Immunogenicity and safety of lyophilized and liquid dengue tetravalent vaccine candidate formulations in healthy adults: a randomized, phase 2 clinical trial

References

• Guzman MG, Harris E. Dengue. Lancet. 2015;385:453–65. doi:10.1016/S0140-6736(14)60572-9.
   PubMed Web of Science ®Google Scholar
• Dengue vaccine: WHO position paper - July 2016.World Health Organization.Wkly Epidemiol Rec. 2016;91:349–64.
   PubMedGoogle Scholar
• Brady OJ, Gething PW, Bhatt S, Messina JP, Brownstein JS, Hoen AG, Moyes CL, Farlow AW, Scott TW, Hay SI, et al. Refining the global spatial limits of dengue virus transmission by evidence-based consensus. PLoS Negl Trop Dis. 2012;6:e1760. doi:10.1371/journal.pntd.0001760.
   PubMed Web of Science ®Google Scholar
• Beatty ME, Beutels P, Meltzer MI, Shepard DS, Hombach J, Hutubessy R, Dervaux B, Wichmann O, Meltzer MI, Kuritsky JN, et al. Health economics of dengue: a systematic literature review and expert panel’s assessment. Am J Trop Med Hyg. 2011;84:473–88. doi:10.4269/ajtmh.2011.10-0521.
   PubMed Web of Science ®Google Scholar
• Bhatt S, Gething PW, Brady OJ, Messina JP, Farlow AW, Moyes CL, Drake JM, Brownstein JS, Hoen AG, Sankoh O, et al. The global distribution and burden of dengue. Nature. 2013;496:504–07. doi:10.1038/nature12060.
   PubMed Web of Science ®Google Scholar
• Stanaway JD, Shepard DS, Undurraga EA, Halasa YA, Coffeng LE, Brady OJ, Hay SI, Bedi N, Bensenor IM, Castañeda-Orjuela CA, et al. The global burden of dengue: an analysis from the global burden of disease study 2013. Lancet Infect Dis. 2016;16:712–23. doi:10.1016/S1473-3099(16)00026-8.
   PubMed Web of Science ®Google Scholar
• World Health Organization. Dengue guidelines for diagnosis, treatment, prevention and control: new edition. Geneva (Switzerland); 2009 accessed 2020 January 7. http://apps.who.int/iris/bitstream/handle/10665/44188/9789241547871_eng.pdf?sequence=1&isAllowed=y.
   Google Scholar
• Guzman MG, Alvarez M, Halstead SB. Secondary infection as a risk factor for dengue hemorrhagic fever/dengue shock syndrome: an historical perspective and role of antibody-dependent enhancement of infection. Arch Virol. 2013;158:1445–59. doi:10.1007/s00705-013-1645-3.
   PubMed Web of Science ®Google Scholar
• World Health Organization. Dengue and severe dengue. April 2019 [accessed 2020 January 7]. http://www.who.int/news-room/fact-sheets/detail/dengue-and-severe-dengue.
   Google Scholar
• World Health Organization. Policy recommendations on the use of the first licensed dengue vaccine. Weekly Epidemiol Rec. 2018;93:337–40.
   Google Scholar
• Osorio JE, Huang CY, Kinney RM, Stinchcomb DT. Development of DENVax: a chimeric dengue-2 PDK-53-based tetravalent vaccine for protection against dengue fever. Vaccine. 2011;29:7251–60. doi:10.1016/j.vaccine.2011.07.020.
   PubMed Web of Science ®Google Scholar
• George SL, Wong MA, Dube TJ, Boroughs KL, Stovall JL, Luy BE, Haller AA, Osorio JE, Eggemeyer LM, Irby-Moore S, et al. Safety and immunogenicity of a live attenuated tetravalent dengue vaccine candidate in flavivirus-naive adults: a randomized, double-blinded phase 1 clinical trial. J Infect Dis. 2015;212:1032–41. doi:10.1093/infdis/jiv179.
   PubMed Web of Science ®Google Scholar
• Osorio JE, Velez ID, Thomson C, Lopez L, Jimenez A, Haller AA, Silengo S, Scott J, Boroughs KL, Stovall JL, et al. Safety and immunogenicity of a recombinant live attenuated tetravalent dengue vaccine (DENVax) in flavivirus-naive healthy adults in Colombia: a randomised, placebo-controlled, phase 1 study. Lancet Infect Dis. 2014;14:830–38. doi:10.1016/S1473-3099(14)70811-4.
   PubMed Web of Science ®Google Scholar
• Rupp R, Luckasen GJ, Kirstein JL, Osorio JE, Santangelo JD, Raanan M, Smith MK, Wallace D, Gordon GS, Stinchcomb DT, et al. Safety and immunogenicity of different doses and schedules of a live attenuated tetravalent dengue vaccine (TDV) in healthy adults: a Phase 1b randomized study. Vaccine. 2015;33:6351–59. doi:10.1016/j.vaccine.2015.09.008.
   PubMed Web of Science ®Google Scholar
• Sirivichayakul C, Barranco-Santana EA, Esquilin-Rivera I, Oh HML, Raanan M, Sariol CA, Shek LP, Simasathien S, Smith MK, Velez ID, et al. Safety and immunogenicity of a tetravalent dengue vaccine candidate in healthy children and adults in dengue-endemic regions: a randomized, placebo-controlled phase 2 study. J Infect Dis. 2016;213:1562–72. doi:10.1093/infdis/jiv762.
   PubMed Web of Science ®Google Scholar
• Jackson LA, Rupp R, Papadimitriou A, Wallace D, Raanan M, Mosse KJ. A phase 1 study of safety and immunogenicity following intradermal administration of a tetravalent dengue vaccine candidate. Vaccine. 2018;36:3976–83. doi:10.1016/j.vaccine.2018.05.028.
   PubMed Web of Science ®Google Scholar
• World Health Organization. Assessing the programmatic suitability of vaccine candidates for WHO prequalification - revision 2014. Geneva (Switzerland); 2015 accessed 2020 January 7. http://apps.who.int/iris/bitstream/handle/10665/148168/WHO_IVB_14.10_eng.pdf?sequence=1.
   Google Scholar
• Roehrig JT, Hombach J, Barrett AD. Guidelines for plaque-reduction neutralization testing of human antibodies to dengue viruses. Viral Immunol. 2008;21:123–32. doi:10.1089/vim.2008.0007.
   PubMed Web of Science ®Google Scholar
• Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987;15:657–80. doi:10.1007/BF01068419.
   PubMedGoogle Scholar
• Tricou V, Low JG, Oh HM, Leo YS, Kalimuddin S, Wijaya L, Pang J, Ling LM, Lee TH, Brose M, et al. Safety and immunogenicity of a single dose of a tetravalent dengue vaccine with two differentserotype-2 potencies in adults in Singapore: A phase 2, double-blind, randomised, controlled trial. Vaccine. 2019. doi:10.1016/j.vaccine.2019.11.061.
   PubMed Web of Science ®Google Scholar
• Saez-Llorens X, Tricou V, Yu D, Rivera L, Tuboi S, Garbes P, Borkowski A, Wallace D. Safety and immunogenicity of one versus two doses of Takeda’s tetravalent dengue vaccine in children in Asia and Latin America: interim results from a phase 2, randomised, placebo-controlled study. Lancet Infect Dis. 2017;17:615–25. doi:10.1016/S1473-3099(17)30166-4.
   PubMed Web of Science ®Google Scholar
• Saez-Llorens X, Tricou V, Yu D, Rivera L, Jimeno J, Villarreal AC, Dato E, Mazara S, Vargas M, Brose M, et al. Immunogenicity and safety of one versus two doses of tetravalent dengue vaccine in healthy children aged 2–17 years in Asia and Latin America: 18-month interim data from a phase 2, randomised, placebo-controlled study. Lancet Infect Dis. 2018;18:162–70. doi:10.1016/S1473-3099(17)30632-1.
   PubMed Web of Science ®Google Scholar
• Biswal S, Reynales H, Saez-Llorens X, Lopez P, Borja-Tabora C, Kosalaraksa P, Sirivichayakul C, Watanaveeradej V, Rivera L, Espinoza F, et al. Efficacy of a tetravalent dengue vaccine in healthy children and adolescents. N Engl J Med. 2019;381:2009–19. doi:10.1056/NEJMoa1903869.
   PubMed Web of Science ®Google Scholar
• Chu H, George SL, Stinchcomb DT, Osorio JE, Partidos CD. CD8+ T-cell responses in flavivirus-naive individuals following immunization with a live-attenuated tetravalent dengue vaccine candidate. J Infect Dis. 2015;212:1618–28. doi:10.1093/infdis/jiv258.
   PubMed Web of Science ®Google Scholar
• Osorio JE, Wallace D, Stinchcomb DT. A recombinant, chimeric tetravalent dengue vaccine candidate based on a dengue virus serotype 2 backbone. Expert Rev Vaccines. 2016;15:497–508. doi:10.1586/14760584.2016.1128328.
   PubMed Web of Science ®Google Scholar