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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07097480
Acronym
SIMVIR
Enrollment
80
Registered
2025-07-31
Start date
2025-08-14
Completion date
2028-08-31
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bites Monkey

Keywords

Antirabies, Virus, Bite, Infection

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.

Interventions

Blood samples of 40 ml will be taken.

Saliva samples will be collected

Sponsors

Institut Pasteur
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Study the prevalence of STLV-1 and SFV infections following an NHP bite.17 monthsDetection of specific antibodies and viral DNA against both viruses in blood.

Secondary

MeasureTime frameDescription
Identify risk and demographic factors associated with STLV-1 and SFV infection.17 monthsThe 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.

Other

MeasureTime frameDescription
Characterize detected STLV-1 and SFV viral strains17 monthsDetermination of complete viral sequences and integration sites in the human genome.
Determine the kinetics of appearance of viral markers (viral DNA and antibodies) for each virus17 monthsMeasurement of viral markers (SFV RNA and DNA, STLV-1 DNA, virus-specific IgM and IgG) in blood and saliva.

Countries

France

Contacts

Primary ContactFlorence BUSEYNE, PhD
florence.buseyne@pasteur.fr0145688899
Backup ContactPatrick HOCHEDEZ, Dr
patrick.hochedez@pasteur.fr0140669604

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026