Author:
- INTRODUCTION
- MATERIALS AND METHODS
- CYD14 and CYD15 trials.
- CYD22 and CYD47 trials.
- 50% plaque reduction neutralization test assay.
- Statistical analysis.
- Non-inferiority of month 13 neutralizing responses in 18- to 45-year-olds versus 9- to 16-year-olds.
- Estimating VE in 18- to- 45-year-olds.
- Method 2a: Serotype-specific VE objective based on month 0 and 13 serotype titers.
- Method 2b: Serotype-specific VE objective based on month 0 serotype titers.
- Method 1a: Overall VE objective based on month 0 and 13 serotype titers.
- Method 1b: Overall VE objective based on month 0 serotype titers.
- Method 1c: Overall VE objective based on month 0 and 13 average titers.
- Method 1d: Overall VE objective based on month 0 average titers.
- Key assumptions of the bridging methods.
- CIs about VE in the 18- to 45-year-old cohorts.
- Sensitivity analysis to possible violations of assumptions 1 and 3.
- RESULTS
- Non-inferiority of month 13 neutralizing responses in 18- to 45-year-olds versus 9–16-year-olds.
- Non-inferiority of month 0 neutralizing responses in 18- to 45-year-olds versus 9- to 16-year-olds.
- Estimated VE against VCD 0–25 months in 18- to 45-year-olds.
- Estimated VE against hospitalized VCD 0–72 months in 18- to 45-year-olds.
- Sensitivity analysis for estimated VE against VCD 0–25 months in 18- to 45-year-olds.
- Sensitivity analysis for estimated VE against hospitalized VCD 0–72 months in 18- to 45-year-olds.
- DISCUSSION
- Supplemental tables and figures
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
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Thai KT, Binh TQ, Giao PT, Phuong HL, Hung le Q, Van Nam N, Nga TT, Groen J, Nagelkerke N, de Vries PJ, 2005. Seroprevalence of dengue antibodies, annual incidence and risk factors among children in southern Vietnam. Trop Med Int Health 10: 379–386.
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Chew CH et al. 2016. Rural-urban comparisons of dengue seroprevalence in Malaysia. BMC Public Health 16: 824.
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Rodriguez-Barraquer I, Buathong R, Iamsirithaworn S, Nisalak A, Lessler J, Jarman RG, Gibbons RV, Cummings DA, 2014. Revisiting Rayong: shifting seroprofiles of dengue in Thailand and their implications for transmission and control. Am J Epidemiol 179: 353–360.
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Carabali M, Hernandez LM, Arauz MJ, Villar LA, Ridde V, 2015. Why are people with dengue dying? A scoping review of determinants for dengue mortality. BMC Infect Dis 15: 301.
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Sam SS, Omar SF, Teoh BT, Abd-Jamil J, AbuBakar S, 2013. Review of dengue hemorrhagic fever fatal cases seen among adults: a retrospective study. PLoS Negl Trop Dis 7: e2194.
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Moraes GH, de Fatima Duarte E, Duarte EC, 2013. Determinants of mortality from severe dengue in Brazil: a population-based case-control study. Am J Trop Med Hyg 88: 670–676.
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Egger JR, Coleman PG, 2007. Age and clinical dengue illness. Emerg Infect Dis 13: 924–925.
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Thai KT, Nishiura H, Hoang PL, Tran NT, Phan GT, Le HQ, Tran BQ, Nguyen NV, de Vries PJ, 2011. Age-specificity of clinical dengue during primary and secondary infections. PLoS Negl Trop Dis 5: e1180.
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Juraska M et al. 2018. Viral genetic diversity and protective efficacy of a tetravalent dengue vaccine in two phase 3 trials. Proc Natl Acad Sci USA 115: E8378–E8387.
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Moodie Z et al. 2018. Neutralizing antibody correlates analysis of tetravalent dengue vaccine efficacy trials in Asia and Latin America. J Infect Dis 217: 742–753.
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Hadinegoro SR et al. 2015. Efficacy and long-term safety of a dengue vaccine in regions of endemic disease. N Engl J Med 373: 1195–1206.
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Sridhar S et al. 2018. Effect of dengue serostatus on dengue vaccine safety and efficacy. N Engl J Med 379: 327–340.
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Bridging Efficacy of a Tetravalent Dengue Vaccine from Children/Adolescents to Adults in Highly Endemic Countries Based on Neutralizing Antibody Response
Peter B. Gilbert
Peter B. Gilbert
Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington;
Department of Biostatistics, University of Washington, Seattle, Washington;
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Department of Biostatistics, University of Washington, Seattle, Washington;
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Ying Huang
Ying Huang
Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington;
Department of Biostatistics, University of Washington, Seattle, Washington;
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Department of Biostatistics, University of Washington, Seattle, Washington;
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Michal Juraska
Michal Juraska
Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington;
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Zoe Moodie
Zoe Moodie
Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington;
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Youyi Fong
Youyi Fong
Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington;
Department of Biostatistics, University of Washington, Seattle, Washington;
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Department of Biostatistics, University of Washington, Seattle, Washington;
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Alexander Luedtke
Alexander Luedtke
Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington;
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Yingying Zhuang
Yingying Zhuang
Department of Biostatistics, University of Washington, Seattle, Washington;
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Jason Shao
Jason Shao
Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington;
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Lindsay N. Carpp
Lindsay N. Carpp
Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington;
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Nicholas Jackson
Nicholas Jackson
Research and Non Clinical Safety, Sanofi Pasteur, Marcy-L’Etoile, France;
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Laurent Chambonneau
Laurent Chambonneau
Clinical Programs, Sanofi Pasteur, Marcy-L’Etoile, France;
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Alain Bouckenooghe
Alain Bouckenooghe
Clinical Sciences, Sanofi Pasteur, Singapore;
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Betzana Zambrano
Betzana Zambrano
Clinical Sciences, Sanofi Pasteur, Montevideo, Uruguay;
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Carina Frago
Carina Frago
Clinical Sciences, Sanofi Pasteur, Singapore;
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Sophie Pallardy
Sophie Pallardy
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Fernando Noriega
Fernando Noriega
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The CYD-TDV vaccine is licensed in multiple endemic countries based on vaccine efficacy (VE) against symptomatic, virologically confirmed dengue demonstrated in two phase 3 trials (CYD14, 2- to 14-year-olds, Asia; CYD15, 9- to 16-year-olds, Latin America). 50% plaque reduction neutralization test (PRNT50) titers at baseline and month 13 (post-vaccination) were associated with VE and may enable bridging VE to adults. Two phase 2 trials of CYD-TDV measured baseline and month 13 PRNT50 titers: CYD22 (9- to 45-year-olds, Vietnam) and CYD47 (18- to 45-year-olds, India). 50% plaque reduction neutralization test distributions were compared between age cohorts, and four versions of an epidemiological bridging method were used to estimate VE against any serotype (dengue virus [DENV]-Any) and against each serotype over 25 months post first vaccination in a hypothetical CYD14 + CYD15 18- to 45-year-old cohort (bridging population 1) and in the actual CYD47 18- to 45-year-old cohort (bridging population 2). Baseline and month 13 geometric mean PRNT50 titers to each serotype were significantly greater in 18- to 45-year-olds than 9- to 16-year-olds for all comparisons. The four methods estimated VE against DENV-Any at 75.3–86.0% (95% CIs spanning 52.5–100%) for bridging population 1 and 68.4–77.5% (95% CIs spanning 42.3–88.5%) for bridging population 2. The vaccine efficacy against serotype 1, 2, 3, and 4 was estimated at 56.9–76.9%, 68.3–85.8%, 91.4–95.0%, and 93.2–100% (bridging population 1) and 44.5–66.9%, 53.2–69.2%, 79.8–92.0%, and 90.6–95.0% (bridging population 2), respectively; thus, CYD-TDV would likely confer improved efficacy in adults than 9- to 16-year-olds. Using the same methods, we predicted VE against hospitalized DENV-Any over 72 months of follow-up, with estimates 59.1–73.5% (95% CIs spanning 40.9–92.2%) for bridging population 1 and 50.9–65.9% (95% CIs spanning 38.1–82.1%) for bridging population 2.
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Author Notes
Disclosures: N. J., L. C., A. B., B. Z., C. F., S. P., and F. N. are employees of Sanofi Pasteur. B. Z., F. N., L. C., A. B., and C. F. own stocks in Sanofi Pasteur, and N. J. has long-term incentives for Sanofi Pasteur. P. B. G., Y. H., M. J., Z. M., Y. F., A. L., Y. Z., J. S., and L. N. C. received a contract from Sanofi Pasteur to conduct the statistical analysis work. P. B. G., M. J., and Y. F. received support for travel to meetings from Sanofi Pasteur, and P. B. G. served as an unpaid consultant to Sanofi Pasteur at Advisory meetings in June and November of 2017.
Financial support: This work was supported by Sanofi Pasteur (www.sanofipasteur.us) through a contract to P. B. G. and by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services, under award number R37AI054165 to P. B. G.
Authors’ addresses: Peter B. Gilbert, Ying Huang, and Youyi Fong, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA, E-mails: pgilbert@fredhutch.org, yhuang@fhcrc.org, and yfong@fredhutch.org. Michal Juraska, Zoe Moodie, Alexander Luedtke, Jason Shao, and Lindsay N. Carpp, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, E-mails: mjuraska@fhcrc.org, zoe@fredhutch.org, aluedtke@fredhutch.org, jshao@fredhutch.org, and lcarpp@fredhutch.org. Yingying Zhuang, University of Washington, Seattle, WA, E-mail: yyzhuang@uw.edu. Nicholas Jackson, Laurent Chambonneau, Sophie Pallardy, Sanofi Pasteur, Marcy-L’Etoile, France, E-mails: nicholas.jackson@sanofi.com, laurent.chambonneau@sanofi.com, and sophie.pallardy@sanofi.com. Alain Bouckenooghe and Carina Frago, Sanofi Pasteur, Singapore, E-mails: alain.bouckenooghe@sanofi.com and carina.frago@sanofi.com. Betzana Zambrano, Sanofi Pasteur, Montevideo, Uruguay, E-mail: betzana.zambrano@sanofi.com. Fernando Noriega, Sanofi Pasteur, Swiftwater, PA, E-mail: fernando.noriega@sanofi.com.
These authors contributed equally to this work.
- INTRODUCTION
- MATERIALS AND METHODS
- CYD14 and CYD15 trials.
- CYD22 and CYD47 trials.
- 50% plaque reduction neutralization test assay.
- Statistical analysis.
- Non-inferiority of month 13 neutralizing responses in 18- to 45-year-olds versus 9- to 16-year-olds.
- Estimating VE in 18- to- 45-year-olds.
- Method 2a: Serotype-specific VE objective based on month 0 and 13 serotype titers.
- Method 2b: Serotype-specific VE objective based on month 0 serotype titers.
- Method 1a: Overall VE objective based on month 0 and 13 serotype titers.
- Method 1b: Overall VE objective based on month 0 serotype titers.
- Method 1c: Overall VE objective based on month 0 and 13 average titers.
- Method 1d: Overall VE objective based on month 0 average titers.
- Key assumptions of the bridging methods.
- CIs about VE in the 18- to 45-year-old cohorts.
- Sensitivity analysis to possible violations of assumptions 1 and 3.
- RESULTS
- Non-inferiority of month 13 neutralizing responses in 18- to 45-year-olds versus 9–16-year-olds.
- Non-inferiority of month 0 neutralizing responses in 18- to 45-year-olds versus 9- to 16-year-olds.
- Estimated VE against VCD 0–25 months in 18- to 45-year-olds.
- Estimated VE against hospitalized VCD 0–72 months in 18- to 45-year-olds.
- Sensitivity analysis for estimated VE against VCD 0–25 months in 18- to 45-year-olds.
- Sensitivity analysis for estimated VE against hospitalized VCD 0–72 months in 18- to 45-year-olds.
- DISCUSSION
- Supplemental tables and figures
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
1.
Murray NE, Quam MB, Wilder-Smith A, 2013. Epidemiology of dengue: past, present and future prospects. Clin Epidemiol 5: 299–309.
-
2.
World Health Organization, 2012. World Health Organization (WHO) Global Strategy for Dengue Prevention and Control, 2012–2020. Geneva, Switzerland: WHO Press.
-
3.
Bhatt S et al. 2013. The global distribution and burden of dengue. Nature 496: 504–507.
-
4.
Brady OJ, Gething PW, Bhatt S, Messina JP, Brownstein JS, Hoen AG, Moyes CL, Farlow AW, Scott TW, Hay SI, 2012. Refining the global spatial limits of dengue virus transmission by evidence-based consensus. PLoS Negl Trop Dis 6: e1760.
-
5.
Thai KT, Binh TQ, Giao PT, Phuong HL, Hung le Q, Van Nam N, Nga TT, Groen J, Nagelkerke N, de Vries PJ, 2005. Seroprevalence of dengue antibodies, annual incidence and risk factors among children in southern Vietnam. Trop Med Int Health 10: 379–386.
-
6.
Low SL, Lam S, Wong WY, Teo D, Ng LC, Tan LK, 2015. Dengue seroprevalence of healthy adults in Singapore: serosurvey among blood donors, 2009. Am J Trop Med Hyg 93: 40–45.
-
7.
Chew CH et al. 2016. Rural-urban comparisons of dengue seroprevalence in Malaysia. BMC Public Health 16: 824.
-
8.
Rodriguez-Barraquer I, Buathong R, Iamsirithaworn S, Nisalak A, Lessler J, Jarman RG, Gibbons RV, Cummings DA, 2014. Revisiting Rayong: shifting seroprofiles of dengue in Thailand and their implications for transmission and control. Am J Epidemiol 179: 353–360.
-
9.
Carabali M, Hernandez LM, Arauz MJ, Villar LA, Ridde V, 2015. Why are people with dengue dying? A scoping review of determinants for dengue mortality. BMC Infect Dis 15: 301.
-
10.
Sam SS, Omar SF, Teoh BT, Abd-Jamil J, AbuBakar S, 2013. Review of dengue hemorrhagic fever fatal cases seen among adults: a retrospective study. PLoS Negl Trop Dis 7: e2194.
-
11.
Moraes GH, de Fatima Duarte E, Duarte EC, 2013. Determinants of mortality from severe dengue in Brazil: a population-based case-control study. Am J Trop Med Hyg 88: 670–676.
-
12.
Egger JR, Coleman PG, 2007. Age and clinical dengue illness. Emerg Infect Dis 13: 924–925.
-
13.
Thai KT, Nishiura H, Hoang PL, Tran NT, Phan GT, Le HQ, Tran BQ, Nguyen NV, de Vries PJ, 2011. Age-specificity of clinical dengue during primary and secondary infections. PLoS Negl Trop Dis 5: e1180.
-
14.
Guy B, Lang J, Saville M, Jackson N, 2016. Vaccination against dengue: challenges and current developments. Annu Rev Med 67: 387–404.
-
15.
Villar L et al. 2015. Efficacy of a tetravalent dengue vaccine in children in Latin America. N Engl J Med 372: 113–123.
-
16.
Capeding MR et al. 2014. 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 384: 1358–1365.
-
17.
Juraska M et al. 2018. Viral genetic diversity and protective efficacy of a tetravalent dengue vaccine in two phase 3 trials. Proc Natl Acad Sci USA 115: E8378–E8387.
-
18.
Moodie Z et al. 2018. Neutralizing antibody correlates analysis of tetravalent dengue vaccine efficacy trials in Asia and Latin America. J Infect Dis 217: 742–753.
-
19.
Hadinegoro SR et al. 2015. Efficacy and long-term safety of a dengue vaccine in regions of endemic disease. N Engl J Med 373: 1195–1206.
-
20.
Sridhar S et al. 2018. Effect of dengue serostatus on dengue vaccine safety and efficacy. N Engl J Med 379: 327–340.
-
21.
Mizumoto K, Ejima K, Yamamoto T, Nishiura H, 2014. On the risk of severe dengue during secondary infection: a systematic review coupled with mathematical modeling. J Vector Borne Dis 51: 153–164.
-
22.
Pancharoen C, Mekmullica J, Thisyakorn U, 2001. Primary dengue infection: what are the clinical distinctions from secondary infection? Southeast Asian J Trop Med Public Health 32: 476–480.
-
23.
Endy TP, Yoon IK, Mammen MP, 2010. Prospective cohort studies of dengue viral transmission and severity of disease. Curr Top Microbiol Immunol 338: 1–13.
-
24.
Guy B, Jackson N, 2016. Dengue vaccine: hypotheses to understand CYD-TDV-induced protection. Nat Rev Microbiol 14: 45–54.
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