Clinical trial NCT03055585 - References

Dengue — Applying Wolbachia to Eliminate Dengue

Citation(s)

•   Amuzu HE, Simmons CP, McGraw EA
  Effect of repeat human blood feeding on Wolbachia density and dengue virus infection in Aedes aegypti. Parasit Vectors. 2015 Apr 24;8:246. doi: 10.1186/s13071-015-0853-y.
•   Andersson N, Nava-Aguilera E, Arosteguí J, Morales-Perez A, Suazo-Laguna H, Legorreta-Soberanis J, Hernandez-Alvarez C, Fernandez-Salas I, Paredes-Solís S, Balmaseda A, Cortés-Guzmán AJ, Serrano de Los Santos R, Coloma J, Ledogar RJ, Harris E
  Evidence based community mobilization for dengue prevention in Nicaragua and Mexico (Camino Verde, the Green Way): cluster randomized controlled trial. BMJ. 2015 Jul 8;351:h3267. doi: 10.1136/bmj.h3267.
•   Bhatt S, Gething PW, Brady OJ, Messina JP, Farlow AW, Moyes CL, Drake JM, Brownstein JS, Hoen AG, Sankoh O, Myers MF, George DB, Jaenisch T, Wint GR, Simmons CP, Scott TW, Farrar JJ, Hay SI
  The global distribution and burden of dengue. Nature. 2013 Apr 25;496(7446):504-7. doi: 10.1038/nature12060. Epub 2013 Apr 7.
•   Bowman LR, Donegan S, McCall PJ
  Is Dengue Vector Control Deficient in Effectiveness or Evidence?: Systematic Review and Meta-analysis. PLoS Negl Trop Dis. 2016 Mar 17;10(3):e0004551. doi: 10.1371/journal.pntd.0004551. eCollection 2016 Mar. Review.
•   Bowman LR, Runge-Ranzinger S, McCall PJ
  Assessing the relationship between vector indices and dengue transmission: a systematic review of the evidence. PLoS Negl Trop Dis. 2014 May 8;8(5):e2848. doi: 10.1371/journal.pntd.0002848. eCollection 2014 May. Review.
•   BPS - Statistics Indonesia
  Badan Pusat Statistik. (2016). Available at: www.bps.go.id
•   Brady OJ, Gething PW, Bhatt S, Messina JP, Brownstein JS, Hoen AG, Moyes CL, Farlow AW, Scott TW, Hay SI
  Refining the global spatial limits of dengue virus transmission by evidence-based consensus. PLoS Negl Trop Dis. 2012;6(8):e1760. doi: 10.1371/journal.pntd.0001760. Epub 2012 Aug 7.
•   Capeding MR, Tran NH, Hadinegoro SR, Ismail HI, Chotpitayasunondh T, Chua MN, Luong CQ, Rusmil K, Wirawan DN, Nallusamy R, Pitisuttithum P, Thisyakorn U, Yoon IK, van der Vliet D, Langevin E, Laot T, Hutagalung Y, Frago C, Boaz M, Wartel TA, Tornieporth NG, Saville M, Bouckenooghe A; CYD14 Study Group
  Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial. Lancet. 2014 Oct 11;384(9951):1358-65. doi: 10.1016/S0140-6736(14)61060-6. Epub 2014 Jul 10.
•   De Serres G, Skowronski DM, Wu XW, Ambrose CS
  The test-negative design: validity, accuracy and precision of vaccine efficacy estimates compared to the gold standard of randomised placebo-controlled clinical trials. Euro Surveill. 2013 Sep 12;18(37). pii: 20585.
•   Degener CM, Eiras AE, Azara TM, Roque RA, Rösner S, Codeço CT, Nobre AA, Rocha ES, Kroon EG, Ohly JJ, Geier M
  Evaluation of the effectiveness of mass trapping with BG-sentinel traps for dengue vector control: a cluster randomized controlled trial in Manaus, Brazil. J Med Entomol. 2014 Mar;51(2):408-20.
•   Dengue Vaccine Initiative
  Dengue vaccine candidates in clinical development. (2016). Available at: http://www.denguevaccines.org/vaccine-development. (Accessed: 13th June 2016)
•   Dutra HL, Rocha MN, Dias FB, Mansur SB, Caragata EP, Moreira LA
  Wolbachia Blocks Currently Circulating Zika Virus Isolates in Brazilian Aedes aegypti Mosquitoes. Cell Host Microbe. 2016 Jun 8;19(6):771-4. doi: 10.1016/j.chom.2016.04.021. Epub 2016 May 4.
•   Endy TP, Yoon IK, Mammen MP
  Prospective cohort studies of dengue viral transmission and severity of disease. Curr Top Microbiol Immunol. 2010;338:1-13. doi: 10.1007/978-3-642-02215-9_1. Review.
•   Erlanger TE, Keiser J, Utzinger J
  Effect of dengue vector control interventions on entomological parameters in developing countries: a systematic review and meta-analysis. Med Vet Entomol. 2008 Sep;22(3):203-21. doi: 10.1111/j.1365-2915.2008.00740.x. Review.
•   Esu E, Lenhart A, Smith L, Horstick O
  Effectiveness of peridomestic space spraying with insecticide on dengue transmission; systematic review. Trop Med Int Health. 2010 May;15(5):619-31. doi: 10.1111/j.1365-3156.2010.02489.x. Epub 2010 Mar 8. Review.
•   Ferguson NM, Kien DT, Clapham H, Aguas R, Trung VT, Chau TN, Popovici J, Ryan PA, O'Neill SL, McGraw EA, Long VT, Dui le T, Nguyen HL, Chau NV, Wills B, Simmons CP
  Modeling the impact on virus transmission of Wolbachia-mediated blocking of dengue virus infection of Aedes aegypti. Sci Transl Med. 2015 Mar 18;7(279):279ra37. doi: 10.1126/scitranslmed.3010370.
•   Frentiu FD, Zakir T, Walker T, Popovici J, Pyke AT, van den Hurk A, McGraw EA, O'Neill SL
  Limited dengue virus replication in field-collected Aedes aegypti mosquitoes infected with Wolbachia. PLoS Negl Trop Dis. 2014 Feb 20;8(2):e2688. doi: 10.1371/journal.pntd.0002688. eCollection 2014 Feb.
•   Graham RR, Juffrie M, Tan R, Hayes CG, Laksono I, Ma'roef C, Erlin, Sutaryo, Porter KR, Halstead SB
  A prospective seroepidemiologic study on dengue in children four to nine years of age in Yogyakarta, Indonesia I. studies in 1995-1996. Am J Trop Med Hyg. 1999 Sep;61(3):412-9.
•   Greenland S, Thomas DC
  On the need for the rare disease assumption in case-control studies. Am J Epidemiol. 1982 Sep;116(3):547-53. Erratum in: Am J Epidemiol 1990 Jun;131(6):1102.
•   Guy B, Lang J, Saville M, Jackson N
  Vaccination Against Dengue: Challenges and Current Developments. Annu Rev Med. 2016;67:387-404. doi: 10.1146/annurev-med-091014-090848. Epub 2015 Oct 23. Review.
•   Haber M, An Q, Foppa IM, Shay DK, Ferdinands JM, Orenstein WA
  A probability model for evaluating the bias and precision of influenza vaccine effectiveness estimates from case-control studies. Epidemiol Infect. 2015 May;143(7):1417-26. doi: 10.1017/S0950268814002179. Epub 2014 Aug 22.
•   Haddow AD, Schuh AJ, Yasuda CY, Kasper MR, Heang V, Huy R, Guzman H, Tesh RB, Weaver SC
  Genetic characterization of Zika virus strains: geographic expansion of the Asian lineage. PLoS Negl Trop Dis. 2012;6(2):e1477. doi: 10.1371/journal.pntd.0001477. Epub 2012 Feb 28.
•   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.
•   Haybittle JL
  Repeated assessment of results in clinical trials of cancer treatment. Br J Radiol. 1971 Oct;44(526):793-7.
•   Hayes, R
  & Moulton, L. Cluster randomized trials. (Chapman & Hall/CRC, 2009)
•   Hilgenboecker K, Hammerstein P, Schlattmann P, Telschow A, Werren JH
  How many species are infected with Wolbachia?--A statistical analysis of current data. FEMS Microbiol Lett. 2008 Apr;281(2):215-20. doi: 10.1111/j.1574-6968.2008.01110.x. Epub 2008 Feb 28.
•   Ivers NM, Halperin IJ, Barnsley J, Grimshaw JM, Shah BR, Tu K, Upshur R, Zwarenstein M
  Allocation techniques for balance at baseline in cluster randomized trials: a methodological review. Trials. 2012 Aug 1;13:120. doi: 10.1186/1745-6215-13-120. Review.
•   Jackson ML, Nelson JC
  The test-negative design for estimating influenza vaccine effectiveness. Vaccine. 2013 Apr 19;31(17):2165-8. doi: 10.1016/j.vaccine.2013.02.053. Epub 2013 Mar 13.
•   Johnson KN
  The Impact of Wolbachia on Virus Infection in Mosquitoes. Viruses. 2015 Nov 4;7(11):5705-17. doi: 10.3390/v7112903. Review.
•   Joubert DA, Walker T, Carrington LB, De Bruyne JT, Kien DH, Hoang Nle T, Chau NV, Iturbe-Ormaetxe I, Simmons CP, O'Neill SL
  Establishment of a Wolbachia Superinfection in Aedes aegypti Mosquitoes as a Potential Approach for Future Resistance Management. PLoS Pathog. 2016 Feb 18;12(2):e1005434. doi: 10.1371/journal.ppat.1005434. eCollection 2016 Feb.
•   Karyanti MR, Uiterwaal CS, Kusriastuti R, Hadinegoro SR, Rovers MM, Heesterbeek H, Hoes AW, Bruijning-Verhagen P
  The changing incidence of dengue haemorrhagic fever in Indonesia: a 45-year registry-based analysis. BMC Infect Dis. 2014 Jul 26;14:412. doi: 10.1186/1471-2334-14-412.
•   Kosasih H, de Mast Q, Widjaja S, Sudjana P, Antonjaya U, Ma'roef C, Riswari SF, Porter KR, Burgess TH, Alisjahbana B, van der Ven A, Williams M
  Evidence for endemic chikungunya virus infections in Bandung, Indonesia. PLoS Negl Trop Dis. 2013 Oct 24;7(10):e2483. doi: 10.1371/journal.pntd.0002483. eCollection 2013.
•   Kwong JC, Druce JD, Leder K
  Zika virus infection acquired during brief travel to Indonesia. Am J Trop Med Hyg. 2013 Sep;89(3):516-7. doi: 10.4269/ajtmh.13-0029. Epub 2013 Jul 22.
•   L'Azou M, Moureau A, Sarti E, Nealon J, Zambrano B, Wartel TA, Villar L, Capeding MR, Ochiai RL; CYD14 Primary Study Group; CYD15 Primary Study Group
  Symptomatic Dengue in Children in 10 Asian and Latin American Countries. N Engl J Med. 2016 Mar 24;374(12):1155-66. doi: 10.1056/NEJMoa1503877.
•   Laras K, Sukri NC, Larasati RP, Bangs MJ, Kosim R, Djauzi, Wandra T, Master J, Kosasih H, Hartati S, Beckett C, Sedyaningsih ER, Beecham HJ 3rd, Corwin AL
  Tracking the re-emergence of epidemic chikungunya virus in Indonesia. Trans R Soc Trop Med Hyg. 2005 Feb;99(2):128-41.
•   Leung GH, Baird RW, Druce J, Anstey NM
  ZIKA VIRUS INFECTION IN AUSTRALIA FOLLOWING A MONKEY BITE IN INDONESIA. Southeast Asian J Trop Med Public Health. 2015 May;46(3):460-4.
•   McMeniman CJ, Lane RV, Cass BN, Fong AW, Sidhu M, Wang YF, O'Neill SL
  Stable introduction of a life-shortening Wolbachia infection into the mosquito Aedes aegypti. Science. 2009 Jan 2;323(5910):141-4. doi: 10.1126/science.1165326.
•   Moreira LA, Iturbe-Ormaetxe I, Jeffery JA, Lu G, Pyke AT, Hedges LM, Rocha BC, Hall-Mendelin S, Day A, Riegler M, Hugo LE, Johnson KN, Kay BH, McGraw EA, van den Hurk AF, Ryan PA, O'Neill SL
  A Wolbachia symbiont in Aedes aegypti limits infection with dengue, Chikungunya, and Plasmodium. Cell. 2009 Dec 24;139(7):1268-78. doi: 10.1016/j.cell.2009.11.042.
•   Mulyatno KC, Susilowati H, Yamanaka A, Soegijanto S, Konishi E
  Primary isolation and phylogenetic studies of Chikungunya virus from Surabaya, Indonesia. Jpn J Infect Dis. 2012;65(1):92-4.
•   O'Neill SL, Pettigrew MM, Sinkins SP, Braig HR, Andreadis TG, Tesh RB
  In vitro cultivation of Wolbachia pipientis in an Aedes albopictus cell line. Insect Mol Biol. 1997 Feb;6(1):33-9.
•   Perkasa A, Yudhaputri F, Haryanto S, Hayati RF, Ma'roef CN, Antonjaya U, Yohan B, Myint KS, Ledermann JP, Rosenberg R, Powers AM, Sasmono RT
  Isolation of Zika Virus from Febrile Patient, Indonesia. Emerg Infect Dis. 2016 May;22(5):924-5. doi: 10.3201/eid2205.151915.
•   Pilger, D
  , De Maesschalck, M., Horstick, O. & San Martín, J. L. Dengue outbreak response: documented effective interventions and evidence gaps. TropIKA 1, (2010)
•   Porter KR, Tan R, Istary Y, Suharyono W, Sutaryo, Widjaja S, Ma'Roef C, Listiyaningsih E, Kosasih H, Hueston L, McArdle J, Juffrie M
  A serological study of Chikungunya virus transmission in Yogyakarta, Indonesia: evidence for the first outbreak since 1982. Southeast Asian J Trop Med Public Health. 2004 Jun;35(2):408-15.
•   Rainey SM, Shah P, Kohl A, Dietrich I
  Understanding the Wolbachia-mediated inhibition of arboviruses in mosquitoes: progress and challenges. J Gen Virol. 2014 Mar;95(Pt 3):517-530. doi: 10.1099/vir.0.057422-0. Epub 2013 Dec 16. Review.
•   Ramadona AL, Lazuardi L, Hii YL, Holmner Å, Kusnanto H, Rocklöv J
  Prediction of Dengue Outbreaks Based on Disease Surveillance and Meteorological Data. PLoS One. 2016 Mar 31;11(3):e0152688. doi: 10.1371/journal.pone.0152688. eCollection 2016.
•   Riswari SF, Ma'roef CN, Djauhari H, Kosasih H, Perkasa A, Yudhaputri FA, Artika IM, Williams M, van der Ven A, Myint KS, Alisjahbana B, Ledermann JP, Powers AM, Jaya UA
  Study of viremic profile in febrile specimens of chikungunya in Bandung, Indonesia. J Clin Virol. 2016 Jan;74:61-5. doi: 10.1016/j.jcv.2015.11.017. Epub 2015 Nov 17.
•   Rolph MS, Foo SS, Mahalingam S
  Emergent chikungunya virus and arthritis in the Americas. Lancet Infect Dis. 2015 Sep;15(9):1007-1008. doi: 10.1016/S1473-3099(15)00231-5.
•   Rousset F, Vautrin D, Solignac M
  Molecular identification of Wolbachia, the agent of cytoplasmic incompatibility in Drosophila simulans, and variability in relation with host mitochondrial types. Proc Biol Sci. 1992 Mar 23;247(1320):163-8.
•   Schilte C, Staikowsky F, Couderc T, Madec Y, Carpentier F, Kassab S, Albert ML, Lecuit M, Michault A
  Chikungunya virus-associated long-term arthralgia: a 36-month prospective longitudinal study. PLoS Negl Trop Dis. 2013;7(3):e2137. doi: 10.1371/journal.pntd.0002137. Epub 2013 Mar 21. Erratum in: PLoS Negl Trop Dis. 2013 Mar;7(3). doi:10.1371/annotation/850ee20f-2641-46ac-b0c6-ef4ae79b6de6. Staikovsky, Frédérik [corrected to Staikowsky, Frederik].
•   Shepard DS, Coudeville L, Halasa YA, Zambrano B, Dayan GH
  Economic impact of dengue illness in the Americas. Am J Trop Med Hyg. 2011 Feb;84(2):200-7. doi: 10.4269/ajtmh.2011.10-0503.
•   Shepard DS, Suaya JA, Halstead SB, Nathan MB, Gubler DJ, Mahoney RT, Wang DN, Meltzer MI
  Cost-effectiveness of a pediatric dengue vaccine. Vaccine. 2004 Mar 12;22(9-10):1275-80.
•   Shepard DS, Undurraga EA, Halasa YA
  Economic and disease burden of dengue in Southeast Asia. PLoS Negl Trop Dis. 2013;7(2):e2055. doi: 10.1371/journal.pntd.0002055. Epub 2013 Feb 21. Review.
•   Smith PG, Morrow RH, Ross DA, editors
  Field Trials of Health Interventions: A Toolbox. 3rd edition. Oxford (UK): OUP Oxford; 2015 Jun 1.
•   Stouthamer R, Breeuwer JA, Hurst GD
  Wolbachia pipientis: microbial manipulator of arthropod reproduction. Annu Rev Microbiol. 1999;53:71-102. Review.
•   Vandenbroucke JP, Pearce N
  Case-control studies: basic concepts. Int J Epidemiol. 2012 Oct;41(5):1480-9. doi: 10.1093/ije/dys147.
•   Villar L, Dayan GH, Arredondo-García JL, Rivera DM, Cunha R, Deseda C, Reynales H, Costa MS, Morales-Ramírez JO, Carrasquilla G, Rey LC, Dietze R, Luz K, Rivas E, Miranda Montoya MC, Cortés Supelano M, Zambrano B, Langevin E, Boaz M, Tornieporth N, Saville M, Noriega F; CYD15 Study Group
  Efficacy of a tetravalent dengue vaccine in children in Latin America. N Engl J Med. 2015 Jan 8;372(2):113-23. doi: 10.1056/NEJMoa1411037. Epub 2014 Nov 3.
•   Walker T, Johnson PH, Moreira LA, Iturbe-Ormaetxe I, Frentiu FD, McMeniman CJ, Leong YS, Dong Y, Axford J, Kriesner P, Lloyd AL, Ritchie SA, O'Neill SL, Hoffmann AA
  The wMel Wolbachia strain blocks dengue and invades caged Aedes aegypti populations. Nature. 2011 Aug 24;476(7361):450-3. doi: 10.1038/nature10355.
•   Weaver SC, Costa F, Garcia-Blanco MA, Ko AI, Ribeiro GS, Saade G, Shi PY, Vasilakis N
  Zika virus: History, emergence, biology, and prospects for control. Antiviral Res. 2016 Jun;130:69-80. doi: 10.1016/j.antiviral.2016.03.010. Epub 2016 Mar 18. Review.
•   Wilson AL, Boelaert M, Kleinschmidt I, Pinder M, Scott TW, Tusting LS, Lindsay SW
  Evidence-based vector control? Improving the quality of vector control trials. Trends Parasitol. 2015 Aug;31(8):380-90. doi: 10.1016/j.pt.2015.04.015. Epub 2015 May 19. Review.
•   Wolbers M, Kleinschmidt I, Simmons CP, Donnelly CA
  Considerations in the design of clinical trials to test novel entomological approaches to dengue control. PLoS Negl Trop Dis. 2012;6(11):e1937. doi: 10.1371/journal.pntd.0001937. Epub 2012 Nov 29.
•   World Health Organization
  Mosquito (vector) control emergency response and preparedness for Zika virus. (2016). Available at: http://www.who.int/neglected_diseases/news/mosquito_vector_control_response/en/. (Accessed: 18th March 2016)
•   World Health Organization
  Outcome of the Emergency Committee regarding clusters of microcephaly and Guillain-Barre syndrome. (2016)
•   Ye YH, Carrasco AM, Frentiu FD, Chenoweth SF, Beebe NW, van den Hurk AF, Simmons CP, O'Neill SL, McGraw EA
  Wolbachia Reduces the Transmission Potential of Dengue-Infected Aedes aegypti. PLoS Negl Trop Dis. 2015 Jun 26;9(6):e0003894. doi: 10.1371/journal.pntd.0003894. eCollection 2015.

Applying Wolbachia to Eliminate Dengue (AWED): A Non-blinded Cluster Randomised Controlled Trial to Assess the Efficacy of Wolbachia-infected Mosquito Deployments to Reduce Dengue Incidence in Yogyakarta, Indonesia

Details for clinical trial NCT03055585