Evidence map›Paper›PMID 32124728›Full record

Trial reportThe American journal of tropical medicine and hygiene2020

Safety and Immunogenicity of Different Formulations of a Tetravalent Dengue Purified Inactivated Vaccine in Healthy Adults from Puerto Rico: Final Results after 3 Years of Follow-Up from a Randomized, Placebo-Controlled Phase I Study.

Clemente Diaz, Michael Koren, Leyi Lin, Luis J Martinez, Kenneth H Eckels, Maribel Campos, Richard G Jarman, Rafael De La Barrera, Edith Lepine, Irma Febo and 5 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in The American journal of tropical medicine and hygiene, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01702857 (A Phase I, Randomized, Placebo-Controlled, Observer-blind, Two-dose), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.6field-weighted citation impact, top 16% 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.

NCT01702857 phase1completednot on this map

A Phase I, Randomized, Placebo-Controlled, Observer-blind, Two-dose (0-28 Day Schedule) Primary Vaccination Study of WRAIR Tetravalent Dengue Virus Purified Inactivated Vaccine (TDENV-PIV) in Healthy Adults in Puerto Rico

TypeinterventionalSponsorU.S. Army Medical Research and Development CommandRan2012 to 2017Enrolled100ConditionsDengue FeverArmsBiological/Vaccine: 4 µg TDENV-PIV with Alum adjuvant, Biological/Vaccine: 1 µg TDENV-PIV with AS03B adjuvant, Phosphate buffered saline, 1 µg TDENV-PIV with Alum adjuvant, 1 µg TDENV-PIV with AS01E adjuvant
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 14 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Review
  5. Review
  6. Review
  7. Article
  8. Review
  9. Dengue: Update on Clinically Relevant Therapeutic Strategies and Vaccines.Current treatment options in infectious diseases · 2023
    Review
  10. Review
  11. Article
  12. Review
  13. 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

15 authors at 3 institutions in 2 countries.

Clemente DiazUniversity of Puerto Rico School of Medicine, San Juan, Puerto Rico.
Michael KorenWalter Reed Army Institute of Research, Silver Spring, Maryland.
Leyi LinWalter Reed Army Institute of Research, Silver Spring, Maryland.
Luis J MartinezWalter Reed Army Institute of Research, Silver Spring, Maryland.
Kenneth H EckelsWalter Reed Army Institute of Research, Silver Spring, Maryland.
Maribel CamposUniversity of Puerto Rico School of Medicine, San Juan, Puerto Rico.
Richard G JarmanWalter Reed Army Institute of Research, Silver Spring, Maryland.
Rafael De La BarreraWalter Reed Army Institute of Research, Silver Spring, Maryland.
Edith LepineGSK, Rockville, Maryland.
Irma FeboUniversity of Puerto Rico School of Medicine, San Juan, Puerto Rico.
David W VaughnGSK, Rockville, Maryland.
Todd M WilsonGSK, Rockville, Maryland.
Robert M ParisGSK, Rockville, Maryland.
Alexander C SchmidtGSK, Rockville, Maryland.
Stephen J ThomasWalter Reed Army Institute of Research, Silver Spring, Maryland.
Walter Reed Army Institute of Research · USGlaxoSmithKline (United States) · USUniversity of Puerto Rico System · PR

Funding

University of Puerto Rico Mentoring Institute for HIV Mental Health ResearchR25MH083617 · NIMH · UNIVERSITY OF PUERTO RICO MED SCIENCES · PI ZORRILLA, CARMEN D · 2008 to 2020
$3.7M
NIMH NIH HHS R25 MH083617
6 · The paper itself

Abstract

Four formulations of an investigational tetravalent dengue purified inactivated vaccine, administered as two doses one month (M) apart, were previously shown to be immunogenic and well-tolerated up to M13 of the phase I study NCT01702857. Here, we report results of the follow-up from M14 to year (Y) 3. One hundred healthy Puerto Rican adults, predominantly dengue virus (DENV)-primed, were randomized 1:1:1:1:1 to receive placebo or vaccine formulations: 1 μg/serotype/dose adjuvanted with aluminum, AS01

Indexed as

AdultAntibodies, NeutralizingAntibodies, ViralDengueDengue VaccinesDengue VirusFemaleFollow-Up StudiesHumansMalePuerto RicoAntibodies, NeutralizingAntibodies, ViralDengue Vaccines

Identifiers

PMID32124728
PMCPMC7204593
OpenAlexW3009043885

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.