Detection of dengue cases by serological testing in a dengue vaccine efficacy trial: Utility for efficacy evaluation and impact of future vaccine introduction

Vaccine

Volumn 34, Issue 24, 2016, Pages 2707-2712

  Plennevaux, Eric ^a   Sabchareon, Arunee ^b   Limkittikul, Kriengsak ^b   Chanthavanich, Pornthep ^b   Sirivichayakul, Chukiat ^b   Moureau, Annick ^a   Boaz, Mark ^a   Wartel, T Anh ^c   Saville, Melanie ^a   Bouckenooghe, Alain ^c  

^a SANOFI PASTEUR   (France)

^b MAHIDOL UNIVERSITY   (Thailand)

^c Sanofi Pasteur   (Singapore)

Author keywords

Dengue; Flavivirus; Serology; Vaccine

Indexed keywords

DENGUE VACCINE; IMMUNOGLOBULIN G; IMMUNOGLOBULIN M; LIVE VACCINE; NONSTRUCTURAL PROTEIN 1; PLACEBO; RECOMBINANT YELLOW FEVER 17D DENGUE VACCINE; TETRAVALENT DENGUE VACCINE; UNCLASSIFIED DRUG; NS1 PROTEIN, DENGUE-1 VIRUS; VIRAL PROTEIN; VIRUS ANTIBODY;

ANTIBODY RESPONSE; ARTICLE; CHILD; CLINICAL EVALUATION; CONTROLLED STUDY; CONVALESCENCE; DENGUE; DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST ACCURACY STUDY; DISEASE COURSE; DRUG EFFICACY; ENZYME LINKED IMMUNOSORBENT ASSAY; FALSE POSITIVE RESULT; FOLLOW UP; HUMAN; IMMUNE RESPONSE; MAJOR CLINICAL STUDY; PHASE 3 CLINICAL TRIAL; PREDICTIVE VALUE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; SCHOOL CHILD; SENSITIVITY AND SPECIFICITY; SEROLOGY; SEROTYPE; THAILAND; VACCINATION; WORLD HEALTH ORGANIZATION; BLOOD; CLINICAL TRIAL; IMMUNOLOGY; PHASE 2 CLINICAL TRIAL; PRESCHOOL CHILD; STATISTICAL BIAS;

ANTIBODIES, VIRAL; BIAS (EPIDEMIOLOGY); CHILD; CHILD, PRESCHOOL; DENGUE; DENGUE VACCINES; ENZYME-LINKED IMMUNOSORBENT ASSAY; FALSE POSITIVE REACTIONS; HUMANS; IMMUNOGLOBULIN G; IMMUNOGLOBULIN M; SENSITIVITY AND SPECIFICITY; SEROLOGIC TESTS; THAILAND; VIRAL NONSTRUCTURAL PROTEINS;

EID: 84963936272     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2016.04.028     Document Type: Article

References (19)

1. Bhatt S., Gething P.W., Brady O.J., Messina J.P., Farlow A.W., Moyes C.L., et al. The global distribution and burden of dengue. Nature 2013, 496:504-507.
2. World Health Organization Dengue haemorrhagic fever: diagnosis, treatment, prevention and control 1997, World Health Organization, Geneva, Available from: http://www.who.int/csr/resources/publications/dengue/Denguepublication/en/ [accessed 24.03.15]. 2nd ed.
3. World Health Organization Dengue guidelines for diagnosis, treatment, prevention and control 2009, World Health Organization, Geneva, Available from: http://www.who.int/tdr/publications/documents/dengue-diagnosis.pdf [accessed 01.04.15]. 3rd ed.
4. Peeling R.W., Artsob H., Pelegrino J.L., Buchy P., Cardosa M.J., Devi S., et al. Evaluation of diagnostic tests: dengue. Nat Rev Microbiol 2010, 8:S30-S38.
5. Centers for Disease Control and Prevention Dengue Branch Laboratory guidance and diagnostic testing 2012, Available from: http://www.cdc.gov/dengue/clinicalLab/laboratory.html [accessed 06.05.15].
6. Houghton-Trivino N., Montana D., Castellanos J. Dengue-yellow fever sera cross-reactivity; challenges for diagnosis. Rev Saude Publica 2008, 10:299-307.
7. Makino Y., Tadano M., Saito M., Maneekarn N., Sittisombut N., Sirisanthana V., et al. Studies on serological cross-reaction in sequential flavivirus infections. Microbiol Immunol 1994, 38:951-955.
8. Hunsperger E., Beltran M., Acosta L.N., Jordan-Munoz J., Torres J., Luce R., et al. Serological evaluation of suspected West Nile virus human cases following its introduction during a dengue outbreak in Puerto Rico in 2007. Clin Vaccine Immunol 2011, 18:978-983.
9. Kumarasamy V., Wahab A.H., Chua S.K., Hassan Z., Chem Y.K., Mohamad M., et al. Evaluation of a commercial dengue NS1 antigen-capture ELISA for laboratory diagnosis of acute dengue virus infection. J Virol Methods 2007, 140:75-79.
10. Hermann L.L., Thaisomboonsuk B., Poolpanichupatam Y., Jarman R.G., Kalayanarooj S., Nisalak A., et al. Evaluation of a dengue NS1 antigen detection assay sensitivity and specificity for the diagnosis of acute dengue virus infection. PLoS Negl Trop Dis 2014, 8:e3193.
11. Wang S.M., Sekaran S.D. Evaluation of a commercial SD dengue virus NS1 antigen capture enzyme-linked immunosorbent assay kit for early diagnosis of dengue virus infection. J Clin Microbiol 2010, 48:2793-2797.
12. Torresi J., Tapia-Conyer R., Margolis H. Preparing for dengue vaccine introduction: recommendations from the 1st dengue v2V International Meeting. PLoS Negl Trop Dis 2013, 7:e2261.
13. World Health Organization WHO expert committee on biological standardization. Fifty-fifth report. WHO Technical Report Series 932 2005, Available from: http://whqlibdoc.who.int/trs/WHO_TRS_932_eng.pdf [accessed 24.03.15].
14. Sabchareon A., Wallace D., Sirivichayakul C., Limkittikul K., Chanthavanich P., Suvannadabba S., et al. Protective efficacy of the recombinant, live-attenuated, CYD tetravalent dengue vaccine in Thai schoolchildren: a randomised, controlled phase 2b trial. Lancet 2012, 380:1559-1567.
15. Prince H.E., Matud J.L. Estimation of dengue virus IgM persistence using regression analysis. Clin Vaccine Immunol 2011, 18:2183-2185.
16. Gubler D.J. Dengue and dengue hemorrhagic fever. Clin Microbiol Rev 1998, 11:480-496.
17. Roth A., Mercier A., Lepers C., Hoy D., Duituturaga S., Benyon E., et al. Concurrent outbreaks of dengue, chikungunya and Zika virus infections - an unprecedented epidemic wave of mosquito-borne viruses in the Pacific 2012-2014. Euro Surveill 2014, 19. pii 20929.
18. Campos G.S., Bandeira A.C., Sardi S.I. Zika virus outbreak, Bahia, Brazil. Emerg Infect Dis 2015, 21:1885-1886.
19. Musso D., Cao-Lormeau V.M., Gubler D.J. Zika virus: following the path of dengue and chikungunya?. Lancet 2015, 386:243-244.