Monkeypox ASymptomatic Shedding: Evaluation by Self-Sampling MPX-ASSESS

NCT05443867 | Completed

• 1 other identifier: MPX-Assess
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Monkeypox (MPX) is a viral zoonosis, caused by the Monkeypox virus (MPXV), a DNA virus that belongs to the Orthopoxvirus genus and is closely related to the variola virus, the causative agent of smallpox. Until recently the spread of MPX was mainly confined to the Central African rainforest and to parts of West Africa. However, in May 2022, several cases of MPX were detected throughout Europe and Northern America, albeit with a different presentation than previously seen. Many questions remain on this new presentation of the disease: what the exact mode of transmission is, how contagious the virus really is and whether asymptomatic carriers exist. With this study the researchers aim to perform a close follow-up study of close contacts of MPX confirmed cases. Participants are recruited among high and very high risk contacts of confirmed monkeypox patients that presented to the ITM for diagnosis (index). Contacts that are asymptomatic (for symptoms compatible with MPXV infection according to national case definitions) at the time of recruitment will be enrolled. Contacts of the index case that are symptomatic at recruitment or become symptomatic during follow-up will be invited for sample collection at different timepoints until 21 days after contact as suspect cases.

Conditions

Monkey Pox

Outcome Measures

Primary Outcomes (1)

• Secondary attack rate of MPXV infection in contacts, defined by PCR positivity on any sample

  Secondary attack rate of MPXV infection in contacts, defined by PCR positivity on any sample

  Until 21 days after contact with index case

Secondary Outcomes (19)

• Rate of seroconversion in contacts, defined as a positive IgG (immunoglobulineG) for monkeypox

  Until 21 days after contact with index case

• Proportion of seroconversion in PCR positive contacts vs PCR negative contacts, defined as negative MPXV PCR in all samples until the end of the follow-up period

  Until 21 days after contact with index case

• Time to seroconversion overall, in symptomatic and asymptomatic contacts, and in PCR positive and negative cases

  Until 21 days after contact with index case

• Proportion of PCR positive participants with asymptomatic infection at time of first positive PCR

  Until 21 days after contact with index case

• Proportion of PCR positive participants developing symptoms within the follow-up period

  Until 21 days after contact with index case

Other Outcomes (1)

• Presence of culturable virus in PCR positive samples from pre- or asymptomatic period

  Until the end of the 3-week follow-up period

Study Arms (1)

MPX-Assess

Contacts of MPX index cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants are recruited among high and very high risk contacts of confirmed monkeypox patients that presented to the ITM for diagnosis (index). Contacts that are asymptomatic (for symptoms compatible with MPXV infection according to national case definitions) at the time of recruitment will be enrolled.

You may qualify if:

• Be a high risk or very high-risk contact of a laboratory confirmed monkeypox case, with:
• Very high-risk contact:
• Sexual partner(s)
• Prolonged skin-to-skin contact while the patient had skin lesions
• High risk contact
• living in the same household or similar environment (e.g. camping, spending the night, etc.);
• shared clothing, bedding, utensils, etc., while the patient had skin lesions
• healthcare workers with unprotected contact (inadequate or no PPE)
• Last exposure to the monkeypox index case of less than 21 days ago
• Adult participants (≥ 18 years old) of any gender
• Written informed consent is obtained from the participant

You may not qualify if:

• Presenting with symptoms compatible with MPX:
• an unexplained rash on any part of the body AND
• one or more of the following symptoms: fever, headache, back pain, fatigue, lymphadenopathy (localised or generalised)
• Inability or unwillingness to comply with the proposed follow-up schedule

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead

Study Sites (1)

Institute of Tropical Medicine Antwerp

Antwerp, 2000, Belgium

Location

Related Publications (1)

• Brosius I, Van Dijck C, Coppens J, Vandenhove L, Bangwen E, Vanroye F, Verschueren J; ITM MPOX Study Group; Zange S, Bugert J, Michiels J, Bottieau E, Soentjens P, van Griensven J, Kenyon C, Arien KK, Van Esbroeck M, Vercauteren K, Liesenborghs L. Presymptomatic viral shedding in high-risk mpox contacts: A prospective cohort study. J Med Virol. 2023 May;95(5):e28769. doi: 10.1002/jmv.28769.

  PMID: 37212312 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

* Blood * Oropharyngeal swab * Anal swab (self-sampling) * Genital swab (self-sampling) * Saliva (self-sampling)

MeSH Terms

Conditions

Mpox, Monkeypox

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Primate Diseases; Animal Diseases; Rodent Diseases

Study Officials

• Laurens Liesenborghs, MD

  Instituut van Tropische Geneeskunde Antwerpen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: July 5, 2022
• Study Start: June 22, 2022
• Primary Completion: August 25, 2022
• Study Completion: August 25, 2022
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)