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

Monkey Pox Clinical Trial

— MPX-Assess  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05443867
• Other study ID #: MPX-Assess
• Status: Completed
• Start date: June 22, 2022
• Est. completion date: August 25, 2022

Study information

• Verified date: September 2023
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 25, 2022
• Est. primary completion date: August 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Monkey Pox
• Monkeypox

Locations

Country	Name	City	State
Belgium	Institute of Tropical Medicine Antwerp	Antwerpen

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Presence of culturable virus in PCR positive samples from pre- or asymptomatic period	Presence of culturable virus in PCR positive samples from pre- or asymptomatic period	Until the end of the 3-week follow-up period
Primary	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	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	Until 21 days after contact with index case
Secondary	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	Until 21 days after contact with index case
Secondary	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	Until 21 days after contact with index case
Secondary	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	Until 21 days after contact with index case
Secondary	Proportion of PCR positive participants developing symptoms within the follow-up period	Proportion of PCR positive participants developing symptoms within the follow-up period	Until 21 days after contact with index case
Secondary	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	within 3 weeks after exposure or within 1 week after PCR positivity, whichever follow-up is longer
Secondary	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)	at the end of the 3-week follow-up period
Secondary	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	at the end of the 3-week follow-up period
Secondary	Time from confirmed exposure to first PCR positivity	Time from confirmed exposure to first PCR positivity	at the end of the 3-week follow-up period
Secondary	Time from confirmed exposure to appearance of any symptom	Time from confirmed exposure to appearance of any symptom	at the end of the 3-week follow-up period
Secondary	Time from confirmed exposure to appearance of skin lesions	Time from confirmed exposure to appearance of skin lesions	at the end of the 3-week follow-up period
Secondary	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	within 3 weeks after last exposure
Secondary	Frequency of symptoms observed in monkeypox contacts	Frequency of symptoms observed in monkeypox contacts within 3 weeks after last exposure	within 3 weeks after last exposure
Secondary	Timing of symptoms observed in monkeypox contacts	Timing of symptoms observed in monkeypox contacts within 3 weeks after last exposure	within 3 weeks after last exposure
Secondary	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)	at the end of the 3-week follow-up period
Secondary	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	at the end of the 3-week follow-up period
Secondary	Number of contacts with the defined risk and protective factors	Number of contacts with the defined risk and protective factors	At baseline
Secondary	Proportion of presence of defined factors in PCR positive contacts.	Proportion of presence of defined factors in PCR positive contacts.	Until the end of the 3-week follow-up period
Secondary	Proportion of presence of defined factors in symptomatic PCR positive contacts	Proportion of presence of defined factors in symptomatic PCR positive contacts	Until the end of the 3-week follow-up period