Evidence map›Paper›PMID 25483647›Full record

Trial reportHuman vaccines & immunotherapeutics2014

Assessment of bivalent and tetravalent dengue vaccine formulations in flavivirus-naïve adults in Mexico.

Gustavo H Dayan, Juan-Francisco Galán-Herrera, Remi Forrat, Betzana Zambrano, Alain Bouckenooghe, Anke Harenberg, Bruno Guy, Jean Lang

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00740155 (Safety and Immunogenicity of Bivalent and Tetravalent Formulations of Dengue Vaccine Candidates in Healthy Flavivirus-Naïve Adults Aged 18 to 45 Years), which is not on this map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
4.8field-weighted citation impact, top 5% 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.

NCT00740155 phase2completednot on this map

Safety and Immunogenicity of Bivalent and Tetravalent Formulations of Dengue Vaccine Candidates in Healthy Flavivirus-Naïve Adults Aged 18 to 45 Years

TypeinterventionalSponsorSanofi Pasteur, a Sanofi CompanyRan2008 to 2010Enrolled154ConditionsDengue Virus, Dengue Fever, Dengue Hemorrhagic Fever, Dengue DiseasesArmsBivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero), Tetravalent blending VDV-2/CYD-1,3,4 Dengue (Vero), Tetravalent CYD-1,2,3,4 Dengue (Vero), JE-VAX®: Japanese encephalitis virus vaccine inactivated + Tetravalent CYD-1,2,3,4 Dengue (Vero)
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 33 citations in OpenAlex.

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  15. A review of Dengvaxia®: development to deployment.Human vaccines & immunotherapeutics · 2019
    Review
  16. Review
  17. Review
  18. Prevention and Control Strategies to Counter Dengue Virus Infection.Frontiers in cellular and infection microbiology · 2017
    Review
  19. Article
  20. Review
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

8 authors at 2 institutions in 4 countries.

Gustavo H Dayana Research and Development Department ; Sanofi Pasteur ; Swiftwater , PA USA.
Juan-Francisco Galán-Herrera
Remi Forrat
Betzana Zambrano
Alain Bouckenooghe
Anke Harenberg
Bruno Guy
Jean Lang
Sanofi (Mexico) · MXSanofi (France) · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

unlabelledSeveral ChimeriVax-Dengue (CYD)-based vaccination strategies were investigated as potential alternatives to vaccination with tetravalent CYD vaccine (CYD-TDV) in this phase IIa trial conducted in 2008-9 in 150 healthy adults. Participants were randomized and vaccinated on D0 and D105 (± 15 days). One group received bivalent CYD vaccine against serotypes 1 and 3 (CYD-1;3) on day 0 and CYD-2;4 on day 105 (± 15 days). Two groups received an injection at each timepoint of a tetravalent blend of CYD-1;3;4 and a VERO cell derived, live attenuated vaccine against serotype 2 (VDV-2), or the reference CYD-TDV. A fourth group received Japanese encephalitis (JE) vaccine on days -14, -7 and 0, followed by CYD-TDV on day 105. Viraemia was infrequent in all groups. CYD-4 viraemia was most frequent after tetravalent vaccination, while CYD-3 viraemia was most frequent after the first bivalent vaccination. Immunogenicity as assessed by 50% plaque reduction neutralisation test on D28 was comparable after the first injection of either tetravalent vaccine, and increased after the second injection, particularly with the blended CYD-1;3;4/ VDV-2 vaccine. In the bivalent vaccine group, immune response against serotype 3 was highest and the second injection elicited a low immune response against CYD 2 and 4. Immune responses after the first injection of CYD-TDV in the JE-primed group were in general higher than after the first injection in the other groups. All tested regimens were well tolerated without marked differences between groups. Bivalent vaccination showed no advantage in terms of immunogenicity. CLINICAL TRIAL REGISTRATION NUMBER: NCT00740155.

Indexed as

AdolescentAdultAntibodies, NeutralizingAntibodies, ViralDengueDengue VaccinesDengue VirusFemaleHumansImmunity, CellularImmunity, HumoralJapanese Encephalitis VaccinesMaleMexicoNeutralization TestsVaccinationAntibodies, NeutralizingAntibodies, ViralChimeriVaxDengue VaccinesJapanese Encephalitis VaccinesVaccines, AttenuatedWest Nile Virus VaccinesADE, antibody-dependent enhancementAE, adverse eventALT, aspartate aminotransferaseAST, alanine aminotransferaseCBA, cytometric bead arrayCI, confidence intervalCPK, creatine phosphokinaseCYD-TDV, CYD tetravalent dengue vaccinedengueflavivirusGMT, geometric mean titresICS, intracellular cytokine stainingIFN, interferonimmunogenicityJapanese encephalitisJE, Japanese encephalitisLLOQ, lower limit of quantitationMedDRA, medical dictionary for regulatory activitiesMOI, multiplicity of infectionPBMC, peripheral blood mononuclear cellsPFU, plaque forming unitPRNT, plaque reduction neutralization testRT-PCR, reverse transcriptase-polymerase chain reactionsafetyTCID, tissue culture infectious dosevaccineVDV, vero-cell adapted attenuated dengue vaccineYF, yellow fever

Identifiers

PMID25483647
PMCPMC5443102
OpenAlexW1991673588

What OpenQuestion holds

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LicenceCC BY-NC
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.