NCT05522296

Brief Summary

The purpose of this study is to assess the protection of smallpox preexposure vaccination against infection with mpox in real-world individuals with risk factors for mpox.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,125

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
4 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 31, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

September 12, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

June 6, 2024

Status Verified

June 1, 2024

Enrollment Period

1.5 years

First QC Date

August 27, 2022

Last Update Submit

June 5, 2024

Conditions

Mpox

Keywords

MonkeypoxMpox VaccineIntradermal Mpox vaccineMpox

Outcome Measures

Primary Outcomes (1)

  • Polymerase chain reaction (PCR)-confirmed mpox infection

    Mpox PCR positivity in participants with mpox infection symptoms

    From 14 days after the index date to twelve months after the index date

Secondary Outcomes (8)

  • Polymerase chain reaction (PCR)-confirmed mpox infection

    From immediately after the index date to twelve months after the index date

  • Duration of general symptoms

    From 14 days after the index date to twelve months after the index date

  • Severity of rash

    From 14 days after the index date to twelve months after the index date

  • Duration of skin rash

    From 14 days after the index date to twelve months after the index date

  • Medical treatment

    From 14 days after the index date to twelve months after the index date

  • +3 more secondary outcomes

Study Arms (2)

Unvaccinated

Unvaccinated individuals who have risk factors for mpox infection and do not have a past history of mpox infection

Vaccinated

Vaccinated individuals with smallpox and mpox vaccine (Live Modified Vaccinia Virus Ankara) who have risk factors for monkeypox infection and do not have a past history of mpox infection.

Drug: Mpox Vaccine

Interventions

Mpox VaccineDRUG

Vaccination with smallpox and mpox vaccine (Live Modified Vaccinia Virus Ankara)

Vaccinated

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale cis and Female trans
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Vaccinated and unvaccinated individuals who have risk factors for mpox infection and do not have a past history of mpox infection.

You may qualify if:

  • Individuals aged 18 years or older.
  • Individuals with general risk factors for mpox infection, as currently defined by the local guidelines for vaccination. These risk factors include at least one of the following items:
  • Individual-reported use of HIV pre-exposure prophylaxis (PrEP).
  • Individual-reported chemsex practices
  • Individual-reported multiple sexual partners.
  • Individuals with a history of a sexually transmitted infection (STI) in the past year.
  • Individuals living with HIV infection.
  • Signature of informed consent.

You may not qualify if:

  • Unable to provide signature of informed consent.
  • Past infection with monkeypox.
  • Past smallpox vaccination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital Clínico San Borja Arriarán

Santiago, Santiago Metropolitan, 8360154, Chile

Location

Instituto Conmemorativo Gorgas de Estudios de la Salud (ICGES)

Panama City, Panama

Location

Hospital Regional III Honorio Delgado

Arequipa, Peru

Location

Hospital Nacional Arzobispo Loayza

Lima, 15082, Peru

Location

Hospital Regional Docente de Trujillo

Trujillo, 13011, Peru

Location

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

Related Publications (1)

  • Barda N, Dagan N, Ben-Shlomo Y, Kepten E, Waxman J, Ohana R, Hernan MA, Lipsitch M, Kohane I, Netzer D, Reis BY, Balicer RD. Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting. N Engl J Med. 2021 Sep 16;385(12):1078-1090. doi: 10.1056/NEJMoa2110475. Epub 2021 Aug 25.

    PMID: 34432976BACKGROUND

Related Links

MeSH Terms

Conditions

Mpox, Monkeypox

Interventions

Smallpox Vaccine

Condition Hierarchy (Ancestors)

Poxviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsPrimate DiseasesAnimal DiseasesRodent Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
18 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Infectious Diseases and Global Health

Study Record Dates

First Submitted

August 27, 2022

First Posted

August 31, 2022

Study Start

September 12, 2022

Primary Completion

March 30, 2024

Study Completion

March 30, 2024

Last Updated

June 6, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

Upon request after publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
After Publication

Locations

ES(1)PE(3)PA(1)CL(1)