Virus Transmission to People Recently Bitten or With a History of Monkey Bites "SIMVIR
SIMVIR
1 other identifier
interventional
80
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2025
CompletedFirst Posted
Study publicly available on registry
July 31, 2025
CompletedStudy Start
First participant enrolled
August 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
December 15, 2025
July 1, 2025
1.3 years
July 25, 2025
December 8, 2025
Conditions
Keywords
Outcome Measures
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.
17 months
Secondary Outcomes (1)
Identify risk and demographic factors associated with STLV-1 and SFV infection.
17 months
Other Outcomes (2)
Determine the kinetics of appearance of viral markers (viral DNA and antibodies) for each virus
17 months
Characterize detected STLV-1 and SFV viral strains
17 months
Study Arms (2)
Adults recently bitten by a non-human primate
OTHERAdults recently bitten by a non-human primate and consulting at the Institut Pasteur medical center for prophylaxis as part of their care.
Adults with a history of bites
OTHERAdults with a history of bites from a non-human primate who are consulting at the Institut Pasteur medical center as part of their routine care.
Interventions
Blood samples of 40 ml will be taken.
Saliva samples will be collected
Eligibility Criteria
You may qualify if:
- 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
- Specific criteria for genetic analyses:
- Participant has checked the boxes for participation in the genetic component.
You may not qualify if:
- 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
- Patient under legal protection (guardianship or trusteeship)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Pasteurlead
Study Sites (1)
Institut Pasteur Medical Center
Paris, 75015, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick HOCHEDEZ, Dr
Institut Pasteur Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2025
First Posted
July 31, 2025
Study Start
August 14, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
August 1, 2028
Last Updated
December 15, 2025
Record last verified: 2025-07