Clinical trial NCT05443867: Monkeypox ASymptomatic Shedding: Evaluation by Self-Sampling MPX-ASSESS
Official title: Monkeypox ASymptomatic Shedding: Evaluation by Self-Sampling MPX-ASSESS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Monkey Pox
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

1. 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)
2. Last exposure to the monkeypox index case of less than 21 days ago
3. Adult participants (≥ 18 years old) of any gender
4. Written informed consent is obtained from the participant

Exclusion Criteria:

1. 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)
2. Inability or unwillingness to comply with the proposed follow-up schedule

Primary outcomes:
measure: Secondary attack rate of MPXV infection in contacts, defined by PCR positivity on any sample
timeFrame: Until 21 days after contact with index case
Secondary outcomes:
measure: Rate of seroconversion in contacts, defined as a positive IgG (immunoglobulineG) for monkeypox
timeFrame: Until 21 days after contact with index case
measure: 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
timeFrame: Until 21 days after contact with index case
measure: Time to seroconversion overall, in symptomatic and asymptomatic contacts, and in PCR positive and negative cases
timeFrame: Until 21 days after contact with index case
measure: Proportion of PCR positive participants with asymptomatic infection at time of first positive PCR
timeFrame: Until 21 days after contact with index case
measure: Proportion of PCR positive participants developing symptoms within the follow-up period
timeFrame: Until 21 days after contact with index case
measure: 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.
timeFrame: within 3 weeks after exposure or within 1 week after PCR positivity, whichever follow-up is longer
measure: 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)
timeFrame: at the end of the 3-week follow-up period
measure: Time from MPXV PCR positivity in any sample to appearance of skin lesions
timeFrame: at the end of the 3-week follow-up period
measure: Time from confirmed exposure to first PCR positivity
timeFrame: at the end of the 3-week follow-up period
measure: Time from confirmed exposure to appearance of any symptom
timeFrame: at the end of the 3-week follow-up period
measure: Time from confirmed exposure to appearance of skin lesions
timeFrame: at the end of the 3-week follow-up period
measure: Description of the type of symptoms observed in monkeypox contacts
timeFrame: within 3 weeks after last exposure
measure: Frequency of symptoms observed in monkeypox contacts
timeFrame: within 3 weeks after last exposure
measure: Timing of symptoms observed in monkeypox contacts
timeFrame: within 3 weeks after last exposure
measure: Distribution of skin lesions for sexual contacts versus close personal contacts. (per body surface and per category: local vs generalized skin lesions)
timeFrame: at the end of the 3-week follow-up period
measure: Proportion of contacts presenting with systemic symptoms after sexual exposure versus those with close personal contacts exposure
timeFrame: at the end of the 3-week follow-up period
measure: Number of contacts with the defined risk and protective factors
timeFrame: At baseline
measure: Proportion of presence of defined factors in PCR positive contacts.
timeFrame: Until the end of the 3-week follow-up period
measure: Proportion of presence of defined factors in symptomatic PCR positive contacts
timeFrame: Until the end of the 3-week follow-up period
Other outcomes:
measure: Presence of culturable virus in PCR positive samples from pre- or asymptomatic period
timeFrame: Until the end of the 3-week follow-up period
Locations:
city: Antwerpen
country: Belgium
facility: Institute of Tropical Medicine Antwerp
Study officials:
affiliation: Instituut van Tropische Geneeskunde Antwerpen
name: Laurens Liesenborghs, MD
role: PRINCIPAL_INVESTIGATOR
References: