Skip to main content
OpenTrials
Completed

NCT Number: NCT05443867

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Monkey Pox Animal Diseases DNA Virus Infections Infections Mpox, Monkeypox Poxviridae Infections Primate Diseases Rodent Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Tropical Medicine Antwerp

Antwerp, 2000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

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

    Time frame: Until 21 days after contact with index case

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

Secondary outcomes

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

    Time frame: Until 21 days after contact with index case

    To evaluate the rate of seroconversion in contacts (positive IgG for MPX) within 21 days after contact with index case

  2. 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

    Time frame: 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

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

    Time frame: Until 21 days after contact with index case

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

  4. Proportion of PCR positive participants with asymptomatic infection at time of first positive PCR

    Time frame: Until 21 days after contact with index case

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

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

    Time frame: Until 21 days after contact with index case

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

  6. Proportion of asymptomatic infections on number of contacts in follow-up. Asymptomatic infections are defined as contacts with positive MPXV PCR on any clinical sample, without development of any symptoms.

    Time frame: within 3 weeks after exposure or within 1 week after PCR positivity, whichever follow-up is longer

    Proportion of asymptomatic infections on number of contacts in follow-up. Asymptomatic infections are defined as contacts with positive MPXV PCR on any clinical sample, without development of any symptoms within 3 weeks after exposure or within 1 week after PCR positivity, whichever follow-up is longer

  7. Time from MPXV PCR positivity in any sample to appearance of any symptom overall and per mode of transmission (close personal contact; anal, vaginal or oral receptive sexual contact; and insertive sexual contact)

    Time frame: at the end of the 3-week follow-up period

    Time from MPXV PCR positivity in any sample to appearance of any symptom overall and per mode of transmission (close personal contact; anal, vaginal or oral receptive sexual contact; and insertive sexual contact)

  8. Time from MPXV PCR positivity in any sample to appearance of skin lesions

    Time frame: at the end of the 3-week follow-up period

    Time from MPXV PCR positivity in any sample to appearance of skin lesions

  9. Time from confirmed exposure to first PCR positivity

    Time frame: at the end of the 3-week follow-up period

    Time from confirmed exposure to first PCR positivity

  10. Time from confirmed exposure to appearance of any symptom

    Time frame: at the end of the 3-week follow-up period

    Time from confirmed exposure to appearance of any symptom

  11. Time from confirmed exposure to appearance of skin lesions

    Time frame: at the end of the 3-week follow-up period

    Time from confirmed exposure to appearance of skin lesions

  12. Description of the type of symptoms observed in monkeypox contacts

    Time frame: within 3 weeks after last exposure

    Description of the type of symptoms observed in monkeypox contacts within 3 weeks after last exposure

  13. Frequency of symptoms observed in monkeypox contacts

    Time frame: within 3 weeks after last exposure

    Frequency of symptoms observed in monkeypox contacts within 3 weeks after last exposure

  14. Timing of symptoms observed in monkeypox contacts

    Time frame: within 3 weeks after last exposure

    Timing of symptoms observed in monkeypox contacts within 3 weeks after last exposure

  15. Distribution of skin lesions for sexual contacts versus close personal contacts. (per body surface and per category: local vs generalized skin lesions)

    Time frame: at the end of the 3-week follow-up period

    Distribution of skin lesions for sexual contacts versus close personal contacts. (per body surface and per category: local vs generalized skin lesions)

  16. Proportion of contacts presenting with systemic symptoms after sexual exposure versus those with close personal contacts exposure

    Time frame: at the end of the 3-week follow-up period

    Proportion of contacts presenting with systemic symptoms after sexual exposure versus those with close personal contacts exposure

  17. Number of contacts with the defined risk and protective factors

    Time frame: At baseline

    Number of contacts with the defined risk and protective factors

  18. Proportion of presence of defined factors in PCR positive contacts.

    Time frame: Until the end of the 3-week follow-up period

    Proportion of presence of defined factors in PCR positive contacts.

  19. Proportion of presence of defined factors in symptomatic PCR positive contacts

    Time frame: Until the end of the 3-week follow-up period

    Proportion of presence of defined factors in symptomatic PCR positive contacts

Other outcomes

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

    Time frame: Until the end of the 3-week follow-up period

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

Sponsors and collaborators

Lead sponsor

Institute of Tropical Medicine, Belgium

Other

Registry information

Acronym: MPX-Assess

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 5, 2022
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.