Evidence map›Paper›PMID 30427741›Full record

Trial reportHuman vaccines & immunotherapeutics2019

Immunogenicity and safety of an investigational tetravalent recombinant subunit vaccine for dengue: results of a Phase I randomized clinical trial in flavivirus-naïve adults.

Susan B Manoff, Michele Sausser, Amy Falk Russell, Jason Martin, David Radley, Donna Hyatt, Christine C Roberts, Jason Lickliter, Janakan Krishnarajah, Andrew Bett and 3 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01477580 (A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Tetravalent Recombinant Subunit Dengue Vaccine), which is not on this map. Cited by 43 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 1 pooled it
4.6field-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.

NCT01477580 phase1completednot on this map

A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Tetravalent Recombinant Subunit Dengue Vaccine (V180) in Healthy Adults

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2012 to 2014Enrolled98ConditionsDengueArmsLow-dose V180 with low-dose ISCOMATRIX™ adjuvant, Low-dose V180 with medium-dose ISCOMATRIX™ adjuvant, Medium-dose V180 (non-adjuvanted), Medium-dose V180 with low-dose ISCOMATRIX™ adjuvant, Medium-dose V180 with medium-dose ISCOMATRIX™ adjuvant
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 1 synthesis or guideline pooled it, 67 citations in OpenAlex.

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  8. Dengue Vaccines.Current topics in microbiology and immunology · 2026
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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

13 authors at 2 institutions in 2 countries.

Susan B ManoffMerck & Co., Inc , Kenilworth, NJ , USA.
Michele SausserMerck & Co., Inc , Kenilworth, NJ , USA.
Amy Falk RussellMerck & Co., Inc , Kenilworth, NJ , USA.
Jason MartinMerck & Co., Inc , Kenilworth, NJ , USA.
David RadleyMerck & Co., Inc , Kenilworth, NJ , USA.
Donna HyattMerck & Co., Inc , Kenilworth, NJ , USA.
Christine C RobertsMerck & Co., Inc , Kenilworth, NJ , USA.
Jason LickliterNucleus Network LTD , Melbourne , Australia.
Janakan KrishnarajahLinear Clinical Research LTD , Perth , Australia.
Andrew BettMerck & Co., Inc , Kenilworth, NJ , USA.
Sheri DubeyMerck & Co., Inc , Kenilworth, NJ , USA.ORCID 0000-0002-0712-9865
Tyler FinnMerck & Co., Inc , Kenilworth, NJ , USA.
Beth-Ann CollerMerck & Co., Inc , Kenilworth, NJ , USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USLinear Clinical Research · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

There is an unmet medical need for vaccines to prevent dengue. V180 is an investigational recombinant subunit vaccine that consists of truncated dengue envelope proteins (DEN-80E) for all 4 serotypes. Three dosage levels of the tetravalent DEN-80E antigens were assessed in a randomized, placebo-controlled, Phase I dose-escalation, first-in-human proof-of-principle trial in healthy, flavivirus-naïve adults in Australia (NCT01477580). The 9 V180 formulations that were assessed included either ISCOMATRIX™ adjuvant (2 dosage levels), aluminum-hydroxide adjuvant, or were unadjuvanted, and were compared to phosphate-buffered saline placebo. Volunteers received 3 injections of assigned product on a 0, 1, 2 month schedule, and were followed for safety through 1 year after the last injection. Antibody levels were assessed at 6 time-points: enrollment, 28 days after each injection, and 6 and 12 months Postdose 3 (PD3). Of the 98 randomized participants, 90 (92%) received all 3 injections; 83 (85%) completed 1-year follow-up. Immunogenicity was measured by a qualified Focus Reduction Neutralization Test with a 50% neutralization cutoff (FRNT

Indexed as

Immunogenicity, VaccineAdjuvants, ImmunologicAdolescentAdultAntibodies, NeutralizingAntibodies, ViralDengueDengue VaccinesDengue VirusDrug CompoundingFemaleHumansImmunization ScheduleMaleMiddle AgedNeutralization TestsAdjuvants, ImmunologicAntibodies, NeutralizingAntibodies, ViralDengue VaccinesVaccines, SubunitVaccines, Syntheticdengue vaccineimmunogenicityrecombinantsafetysubunit

Identifiers

PMID30427741
PMCPMC6773383
OpenAlexW2901210004

What OpenQuestion holds

Textmetadata
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.