Virus Transmission to People Recently Bitten or With a History of Monkey Bites "SIMVIR
ConditionBites Monkey
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Pasteur
About this trial
Nonhuman primates (NHPs) constitute an important reservoir of infectious agents, some of which have emerged in human populations as deadly pathogens. Human exposure to the biological fluids of NHPs - particularly through bites - can result in the transmission of several viruses. Only the rabies virus is currently targeted by post-exposure prophylaxis following an injury caused by an NHP.
The objective of the study is to investigate the prevalence of STLV-1 and SFV infections following a nonhuman primate bite.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Bite inflicted by an HNP (WHO category 3 level)
Written informed consent
Affiliation with a social security scheme (excluding State Medical Aid
Disqualifiers
Patient presenting only with scratches inflicted by a PNH
Medical management incompatible with the objectives of the study
Patient who, in the doctor's opinion, is unlikely to comply with the study protocol
Health conditions are incompatible with the sample collection required by the study
Trial design
Design model
Parallel
Treatments tested in this trial
Blood samples collection
Procedure/SurgeryBlood samples of 40 ml will be taken.
Saliva samples collection
Procedure/SurgerySaliva samples will be collected
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Adults recently bitten by a non-human primateOther 2 interventions
Group B: Adults with a history of bitesOther 2 interventions
Trial outcomes
Primary outcomes
1
Study the prevalence of STLV-1 and SFV infections following an NHP bite.
Detection of specific antibodies and viral DNA against both viruses in blood.
Time frame
17 monthsSecondary outcomes
1
Identify risk and demographic factors associated with STLV-1 and SFV infection.
The study of associations between STLV-1 and SFV infection and demographic characteristics (age, sex) and those linked to the HNP bite (severity of injury, HNP species) will be analyzed by Fisher's exact test and the Mann-Withney test.
Time frame
17 monthsOther outcomes
1
Determine the kinetics of appearance of viral markers (viral DNA and antibodies) for each virus
Measurement of viral markers (SFV RNA and DNA, STLV-1 DNA, virus-specific IgM and IgG) in blood and saliva.
Time frame
17 months2
Characterize detected STLV-1 and SFV viral strains
Determination of complete viral sequences and integration sites in the human genome.
Time frame
17 monthsSponsors and contacts
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Source ClinicalTrials.gov