NCT05443867 - Monkeypox ASymptomatic Shedding: Evaluation by Self-Sampling MPX-ASSESS | Crick | Crick

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

N/ACompletedNCT05443867

Institute of Tropical Medicine, Belgium27 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

27

Conditions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Until 21 days after contact with index case

Secondary Outcomes

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

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

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

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

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

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

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

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 developing symptoms within the follow-up period

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

Time frame: Until 21 days after contact with index case

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.

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

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

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 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 skin lesions

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 confirmed exposure to first PCR positivity

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 appearance of any symptom

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 skin lesions

Time from confirmed exposure to appearance of skin lesions

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

Description of the type of symptoms observed in monkeypox contacts

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

Time frame: within 3 weeks after last exposure

Frequency of symptoms observed in monkeypox contacts

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

Time frame: within 3 weeks after last exposure

Timing of symptoms observed in monkeypox contacts

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

Time frame: within 3 weeks after last exposure

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

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

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

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

Number of contacts with the defined risk and protective factors

Number of contacts with the defined risk and protective factors

Time frame: At baseline

Proportion of presence of defined factors in PCR positive contacts.

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 symptomatic PCR positive contacts

Proportion of presence of defined factors in symptomatic PCR positive contacts

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