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2. Long-term efficacy and safety of a tetravalent dengue vaccine (TAK-003): 4·5-year results from a phase 3, randomised, double-blind, placebo-controlled trial

Author

Tricou, Vianney, Yu, Delia, Reynales, Humberto, Biswal, Shibadas, Saez-Llorens, Xavier, Sirivichayakul, Chukiat, Lopez, Pio, Borja-Tabora, Charissa, Bravo, Lulu, Kosalaraksa, Pope, Vargas, Luis Martinez, Alera, Maria Theresa, Rivera, Luis, Watanaveeradej, Veerachai, Dietze, Reynaldo, Fernando, LakKumar, Wickramasinghe, V Pujitha, Moreira, Edson Duarte, Jr, Fernando, Asvini D, Gunasekera, Dulanie, Luz, Kleber, Oliveira, Ana Lucia, Tuboi, Suely, Escudero, Ian, Hutagalung, Yanee, Lloyd, Eric, Rauscher, Martina, Zent, Olaf, Folschweiller, Nicolas, LeFevre, Inge, Espinoza, Felix, and Wallace, Derek

Published
2024
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8. 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

Author

Sáez-Llorens, Xavier, Tricou, Vianney, Yu, Delia, Rivera, Luis, Jimeno, José, Villarreal, Ana Cecilia, Dato, Epiphany, Mazara, Sonia, Vargas, Maria, Brose, Manja, Rauscher, Martina, Tuboi, Suely, Borkowski, Astrid, and Wallace, Derek

Published
2018
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9. Dengue diagnostics and therapeutic interventions in Viet Nam

Author

Tricou, Vianney M., Simmons, Cameron P., and Farrar, Jeremy J.

Subjects
616.91852061, Medical Sciences, Infectious diseases, Tropical medicine, Viruses, neglected tropical diseases, virology, dengue, clinical trial, diagnostic, antiviral agents, point-of-care systems, Viet Nam
Abstract

Dengue is a major public health problem that affects tens of millions of people annually in tropical and sub-tropical countries. This acute viral infection happens to be severe and even life threatening but there is still no available drug or vaccine. Previous studies have noted early higher viral burden in patients who develop more severe symptoms suggesting that administration of a potent and safe antiviral may prevent progression to severe dengue. To verify this hypothesis, we have conducted the first RCT directed towards reducing the viral burden in vivo by administrating chloroquine (CQ), a cheap and well-tolerated drug that inhibits DENV in vitro with concentrations achievable in vivo, to 307 Vietnamese adults with suspected dengue (257 of them were laboratory-confirmed cases). Unfortunately, we did not see an effect of CQ on the duration of infection. However in patients treated with CQ, we observed a trend towards a lower incidence of severe forms. We did not find any differences in the immune response that can explain this trend. We also found more adverse events, primarily vomiting, with CQ. In addition, we have explored the relationships between clinical features, antibody responses and virological markers in these patients. We found that the early magnitude of viremia is positively associated with disease severity and there are serotype dependent differences in infection kinetics. We found as well that DENV was cleared faster and earlier in patients with secondary infections. To complete this study, we have also evaluated 2 rapid lateral flow tests for the diagnosis of dengue in a panel of plasma samples from 245 RT-PCR confirmed dengue patients and 47 with other febrile illnesses. Our data suggest that the NS1 test component of these tests are highly specific and have similar levels of sensitivity (~60%). Both NS1 assays were significantly more sensitive for primary than secondary dengue. The IgM parameter in the SD Duo test improved overall test sensitivity without compromising specificity. All these findings are of major importance for further anti-viral drug testing.

Published
2011

10. Analysis of T Cell Immunity Generated by Takeda’s Tetravalent Dengue Vaccine

Author

Omidi, Nazanin, primary, Victor, Kaitlin, additional, Gray, Lauren, additional, Nadeem, Iqra, additional, Bolton, Jessica, additional, Robinson, Tanisha, additional, Hatch, Kristin, additional, Sharma, Mayuri, additional, Mandaric, Sanja, additional, Tricou, Vianney, additional, Currier, Jeffrey, additional, and Friberg, Heather, additional

Published
2023
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13. Immunogenicity and safety of concomitant and sequential administration of yellow fever YF-17D vaccine and tetravalent dengue vaccine candidate TAK-003: A phase 3 randomized, controlled study

Author

Tricou, Vianney, primary, Essink, Brandon, additional, Ervin, John E., additional, Turner, Mark, additional, Escudero, Ian, additional, Rauscher, Martina, additional, Brose, Manja, additional, Lefevre, Inge, additional, Borkowski, Astrid, additional, and Wallace, Derek, additional

Published
2023
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16. Antibodies Produced in Response to a Live-Attenuated Dengue Vaccine are Functional in Activating the Complement System.

Author

Nascimento, Eduardo J M, Norwood, Brooke, Kpamegan, Eloi, Parker, Allan, Fernandes, Jesuina, Perez-Guzman, Erick, Tricou, Vianney, Braun, Ralph, Sharma, Mayuri, and Dean, Hansi J

Subjects
ANTIBODY formation, COMPLEMENT activation, CLINICAL trial registries, DENGUE, PHAGOCYTOSIS, HERPES zoster vaccines, TITERS
Abstract

Background: Antibody-driven complement system (CS) activation has been associated with protection against symptomatic dengue virus (DENV) infection. Aggregation, opsonization, lysis, and phagocytosis are mechanisms triggered by antibody-antigen immunocomplexes following fixation of the component 1q (C1q) and activation of the classical pathway. As a result, DENV neutralization and clearance are facilitated, whereas antibody-dependent enhancement of infection is inhibited. We investigated the ability of antibodies produced in response to Takeda's dengue vaccine candidate, TAK-003, to fix C1q and activate CS.Methods: Serum samples were collected from seronegative and seropositive participants in a phase 2 clinical trial (DEN-203; ClinicalTrials.gov: NCT01511250), pre- and post-vaccination. Samples were evaluated for the presence of complement-fixing antibodies (CFAs) against DENV using a Luminex multiplex-based immunoassay.Results: TAK-003 elicited production of CFAs against all 4 DENV serotypes, which persisted for 1 year post-vaccination, irrespective of baseline serostatus. CFA levels were correlated with neutralizing antibody titers and virus-binding total IgG and IgG1 concentrations. Furthermore, efficiency of CFA fixation was greater in samples with higher polyclonal IgG avidity.Conclusion: These results indicate that antibodies produced after TAK-003 vaccination are functional in both activating CS and neutralizing virus infection by all DENV serotypes, which may contribute to efficacy of TAK-003. [ABSTRACT FROM AUTHOR]

Published
2023
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17. Characterization of the cell-mediated immune response to Takeda’s live-attenuated tetravalent dengue vaccine in adolescents participating in a phase 2 randomized controlled trial conducted in a dengue-endemic setting

Author

Tricou, Vianney, primary, Gottardo, Raphael, additional, Egan, Michael A., additional, Clement, Frédéric, additional, Leroux-Roels, Geert, additional, Sáez-Llorens, Xavier, additional, Borkowski, Astrid, additional, Wallace, Derek, additional, and Dean, Hansi J., additional

Published
2022
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19. Three-year Efficacy and Safety of Takeda’s Dengue Vaccine Candidate (TAK-003)

Author

Rivera, Luis, primary, Biswal, Shibadas, additional, Sáez-Llorens, Xavier, additional, Reynales, Humberto, additional, López-Medina, Eduardo, additional, Borja-Tabora, Charissa, additional, Bravo, Lulu, additional, Sirivichayakul, Chukiat, additional, Kosalaraksa, Pope, additional, Martinez Vargas, Luis, additional, Yu, Delia, additional, Watanaveeradej, Veerachai, additional, Espinoza, Felix, additional, Dietze, Reynaldo, additional, Fernando, LakKumar, additional, Wickramasinghe, Pujitha, additional, Duarte MoreiraJr, Edson, additional, Fernando, Asvini D, additional, Gunasekera, Dulanie, additional, Luz, Kleber, additional, Venâncioda Cunha, Rivaldo, additional, Rauscher, Martina, additional, Zent, Olaf, additional, Liu, Mengya, additional, Hoffman, Elaine, additional, LeFevre, Inge, additional, Tricou, Vianney, additional, Wallace, Derek, additional, Alera, MariaTheresa, additional, and Borkowski, Astrid, additional

Published
2021
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21. Efficacy of a Dengue Vaccine Candidate (TAK-003) in Healthy Children and Adolescents 2 Years after Vaccination

Author

López-Medina, Eduardo, primary, Biswal, Shibadas, additional, Saez-Llorens, Xavier, additional, Borja-Tabora, Charissa, additional, Bravo, Lulu, additional, Sirivichayakul, Chukiat, additional, Vargas, Luis Martinez, additional, Alera, Maria Theresa, additional, Velásquez, Hector, additional, Reynales, Humberto, additional, Rivera, Luis, additional, Watanaveeradej, Veerachai, additional, Rodriguez-Arenales, Edith Johana, additional, Yu, Delia, additional, Espinoza, Felix, additional, Dietze, Reynaldo, additional, Fernando, Lak Kumar, additional, Wickramasinghe, Pujitha, additional, Duarte Moreira, Edson, additional, Fernando, Asvini D, additional, Gunasekera, Dulanie, additional, Luz, Kleber, additional, da Cunha, Rivaldo Venâncio, additional, Tricou, Vianney, additional, Rauscher, Martina, additional, Liu, Mengya, additional, LeFevre, Inge, additional, Wallace, Derek, additional, Kosalaraksa, Pope, additional, and Borkowski, Astrid, additional

Published
2020
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23. Safety and immunogenicity of a tetravalent dengue vaccine in children aged 2–17 years: a randomised, placebo-controlled, phase 2 trial

Author

Tricou, Vianney, primary, Sáez-Llorens, Xavier, additional, Yu, Delia, additional, Rivera, Luis, additional, Jimeno, José, additional, Villarreal, Ana Cecilia, additional, Dato, Epiphany, additional, Saldaña de Suman, Onix, additional, Montenegro, Nathali, additional, DeAntonio, Rodrigo, additional, Mazara, Sonia, additional, Vargas, Maria, additional, Mendoza, Debbie, additional, Rauscher, Martina, additional, Brose, Manja, additional, Lefevre, Inge, additional, Tuboi, Suely, additional, Borkowski, Astrid, additional, and Wallace, Derek, additional

Published
2020
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24. Efficacy of a tetravalent dengue vaccine in healthy children aged 4–16 years: a randomised, placebo-controlled, phase 3 trial

Author

Biswal, Shibadas, primary, Borja-Tabora, Charissa, additional, Martinez Vargas, Luis, additional, Velásquez, Hector, additional, Theresa Alera, Maria, additional, Sierra, Victor, additional, Johana Rodriguez-Arenales, Edith, additional, Yu, Delia, additional, Wickramasinghe, V Pujitha, additional, Duarte Moreira, Edson, additional, Fernando, Asvini D, additional, Gunasekera, Dulanie, additional, Kosalaraksa, Pope, additional, Espinoza, Felix, additional, López-Medina, Eduardo, additional, Bravo, Lulu, additional, Tuboi, Suely, additional, Hutagalung, Yanee, additional, Garbes, Pedro, additional, Escudero, Ian, additional, Rauscher, Martina, additional, Bizjajeva, Svetlana, additional, LeFevre, Inge, additional, Borkowski, Astrid, additional, Saez-Llorens, Xavier, additional, Wallace, Derek, additional, Concepción, Alys, additional, Villarreal, Ana Cecilia, additional, Fernando, Asvini, additional, Sirivichayakul, Chukiat, additional, Rodriguez-Arenales, Edith Johanna, additional, Moreira, Edson Duarte, additional, Reynales, Humberto, additional, Luz, Kleber, additional, Jimeno, Jose, additional, Fernando, LakKumar, additional, Vargas, Luis Martinez, additional, Rivera, Luis, additional, Alera, Maria Theresa, additional, Manacharoen, Onanong, additional, Lopez, Pio, additional, Wickramasinghe, V. Pujitha, additional, Dietze, Reynaldo, additional, da Cunha, Rivaldo Venâncio, additional, Watanaveeradej, Veerachai, additional, Biswal, Shibadas, additional, Brose, Manja, additional, Moss, Kelley, additional, Meyer, Seetha, additional, and Tricou, Vianney, additional

Published
2020
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25. Immunogenicity and safety of lyophilized and liquid dengue tetravalent vaccine candidate formulations in healthy adults: a randomized, phase 2 clinical trial

Author

Turner, Mark, primary, Papadimitriou, Athanasia, additional, Winkle, Peter, additional, Segall, Nathan, additional, Levin, Michael, additional, Doust, Matthew, additional, Johnson, Casey, additional, Lucksinger, Gregg, additional, Fierro, Carlos, additional, Pickrell, Paul, additional, Raanan, Marsha, additional, Tricou, Vianney, additional, Borkowski, Astrid, additional, and Wallace, Derek, additional

Published
2020
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26. Safety and immunogenicity of a single dose of a tetravalent dengue vaccine with two different serotype-2 potencies in adults in Singapore: A phase 2, double-blind, randomised, controlled trial

Author

Tricou, Vianney, primary, Low, Jenny G., additional, Oh, Helen M., additional, Leo, Yee-Sin, additional, Kalimuddin, Shirin, additional, Wijaya, Limin, additional, Pang, Junxiong, additional, Ling, Li Min, additional, Lee, Tau Hong, additional, Brose, Manja, additional, Hutagalung, Yanee, additional, Rauscher, Martina, additional, Borkowski, Astrid, additional, and Wallace, Derek, additional

Published
2020
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28. Imported hepatitis E virus, Central African Republic, 2011

Author

Bouscaillou, Julie, Komas, Narcisse, Tricou, Vianney, Nakoune, Emmanuel, Selekon, Benjamin, Fontanet, Arnaud, and Kazanji, Mirdad

Subjects
Hepatitis E virus -- Identification and classification -- Health aspects -- Genetic aspects -- Research, Disease transmission -- Health aspects -- Research, Polymerase chain reaction -- Usage, Health
Abstract

To the Editor: Hepatitis E virus (HEV) is endemic to India (1,2) and Central African Republic (3,4), although different strains circulate in the countries. In May 2011, a case of [...]

Published
2013

29. Comparison of two dengue NS1 rapid tests for sensitivity, specificity and relationship to viraemia and antibody responses

Author

Farrar Jeremy, Tran Hien T, Nguyen Chau VV, Quynh Nhu VN, Vu Hang TT, Tricou Vianney, Wills Bridget, and Simmons Cameron P

Subjects
Infectious and parasitic diseases, RC109-216
Abstract

Abstract Background Dengue is a major public health problem in tropical and subtropical countries. Rapid and easy diagnosis of dengue can assist patient triage and care-management. The detection of DENV NS1 on rapid lateral flow tests offers a fast route to a presumptive dengue diagnosis but careful evaluations are urgently needed as more and more people use them. Methods The sensitivity and specificity of the Bio-Rad NS1 Ag Strip and SD Dengue Duo (NS1/IgM/IgG) lateral flow rapid tests were evaluated in a panel of plasma samples from 245 Vietnamese patients with RT-PCR confirmed dengue and 47 with other febrile illnesses. Results The NS1 rapid tests had similar diagnostic sensitivities (respectively 61.6% and 62.4%) in confirmed dengue cases but were 100% specific. When IgM/IgG results from the SD Dengue Duo were included in the test interpretation, the sensitivity improved significantly from 62.4% with NS1 alone to 75.5% when NS1 and/or IgM was positive and 83.7% when NS1 and/or IgM and/or IgG was positive. Both NS1 assays were significantly more sensitive for primary than secondary dengue. NS1 positivity was associated with the underlying viraemia as NS1-positive samples had a significantly higher viraemia than NS1-negative samples. Conclusions These data suggest that the NS1 test component of these assays are highly specific and have similar levels of sensitivity. The IgM parameter in the SD Duo test improved overall test sensitivity without compromising specificity. The SD Dengue Duo lateral flow rapid test deserves further prospective evaluation in dengue endemic settings.

Published
2010
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30. Fatal Outcome in a Hepatitis E Virus/Human Immunodeficiency Virus Co-Infected Malnourished Child in the Central African Republic.

Author

Tabounie, Stéphanie Judith N'Yetobouko, Kango, Simplice Cyriaque, Bouscaillou, Julie, Tricou, Vianney, Fontanet, Arnaud, Kazanji, Mirdad, and Komas, Narcisse Patrice

Subjects
HEPATITIS E virus, HIV, ALANINE aminotransferase, IMMUNOGLOBULIN G, MEDICAL needs assessment
Abstract

Hepatitis E virus (HEV) infection is responsible for major endemic outbreaks in developing countries. Human immunodeficiency virus (HIV) and HEV are widespread in the Central African Republic. We report the first documented case of an HEV infection in a 36-month-old child already suffering from HIV and severe acute malnutrition (SAM). The HIV patient was hospitalized for SAM with persistent diarrhea and prolonged fever. The presence of IgG anti-HEV antibodies was noted. Sequencing of the amplified HEV RNA revealed the presence of genotype 3c. The alanine aminotransferase level was slightly above average. The patient died despite being treated by antiretroviral therapy accompanied by probabilistic antibiotic therapy and nutritional rehabilitation. HEV/HIV co-infection in a malnourished patient can accelerate a fatal outcome. In the presence of biological abnormalities in a severe acutely malnourished HIV-infected patient, HEV RNA detection should be added to the standard medical assessment in sub-Saharan African countries. [ABSTRACT FROM AUTHOR]

Published
2020
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34. Etiology and Epidemiology of Diarrhea in Hospitalized Children from Low Income Country: A Matched Case-Control Study in Central African Republic

Author

Breurec, Sébastien, primary, Vanel, Noémie, additional, Bata, Petulla, additional, Chartier, Loïc, additional, Farra, Alain, additional, Favennec, Loïc, additional, Franck, Thierry, additional, Giles-Vernick, Tamara, additional, Gody, Jean-Chrysostome, additional, Luong Nguyen, Liem Binh, additional, Onambélé, Manuella, additional, Rafaï, Clotaire, additional, Razakandrainibe, Romy, additional, Tondeur, Laura, additional, Tricou, Vianney, additional, Sansonetti, Philippe, additional, and Vray, Muriel, additional

Published
2016
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36. Molecular surveillance of rotavirus infection in Bangui, Central African Republic, October 2011–September 2013

Author

Banga-Mingo, Virginie, primary, Waku-Kouomou, Diane, additional, Gody, Jean Chrysostome, additional, Esona, Mathew D., additional, Yetimbi, Jean Fandema, additional, Mbary-Daba, Regis, additional, Dahl, Benjamin A., additional, Dimanche, Leon, additional, Koyazegbe, Thomas d’Aquin, additional, Tricou, Vianney, additional, Cavallaro, Kathleen F., additional, Guifara, Gilbert, additional, Bowen, Michael D., additional, and Gouandjika-Vasilache, Ionela, additional

Published
2014
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43. High-Resolution Analysis of Intrahost Genetic Diversity in Dengue Virus Serotype 1 Infection Identifies Mixed Infections

Author

Thai, Khoa T. D., primary, Henn, Matthew R., additional, Zody, Michael C., additional, Tricou, Vianney, additional, Nguyet, Nguyen Minh, additional, Charlebois, Patrick, additional, Lennon, Niall J., additional, Green, Lisa, additional, de Vries, Peter J., additional, Hien, Tran Tinh, additional, Farrar, Jeremy, additional, van Doorn, H. Rogier, additional, de Jong, Menno D., additional, Birren, Bruce W., additional, Holmes, Edward C., additional, and Simmons, Cameron P., additional

Published
2012
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47. Diagnostic Accuracy of NS1 ELISA and Lateral Flow Rapid Tests for Dengue Sensitivity, Specificity and Relationship to Viraemia and Antibody Responses

Author

Ty Hang, Vu, primary, Minh Nguyet, Nguyen, additional, The Trung, Dinh, additional, Tricou, Vianney, additional, Yoksan, Sutee, additional, Minh Dung, Nguyen, additional, Van Ngoc, Tran, additional, Hien, Tran Tinh, additional, Farrar, Jeremy, additional, Wills, Bridget, additional, and Simmons, Cameron P., additional

Published
2009
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48. Comparison of two dengue NS1 rapid tests forsensitivity, specificity and relationship to viraemiaand antibody responses.

Author

Tricou, Vianney, Vu, Hang T. T., Quynh, Nhu V. N., Nguyen, Chau V. V., Tran, Hien T., Farrar, Jeremy, Wills, Bridget, and Simmons, Cameron P.

Subjects
*DENGUE, *PUBLIC health, *HEALTH services administration, *IMMUNOGLOBULIN M, *DIAGNOSIS
Abstract

Background: Dengue is a major public health problem in tropical and subtropical countries. Rapid and easy diagnosis of dengue can assist patient triage and care-management. The detection of DENV NS1 on rapid lateral flow tests offers a fast route to a presumptive dengue diagnosis but careful evaluations are urgently needed as more and more people use them. Methods: The sensitivity and specificity of the Bio-Rad NS1 Ag Strip and SD Dengue Duo (NS1/IgM/IgG) lateral flow rapid tests were evaluated in a panel of plasma samples from 245 Vietnamese patients with RT-PCR confirmed dengue and 47 with other febrile illnesses. Results: The NS1 rapid tests had similar diagnostic sensitivities (respectively 61.6% and 62.4%) in confirmed dengue cases but were 100% specific. When IgM/IgG results from the SD Dengue Duo were included in the test interpretation, the sensitivity improved significantly from 62.4% with NS1 alone to 75.5% when NS1 and/or IgM was positive and 83.7% when NS1 and/or IgM and/or IgG was positive. Both NS1 assays were significantly more sensitive for primary than secondary dengue. NS1 positivity was associated with the underlying viraemia as NS1-positive samples had a significantly higher viraemia than NS1-negative samples. Conclusions: These data suggest that the NS1 test component of these assays are highly specific and have similar levels of sensitivity. The IgM parameter in the SD Duo test improved overall test sensitivity without compromising specificity. The SD Dengue Duo lateral flow rapid test deserves further prospective evaluation in dengue endemic settings. [ABSTRACT FROM AUTHOR]

Published
2010
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49. Tetravalent Dengue Vaccine in Healthy Children.

Author

Salvana, Edsel M., Swaminathan, Sathyamangalam, Khanna, Navin, Biswal, Shibadas, Tricou, Vianney, and Dean, Hansi

Subjects
*DENGUE hemorrhagic fever, *DENGUE, *VACCINES, *HEMORRHAGIC fever, *KILLER cells, *FLAVIVIRUSES, *VIRAL vaccines
Published
2020
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50. Immunogenicity, safety, and efficacy of a tetravalent dengue vaccine in children and adolescents: an analysis by age group.

Author

Borja-Tabora C, Fernando L, Lopez Medina E, Reynales H, Rivera L, Saez-Llorens X, Sirivichayakul C, Yu D, Folschweiller N, Moss KJ, Rauscher M, Tricou V, Zhao Y, and Biswal S

Abstract

Background: Dengue is an increasing threat to global health. This exploratory analysis evaluated the immunogenicity, safety, and vaccine efficacy (VE) of a live-attenuated tetravalent dengue vaccine (TAK-003) in participants enrolled in the phase 3 DEN-301 trial (NCT02747927), stratified by baseline age (4-5 years; 6-11 years; or 12-16 years)., Methods: Participants were randomized 2:1 to receive 2 doses of TAK-003, administered 3 months apart, or placebo. Dengue serostatus was evaluated at enrolment. VE against virologically-confirmed dengue (VCD) and hospitalized VCD; immunogenicity (geometric mean titers; GMTs); and safety were evaluated per age group through ∼4 years post-vaccination., Results: VE against VCD across serotypes was 43.5% (95% confidence interval: 25.3%, 57.3%) for 4-5 year-olds; 63.5% (56.9%, 69.1%) for 6-11 year-olds, and 67.7% (57.8%, 75.2%) for 12-16 year-olds. VE against hospitalized VCD was 63.8% (21.1%, 83.4%), 85.1% (77.1%, 90.3%), and 89.7% (77.9%, 95.2%), for the three age groups, respectively. GMTs remained elevated against all four serotypes for ∼4 years post-vaccination, with no evident differences across age groups. No clear differences in safety by age were identified., Conclusions: This exploratory analysis shows TAK-003 was efficacious in dengue prevention across age groups in children and adolescents 4-16 years of age living in dengue endemic areas. Relatively lower VE in 4-5 year-olds was potentially confounded by causative serotype distribution, small sample size, and VE by serotype, and should be considered in benefit-risk evaluations in this age group., (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Published
2024
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