Target Trial Emulation of the Modified Vaccinia Ankara-Bavarian Nordic Vaccine for Pre-Exposure Mpox Prevention in At-Risk Populations
Suñer, Clara (Institut Germans Trias i Pujol. Fundació Lluita Contra les Infeccions)
Escrig-Sarreta, Roser (Institut Germans Trias i Pujol. Fundació Lluita Contra les Infeccions)
Galván-Casas, Cristina (Institut Germans Trias i Pujol. Fundació Lluita Contra les Infeccions)
Matos, Eduardo (Arzobispo Loayza National Hospital (Lima, Perú))
Gabster, Amanda (Instituto Conmemorativo Gorgas de Estudios de la Salud)
Wolff, Marcelo (Hospital San Borja Arriarán)
Ouchi, Dan (Institut Germans Trias i Pujol. Fundació Lluita Contra les Infeccions)
Alemany, Andrea (Institut Germans Trias i Pujol. Fundació Lluita Contra les Infeccions)
Sánchez, Hugo (Universidad Nacional Mayor de San Marcos (Lima, Perú))
Huaman, Sandra (Comprehensive Medical Center Semedi (Lima, Perú))
Bejarano, Dixennia (Instituto Conmemorativo Gorgas de Estudios de la Salud)
Carrés-Esteve, Lourdes (Institut Català de la Salut)
Santiago-Fernández, Cristina (Institut Català de la Salut)
Corral-Rubio, Javier (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Mendoza, Adrià (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Rivero, Ángel (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Descalzo Jorro, Vicente (Hospital Universitari Vall d'Hebron)
Orviz, Eva (Centro Sanitario Sandoval)
Martínez Riveros, Héctor (Institut Germans Trias i Pujol)
Méndez-Boo, Leonardo (Institut Català de la Salut)
Cabezas Peña, Carmen (Generalitat de Catalunya. Departament de Salut)
Arce-Arnáez, Araceli (Dirección General de Salud Pública. Comunidad de Madrid Consejeria de Sanidad)
Marks, Michael (University College London)
Mitjà, Oriol (Universitat Autònoma de Barcelona. Departament de Medicina)

Date:	2025
Abstract:	Background: The MVA-BN vaccine is considered effective for preventing mpox in key populations, based on observational studies, though no randomized trials have yet confirmed its effectiveness. Observational studies published to date rely on retrospective analyses of routine data, often missing information on relevant risk factors for mpox. Methods: Multi-country target trial emulation study with prospective data collection. Between 1 September 2022 and 15 June 2023, we recruited individuals eligible for mpox vaccination based on clinical history and exposure behaviors via healthcare centers and social venues in Spain, Peru, Panama, and Chile. Vaccinated individuals were paired with unvaccinated counterparts matched by mpox risk factors, country, recruitment date, and age. Follow-up continued via periodic surveys until 31 March 2024. The primary endpoint was symptomatic mpox occurrence ≥14 days post-vaccination. Results: The primary analysis included 1028 individuals (514 vaccinated, 514 unvaccinated) with a median follow-up time of 9. 3 months (IQR 4. 7-13. 7). Mpox occurred in eight participants (0. 8%): three vaccinated and five unvaccinated (HR 0. 6; 95% CI 0. 21-1. 70). Adverse reactions were reported by 731 (49. 6%) participants, predominantly skin reactions (703/1475; 47. 7%), while systemic reactions occurred in 107 (7. 3%). Long-lasting erythema at the injection site was reported in 450/1058 (42. 5%) participants, persisting.
Grants:	European Commission 850450
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Mpox ; Vaccine ; MVA-BN ; Efficacy ; Safety ; Target trial emulation
Published in:	Vaccines (Basel), Vol. 13 Núm. 6 (May 2025) , p. 594, ISSN 2076-393X

DOI: 10.3390/vaccines13060594
PMID: 40573925

16 p, 825.1 KB

The record appears in these collections:
Articles > Research articles
Articles > Published articles