Evidence map›Paper›PMID 40321446›Full record

ArticleGlobal health & medicine2025

Key success factors in clinical trial operation of the smallpox vaccine LC16m8 against mpox in Colombia.

Naoki Tomotsugu, Maria Jose Amaya-Mahecha, Mieko Hamana, María Del Mar Bautista-Gonzalez, Hernando Guillermo Gaitán-Duarte, Jorge Alberto Cortés, Sohtaro Mine, Akira Ainai, Jaime E Castellanos, Daisuke Tokita and 3 more

Abstract readLetter
In one paragraph

Article in Global health & medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

13 authors.

Naoki TomotsuguNational Center for Global Health and Medicine, Tokyo, Japan.
Maria Jose Amaya-MahechaUniversidad Nacional de Colombia, Bogotá, Colombia.
Mieko HamanaNational Center for Global Health and Medicine, Tokyo, Japan.
María Del Mar Bautista-GonzalezUniversidad Nacional de Colombia, Bogotá, Colombia.
Hernando Guillermo Gaitán-DuarteUniversidad Nacional de Colombia, Bogotá, Colombia.
Jorge Alberto CortésUniversidad Nacional de Colombia, Bogotá, Colombia.
Sohtaro MineNational Center for Global Health and Medicine, Tokyo, Japan.
Akira AinaiNational Center for Global Health and Medicine, Tokyo, Japan.
Jaime E CastellanosUniversidad Nacional de Colombia, Bogotá, Colombia.
Daisuke TokitaNational Center for Global Health and Medicine, Tokyo, Japan.
Wataru SugiuraNational Center for Global Health and Medicine, Tokyo, Japan.
Mugen UjiieNational Center for Global Health and Medicine, Tokyo, Japan.
Carlos Arturo Álvarez-MorenoUniversidad Nacional de Colombia, Bogotá, Colombia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In 2023, the Japan Institute for Health Security (JIHS) and the Universidad Nacional de Colombia (UNAL) conducted a successful clinical trial of the LC16m8 mpox vaccine in Colombia. The joint Japan-Colombia research team categorized the trial's challenges and success factors into several key operational aspects for analysis. Key success factors were an established database of Colombian human immunodeficiency virus (HIV) patient and pre-exposure prophylaxis (PrEP) population registries, and strong experience with large-scale clinical trials of HIV and COVID-19. In addition, a strong network of infectious disease specialists in Colombia enabled close communication between the study site directors and the research team. This allowed for rapid staffing and training, which was consistent with the study schedule. The outcome of this research identifies key success factors for the immediate implementation of large-scale clinical trials and will contribute to preparedness for future pandemics.

Indexed as

HIVpandemicPrEPpreparedness

Identifiers

PMID40321446
PMCPMC12047037

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.