Evidence map›Paper›PMID 37221466›Full record

ArticleBMC infectious diseases2023

Phase 1 trial to model primary, secondary, and tertiary dengue using a monovalent vaccine.

Camila D Odio, Kelsey E Lowman, Melissa Law, Rosemary A Aogo, Sally Hunsberger, Brad J Wood, Michael Kassin, Elliot Levy, Viviane Callier, Saba Firdous and 8 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in BMC infectious diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05691530 (Phase 1 Trial to Model Primary, Secondary, and Tertiary Dengue Using a Monovalent Vaccine), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 31% 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.

NCT05691530 phase1completednot on this map

Phase 1 Trial to Model Primary, Secondary, and Tertiary Dengue Using a Monovalent Vaccine

TypeinterventionalSponsorNational Institutes of Health Clinical Center (CC)Ran2023 to 2025Enrolled127ConditionsResponse To Dengue ExposureArmsrDEN3Δ30/31-7164
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. 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

18 authors at 6 institutions in 2 countries.

Camila D OdioViral Epidemiology and Immunity Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA. camila.odio@nih.gov.
Kelsey E LowmanViral Epidemiology and Immunity Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Melissa LawViral Epidemiology and Immunity Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Rosemary A AogoViral Epidemiology and Immunity Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Sally HunsbergerDivision of Clinical Research, Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Brad J WoodInterventional Radiology and Center for Interventional Oncology, NIH Clinical Center and National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Michael KassinInterventional Radiology and Center for Interventional Oncology, NIH Clinical Center and National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Elliot LevyInterventional Radiology and Center for Interventional Oncology, NIH Clinical Center and National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Viviane CallierClinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, USA.
Saba FirdousViral Epidemiology and Immunity Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Chloe M HasundViral Epidemiology and Immunity Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Charlie VoirinViral Epidemiology and Immunity Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Robbie KattappuramDepartment of Pharmacy, NIH Clinical Center, National Institutes of Health, Bethesda, MD, USA.
Christina YekInternational Center of Excellence in Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Phnom Penh, Cambodia.
Jessica ManningInternational Center of Excellence in Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Phnom Penh, Cambodia.
Anna DurbinDepartment of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Stephen S WhiteheadArbovirus Vaccine Research Section, Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Leah C KatzelnickViral Epidemiology and Immunity Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA. leah.katzelnick@nih.gov.
National Institute of Allergy and Infectious Diseases · USNational Institutes of Health · USNational Institutes of Health Clinical Center · USFrederick National Laboratory for Cancer Research · USJohns Hopkins University · USUniversity of Cambridge · GB

Funding

Clinical Trials of Biodefense Vaccines (Dengue, West Nile Virus, TBEV)ZIAAI000987 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI WHITEHEAD, STEPHEN · 2009 to 2025
$37.9M
International Research in Cambodia: Tropical Medicine and Vector Research ZIAAI001066 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI YEK, CHRISTINA · 2009 to 2025
$10.8M
Immunology, virology, and epidemiology of flaviviruses and other emerging virusesZIAAI001346 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI KATZELNICK, LEAH · 2021 to 2025
$7.1M
6 · The paper itself

Abstract

backgroundThe four co-circulating and immunologically interactive dengue virus serotypes (DENV1-4) pose a unique challenge to vaccine design because sub-protective immunity can increase the risk of severe dengue disease. Existing dengue vaccines have lower efficacy in DENV seronegative individuals but higher efficacy in DENV exposed individuals. There is an urgent need to identify immunological measures that are strongly associated with protection against viral replication and disease following sequential exposure to distinct serotypes. METHODS/

designThis is a phase 1 trial wherein healthy adults with neutralizing antibodies to zero (seronegative), one non-DENV3 (heterotypic), or more than one (polytypic) DENV serotype will be vaccinated with the live attenuated DENV3 monovalent vaccine rDEN3Δ30/31-7164. We will examine how pre-vaccine host immunity influences the safety and immunogenicity of DENV3 vaccination in a non-endemic population. We hypothesize that the vaccine will be safe and well tolerated, and all groups will have a significant increase in the DENV1-4 neutralizing antibody geometric mean titer between days 0 and 28. Compared to the seronegative group, the polytypic group will have lower mean peak vaccine viremia, due to protection conferred by prior DENV exposure, while the heterotypic group will have higher mean peak viremia, due to mild enhancement. Secondary and exploratory endpoints include characterizing serological, innate, and adaptive cell responses; evaluating proviral or antiviral contributions of DENV-infected cells; and immunologically profiling the transcriptome, surface proteins, and B and T cell receptor sequences and affinities of single cells in both peripheral blood and draining lymph nodes sampled via serial image-guided fine needle aspiration. DISCUSSION: This trial will compare the immune responses after primary, secondary, and tertiary DENV exposure in naturally infected humans living in non-endemic areas. By evaluating dengue vaccines in a new population and modeling the induction of cross-serotypic immunity, this work may inform vaccine evaluation and broaden potential target populations.

trial registrationNCT05691530 registered on January 20, 2023.

Indexed as

Dengue VaccinesSevere DengueAdultAntibodies, NeutralizingHumansVaccinationVaccines, AttenuatedViremiaAntibodies, NeutralizingDengue VaccinesVaccines, AttenuatedDengueGerminal centerLive-attenuatedLymph node aspiratesNatural infectionPrimarySecondaryTertiaryVaccine

Identifiers

PMID37221466
PMCPMC10204028
OpenAlexW4377821336

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.