kumar A, Moin S, Boyington JC, Chuang GY, Soto C, Baxa U, Bakker AQ, Spits H, Beaumont T, Zheng Z, Xia N, Ko SY, Todd JP, Rao S, Graham BS, Kwong PD
  Structure-based design of a fusion glycoprotein vaccine for respiratory syncytial virus. Science. 2013 Nov 1;342(6158):592-8. doi: 10.1126/science.1243283. Erratum in: Science. 2013 Nov 22;342(6161):931.
•   NCT04283461
  Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) to Prevent SARS-CoV-2 Infection
•   Pepini T, Pulichino AM, Carsillo T, Carlson AL, Sari-Sarraf F, Ramsauer K, Debasitis JC, Maruggi G, Otten GR, Geall AJ, Yu D, Ulmer JB, Iavarone C
  Induction of an IFN-Mediated Antiviral Response by a Self-Amplifying RNA Vaccine: Implications for Vaccine Design. J Immunol. 2017 May 15;198(10):4012-4024. doi: 10.4049/jimmunol.1601877. Epub 2017 Apr 17.
•   Rabouw HH, Langereis MA, Knaap RC, Dalebout TJ, Canton J, Sola I, Enjuanes L, Bredenbeek PJ, Kikkert M, de Groot RJ, van Kuppeveld FJ
  Middle East Respiratory Coronavirus Accessory Protein 4a Inhibits PKR-Mediated Antiviral Stress Responses. PLoS Pathog. 2016 Oct 26;12(10):e1005982. doi: 10.1371/journal.ppat.1005982. eCollection 2016 Oct.
•   Sahin U, Karikó K, Türeci Ö
  mRNA-based therapeutics--developing a new class of drugs. Nat Rev Drug Discov. 2014 Oct;13(10):759-80. doi: 10.1038/nrd4278. Epub 2014 Sep 19. Review.
•   Shedlock DJ, Aviles J, Talbott KT, Wong G, Wu SJ, Villarreal DO, Myles DJ, Croyle MA, Yan J, Kobinger GP, Weiner DB
  Induction of broad cytotoxic T cells by protective DNA vaccination against Marburg and Ebola. Mol Ther. 2013 Jul;21(7):1432-44. doi: 10.1038/mt.2013.61. Epub 2013 May 14.
•   Siu KL, Yeung ML, Kok KH, Yuen KS, Kew C, Lui PY, Chan CP, Tse H, Woo PC, Yuen KY, Jin DY
  Middle east respiratory syndrome coronavirus 4a protein is a double-stranded RNA-binding protein that suppresses PACT-induced activation of RIG-I and MDA5 in the innate antiviral response. J Virol. 2014 May;88(9):4866-76. doi: 10.1128/JVI.03649-13. Epub 2014 Feb 12.
•   Slovin SF, Kehoe M, Durso R, Fernandez C, Olson W, Gao JP, Israel R, Scher HI, Morris S
  A phase I dose escalation trial of vaccine replicon particles (VRP) expressing prostate-specific membrane antigen (PSMA) in subjects with prostate cancer. Vaccine. 2013 Jan 30;31(6):943-9. doi: 10.1016/j.vaccine.2012.11.096. Epub 2012 Dec 13.
•   Takada A, Kawaoka Y
  Antibody-dependent enhancement of viral infection: molecular mechanisms and in vivo implications. Rev Med Virol. 2003 Nov-Dec;13(6):387-98. Review.
•   Tseng CT, Sbrana E, Iwata-Yoshikawa N, Newman PC, Garron T, Atmar RL, Peters CJ, Couch RB
  Immunization with SARS coronavirus vaccines leads to pulmonary immunopathology on challenge with the SARS virus. PLoS One. 2012;7(4):e35421. doi: 10.1371/journal.pone.0035421. Epub 2012 Apr 20. Erratum in: PLoS One. 2012;7(8). doi:10.1371/annotation/2965cfae-b77d-4014-8b7b-236e01a35492.
•   Ulmer JB, Mansoura MK, Geall AJ
  Vaccines 'on demand': science fiction or a future reality. Expert Opin Drug Discov. 2015 Feb;10(2):101-6. doi: 10.1517/17460441.2015.996128. Epub 2015 Jan 13.
•   Vogel AB, Lambert L, Kinnear E, Busse D, Erbar S, Reuter KC, Wicke L, Perkovic M, Beissert T, Haas H, Reece ST, Sahin U, Tregoning JS
  Self-Amplifying RNA Vaccines Give Equivalent Protection against Influenza to mRNA Vaccines but at Much Lower Doses. Mol Ther. 2018 Feb 7;26(2):446-455. doi: 10.1016/j.ymthe.2017.11.017. Epub 2017 Dec 5.
•   Wan Y, Shang J, Sun S, Tai W, Chen J, Geng Q, He L, Chen Y, Wu J, Shi Z, Zhou Y, Du L, Li F
  Molecular Mechanism for Antibody-Dependent Enhancement of Coronavirus Entry. J Virol. 2020 Feb 14;94(5). pii: e02015-19. doi: 10.1128/JVI.02015-19. Print 2020 Feb 14.
•   Wang Q, Zhang L, Kuwahara K, Li L, Liu Z, Li T, Zhu H, Liu J, Xu Y, Xie J, Morioka H, Sakaguchi N, Qin C, Liu G
  Immunodominant SARS Coronavirus Epitopes in Humans Elicited both Enhancing and Neutralizing Effects on Infection in Non-human Primates. ACS Infect Dis. 2016 May 13;2(5):361-76. doi: 10.1021/acsinfecdis.6b00006. Epub 2016 Apr 11. Erratum in: ACS Infect Dis. 2020 May 8;6(5):1284-1285.
•   Wang SF, Tseng SP, Yen CH, Yang JY, Tsao CH, Shen CW, Chen KH, Liu FT, Liu WT, Chen YM, Huang JC
  Antibody-dependent SARS coronavirus infection is mediated by antibodies against spike proteins. Biochem Biophys Res Commun. 2014 Aug 22;451(2):208-14. doi: 10.1016/j.bbrc.2014.07.090. Epub 2014 Jul 26.
•   Wrapp D, Wang N, Corbett KS, Goldsmith JA, Hsieh CL, Abiona O, Graham BS, McLellan JS
  Cryo-EM structure of the 2019-nCoV spike in the prefusion conformation. Science. 2020 Mar 13;367(6483):1260-1263. doi: 10.1126/science.abb2507. Epub 2020 Feb 19.
•   Yang ZY, Werner HC, Kong WP, Leung K, Traggiai E, Lanzavecchia A, Nabel GJ
  Evasion of antibody neutralization in emerging severe acute respiratory syndrome coronaviruses. Proc Natl Acad Sci U S A. 2005 Jan 18;102(3):797-801. Epub 2005 Jan 10.
•   Yasui F, Kai C, Kitabatake M, Inoue S, Yoneda M, Yokochi S, Kase R, Sekiguchi S, Morita K, Hishima T, Suzuki H, Karamatsu K, Yasutomi Y, Shida H, Kidokoro M, Mizuno K, Matsushima K, Kohara M
  Prior immunization with severe acute respiratory syndrome (SARS)-associated coronavirus (SARS-CoV) nucleocapsid protein causes severe pneumonia in mice infected with SARS-CoV. J Immunol. 2008 Nov 1;181(9):6337-48.
•   Yip MS, Leung HL, Li PH, Cheung CY, Dutry I, Li D, Daëron M, Bruzzone R, Peiris JS, Jaume M
  Antibody-dependent enhancement of SARS coronavirus infection and its role in the pathogenesis of SARS. Hong Kong Med J. 2016 Jun;22(3 Suppl 4):25-31.

A Clinical Trial to Assess the Safety and Immunogenicity of LNP-nCOV saRNA-02, a Self-amplifying Ribonucleic Acid (saRNA) Vaccine, in SARS-CoV-2 Seronegative and Seropositive Uganda Population

Details for clinical trial NCT04934111