Virus Transmission to People Recently Bitten or With a History of Monkey Bites "SIMVIR

Not Applicable

Not yet recruiting

• Conditions: Bites Monkey

• Registration Number: NCT07097480
• Lead Sponsor: Institut Pasteur

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.

Detailed Description

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.

Compared to other individuals exposed to nonhuman primates (NHPs), travelers have two unique characteristics. First, they are typically exposed only once to simian infectious agents, in contrast to the repeated exposure experienced by other at-risk groups. If exposure results in an infection event, travelers may spread these infectious agents to geographic areas where they do not normally circulate.

To address the following main objective: to study the prevalence of STLV-1 and SFV infections following a nonhuman primate bite. The study plans to include subjects who have been recently bitten as well as those with a history of nonhuman primate bites. Blood and saliva samples will be collected from the subjects.

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted: 2025-07-25
• Study First Submitted QC: 2025-07-25
• Last Update Submitted: 2025-07-25
• Study First Posted: 2025-07-31
• Last Update Posted: 2025-07-31
• Primary Completion: 2026-11
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Study the prevalence of STLV-1 and SFV infections following an NHP bite.	17 months	Detection of specific antibodies and viral DNA against both viruses in blood.

Secondary Outcome Measures

Name	Time	Method
Identify risk and demographic factors associated with STLV-1 and SFV infection.	17 months	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.

Trial Locations

Locations (1)

Institut Pasteur Medical Center; 🇫🇷 Paris, France