NCT07097480

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
27mo left

Started Aug 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Aug 2025Aug 2028

First Submitted

Initial submission to the registry

July 25, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

August 14, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

December 15, 2025

Status Verified

July 1, 2025

Enrollment Period

1.3 years

First QC Date

July 25, 2025

Last Update Submit

December 8, 2025

Conditions

Keywords

AntirabiesVirusBiteInfection

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

OTHER

Adults recently bitten by a non-human primate and consulting at the Institut Pasteur medical center for prophylaxis as part of their care.

Procedure: Blood samples collectionProcedure: Saliva samples collection

Adults with a history of bites

OTHER

Adults 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.

Procedure: Blood samples collectionProcedure: Saliva samples collection

Interventions

Blood samples of 40 ml will be taken.

Adults recently bitten by a non-human primateAdults with a history of bites

Saliva samples will be collected

Adults recently bitten by a non-human primateAdults with a history of bites

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Institut Pasteur Medical Center

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

Virus DiseasesBites and StingsInfections

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • Patrick HOCHEDEZ, Dr

    Institut Pasteur Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Florence BUSEYNE, PhD

CONTACT

Patrick HOCHEDEZ, Dr

CONTACT

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

Locations