Evidence map›Paper›PMID 34606595›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2022

Three-year Efficacy and Safety of Takeda's Dengue Vaccine Candidate (TAK-003).

Luis Rivera, Shibadas Biswal, Xavier Sáez-Llorens, Humberto Reynales, Eduardo López-Medina, Charissa Borja-Tabora, Lulu Bravo, Chukiat Sirivichayakul, Pope Kosalaraksa, Luis Martinez Vargas and 20 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 129 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
129citing papers in PubMed, 4 pooled it
30.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

129 citing papers in PubMed, 4 syntheses or guidelines pooled it, 228 citations in OpenAlex.

  1. Pooled it
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  6. Immunogenicity, Safety, and Efficacy of a Tetravalent Dengue Vaccine in Children and Adolescents: An Analysis by Age Group.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
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  14. Clinical Safety Experience of TAK-003 for Dengue Fever: A New Tetravalent Live Attenuated Vaccine Candidate.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
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69 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

30 authors at 19 institutions in 10 countries.

Luis RiveraHospital Maternidad Nuestra Senora de Altagracia, Santo Domingo, Dominican Republic.
Shibadas BiswalTakeda Vaccines, Inc., Boston, Massachusetts, USA.
Xavier Sáez-LlorensHospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at SENACYT, Centro de Vacunación Internacional (Cevaxin), Panama City, Panama.
Humberto ReynalesCentro de Atención e Investigación Médica, CAIMED, Bogotá, Colombia.
Eduardo López-MedinaCentro de Estudios en Infectología Pediátrica, Universidad del Valle and Centro Medico Imbanaco, Cali, Colombia.
Charissa Borja-TaboraResearch Institute For Tropical Medicine, Muntinlupa, Philippines.
Lulu BravoUniversity of the Philippines Manila, Ermita, Philippines.
Chukiat SirivichayakulDepartment of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Pope KosalaraksaFaculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
Luis Martinez VargasCAIMED, Dominicana, Santo Domingo, Dominican Republic.
Delia YuDe La Salle Medical and Health Sciences Institute, Dasmariñas, Philippines.
Veerachai WatanaveeradejPhramongkutklao Hospital, Bangkok, Thailand.
Felix EspinozaNational Autonomous University of Nicaragua, León, Nicaragua.
Reynaldo DietzeNúcleo de Doenças Infecciosas, Centro de Ciencias da Saude-UFES, Vitória, Brazil.
LakKumar FernandoCentre for Clinical Management of Dengue & Dengue Haemorrhagic Fever, Negombo General Hospital, Negombo, Sri Lanka.
Pujitha WickramasingheUniversity of Colombo, Colombo, Sri Lanka.
Edson Duarte MoreiraJrAssociação Obras Sociais Irmã Dulce Hospital Santo Antônio and Oswaldo Cruz Foundation, Bahia, Brazil.
Asvini D FernandoFaculty of Medicine, University of Kelaniya, Colombo, Sri Lanka.
Dulanie GunasekeraFaculty of Medical Sciences, University of Sri Jayawardenenpura, Colombo, Sri Lanka.
Kleber LuzInstituto de Medicina Tropical da Universidade Federal do Rio Grande do Norte, Natal, Brazil.
Rivaldo Venâncioda CunhaUniversidade Federal de Mato Grosso do Sul, Campo Grande, Brazil.
Martina RauscherTakeda Pharmaceuticals International AG, Zurich, Switzerland.
Olaf ZentTakeda Pharmaceuticals International AG, Zurich, Switzerland.
Mengya LiuTakeda Vaccines, Inc., Boston, Massachusetts, USA.
Elaine HoffmanTakeda Vaccines, Inc., Boston, Massachusetts, USA.
Inge LeFevreTakeda Pharmaceuticals International AG, Zurich, Switzerland.
Vianney TricouTakeda Pharmaceuticals International AG, Zurich, Switzerland.
Derek WallaceTakeda Vaccines, Inc., Boston, Massachusetts, USA.
MariaTheresa AleraPhilippines-Armed Forces Research Institute of Medical Sciences Virology Research Unit, Cebu City, Philippines.
Astrid BorkowskiTakeda Pharmaceuticals International AG, Zurich, Switzerland.
Takeda (Switzerland) · CHTakeda (United States) · USArmed Forces Research Institute of Medical Science · THDe La Salle University – Dasmariñas · PHFundação Oswaldo Cruz · BRInstituto Federal do Rio Grande do Norte · BRKhon Kaen University · THMahidol Oxford Tropical Medicine Research Unit · THPhramongkutklao Hospital · THResearch Institute for Tropical Medicine · PHSecretaría Nacional de Ciencia, Tecnología e Innovación · PAUniversidad Autónoma de Santo Domingo · DOUniversidad del Valle · COUniversidade Federal de Mato Grosso do Sul · BRUniversidad Nacional Autónoma de Nicaragua-León · NIUniversity of Colombo · LKUniversity of Kelaniya · LKUniversity of Sri Jayewardenepura · LKUniversity of the Philippines Manila · PH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTakeda's live attenuated tetravalent dengue vaccine candidate (TAK-003) is under evaluation in a long-term clinical trial across 8 dengue-endemic countries. Previously, we have reported its efficacy and safety in both seronegative and seropositive participants and that its performance varies by serotype, with some decline in efficacy from first to second year postvaccination. This exploratory analysis provides an update with cumulative and third-year data.

methodsHealthy 4-16 year olds (n = 20099) were randomized 2:1 to receive TAK-003 or placebo (0, 3 month schedule). The protocol included baseline serostatus testing of all participants and detection of all symptomatic dengue throughout the trial with a serotype specific reverse transcriptase-polymerase chain reaction.

resultsCumulative efficacy after 3 years was 62.0% (95% confidence interval, 56.6-66.7) against virologically confirmed dengue (VCD) and 83.6% (76.8-88.4) against hospitalized VCD. Efficacy was 54.3% (41.9-64.1) against VCD and 77.1% (58.6-87.3) against hospitalized VCD in baseline seronegatives, and 65.0% (58.9-70.1) against VCD and 86.0% (78.4-91.0) against hospitalized VCD in baseline seropositives. Efficacy against VCD during the third year declined to 44.7% (32.5-54.7), whereas efficacy against hospitalized VCD was sustained at 70.8% (49.6-83.0). Rates of serious adverse events were 2.9% in TAK-003 group and 3.5% in placebo group during the ongoing long-term follow-up (ie, second half of the 3 years following vaccination), but none were related. No important safety risks were identified.

conclusionsTAK-003 was efficacious against symptomatic dengue over 3 years. Efficacy declined over time but remained robust against hospitalized dengue. A booster dose evaluation is planned.

Indexed as

DengueDengue VaccinesDengue VirusAntibodies, ViralHumansSerogroupTreatment OutcomeVaccines, AttenuatedVaccines, CombinedAntibodies, ViralDengue VaccinesVaccines, AttenuatedVaccines, Combinedchildrendengueefficacysafetyvaccine

Identifiers

PMID34606595
PMCPMC9402653
OpenAlexW3203455658

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.