Evidence map›Paper›PMID 30241510›Full record

Trial reportBMC infectious diseases2018

Immunogenicity of the CYD tetravalent dengue vaccine using an accelerated schedule: randomised phase II study in US adults.

Judith Kirstein, William Douglas, Manoj Thakur, Mark Boaz, Thomas Papa, Anna Skipetrova, Eric Plennevaux

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC infectious diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01488890 (Evaluation of the Immune Response to Different Schedules of a Tetravalent Dengue Vaccine Administered With or Without Yellow Fever Vaccine in US Adults.), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.1field-weighted citation impact, top 19% 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.

NCT01488890 phase2completednot on this map

Evaluation of the Immune Response to Different Schedules of a Tetravalent Dengue Vaccine Administered With or Without Yellow Fever Vaccine in US Adults.

TypeinterventionalSponsorSanofi Pasteur, a Sanofi CompanyRan2011 to 2013Enrolled390ConditionsDengue, Dengue Fever, Dengue Hemorrhagic Fever, Yellow FeverArmsLive, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus, Yellow Fever
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 19 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. Human T Cell Responses to Flavivirus Vaccines.European journal of immunology · 2025
    Review
  6. Article
  7. Review
  8. Article
  9. Review
  10. A review of Dengvaxia®: development to deployment.Human vaccines & immunotherapeutics · 2019
    Review
  11. Article
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

7 authors at 4 institutions in 2 countries.

Judith KirsteinAdvanced Clinical Research, West Jordan, UT, USA.
William DouglasBenchmark Research, Sacramento, CA, USA.
Manoj ThakurSanofi Pasteur, Global Clinical Immunology, Discovery Drive, Swiftwater, PA, 18370, USA.
Mark BoazSanofi Pasteur, Global Clinical Immunology, Discovery Drive, Swiftwater, PA, 18370, USA.
Thomas PapaSanofi Pasteur, Siège Social, 14 Espace Henry Vallée, 69007, Lyon, France.
Anna SkipetrovaSanofi Pasteur, Siège Social, 14 Espace Henry Vallée, 69007, Lyon, France.
Eric PlennevauxSanofi Pasteur, Siège Social, 14 Espace Henry Vallée, 69007, Lyon, France. Eric.Plennevaux@sanofipasteur.com.
Sanofi (France) · FRSanofi (United States) · USAdvanced Pharma · USBenchmark Research (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe live attenuated tetravalent dengue vaccine (CYD-TDV) is licensed using a 0-, 6- and 12-month schedule in dengue-endemic areas. An effective shorter schedule may provide more rapid, optimal protection of targeted populations during vaccine campaigns in dengue-endemic countries. We compared immune responses to two schedules of CYD-TDV in a non-endemic population. We also evaluated the impact of yellow fever (YF) co-administration.

methodsThis phase II, open-label, multicentre study enrolled 390 healthy 18-45-year-olds in the USA with no prior exposure to dengue. Participants were randomised (4:4:4:1) to four treatment groups stratified by prior YF vaccine status: Group 1, CYD-TDV standard 0-6-12 months schedule; Group 2, CYD-TDV accelerated 0-2-6 months schedule; Group 3, CYD-TDV accelerated schedule with YF co-administered (dose 1); Group 4, YF vaccination only. Neutralising antibody geometric mean titres (GMTs) and percentages of seropositive participants (antibody titres ≥10 [1/dil]) were measured against each dengue serotype using a 50% plaque reduction neutralisation test.

resultsOn D28 post-CYD-TDV dose 3, there were no marked differences in seropositivity rates and GMTs between Groups 1 and 2. In Groups 1 and 2 respectively, 73.4 and 82.4% were dengue seropositive for ≥3 serotypes, with 50.0 and 42.6% seropositive against all four serotypes. Flavivirus status (FV+ or FV-) at baseline did not markedly affect GMTs and seropositivity rates with either schedule. In Groups 1 and 2, GMTs measured 6 months after the third dose decreased against all serotypes, except for a small increase in GMT for serotype 4 in Group 1. In addition, dengue seropositivity remained above 70% for serotypes 2, 3 and 4 in Groups 1 and 2. Co-administration with YF did not affect antibody responses against dengue and YF or impact vaccine safety following completion of the compressed schedule, compared to dengue or YF vaccination alone.

conclusionsThe live attenuated CYD-TDV vaccine given in a compressed schedule in a non-endemic setting can elicit similar antibody responses to the licensed CYD-TDV schedule.

trial registrationThis trial was registered on cinicaltrials.gov, NCT01488890 (December 8, 2011).

Indexed as

AdolescentAdultAntibodies, NeutralizingAntibodies, ViralAntigen-Antibody ReactionsDengueDengue VaccinesDengue VirusFemaleHumansKineticsMaleSerogroupUnited StatesVaccines, AttenuatedYellow FeverAntibodies, NeutralizingAntibodies, ViralCYD-TDV vaccineDengue VaccinesVaccines, AttenuatedYellow Fever VaccineDengueLive attenuated tetravalent dengue vaccineVaccination scheduleYellow fever

Identifiers

PMID30241510
PMCPMC6150954
OpenAlexW2889837349

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.