Bites MonkeySIMVIRNCT07097480
Virus Transmission to People Recently Bitten or With a History of Monkey Bites "SIMVIR
A study testing Blood samples collection and Saliva samples collection in people with Bites Monkey, run by Institut Pasteur at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bites Monkey
- What is being tested?
- Blood samples collection and Saliva samples collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 14 Aug 2025to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut Pasteur Medical Center
Paris, 75015
Patrick HOCHEDEZ, Dr
About this study
Official title: Virus Transmission to People Recently Bitten or With a History of Monkey Bites "SIMVIR"
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.
Read the 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.
- Conditions
- Bites Monkey
- Being tested
- Blood samples collection, Saliva samples collection
- Keywords
- Antirabies, Virus, Bite, Infection
- Medical subject headings
- Virus Diseases, Bites and Stings, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples collectionProcedure or surgery
Blood samples of 40 ml will be taken.
Saliva samples collectionProcedure or surgery
Saliva samples will be collected
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Blood samples collection; Procedure: 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. Receives: Procedure: Blood samples collection; Procedure: Saliva samples collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 17 months
Secondary 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.
Measured: 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start14 Aug 2025
- Primary completionDec 2026 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bites MonkeyStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick HOCHEDEZ, Dr, Principal investigator, Institut Pasteur Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097480
- Sponsor's protocol ID
- 2024-113
- Acronym
- SIMVIR
- Status last verified
- Jul 2025
- First submitted
- 25 Jul 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virus Transmission to People Recently Bitten or With a History of Monkey Bites "SIMVIR"
- ClinicalTrials.gov ID
- NCT07097480
- Acronym / sponsor ID
- SIMVIR / 2024-113
- Conditions
- Bites Monkey
- Keywords
- Antirabies, Virus, Bite, Infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults recently bitten by a non-human primate | Other | Procedure: Blood samples collection, Procedure: Saliva samples collectionAdults 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 | Other | Procedure: Blood samples collection, Procedure: Saliva samples collectionAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Participant has checked the boxes for participation in the genetic component.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples collectionBlood samples of 40 ml will be taken. | Procedure or surgery | Adults recently bitten by a non-human primate, Adults with a history of bites |
| Saliva samples collectionSaliva samples will be collected | Procedure or surgery | Adults recently bitten by a non-human primate, Adults with a history of bites |
Primary outcome
Study the prevalence of STLV-1 and SFV infections following an NHP bite.
Time frame: 17 months
Detection of specific antibodies and viral DNA against both viruses in blood.
1 secondary outcome
Identify risk and demographic factors associated with STLV-1 and SFV infection.
Time frame: 17 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick HOCHEDEZ, Dr principal investigator
Institut Pasteur Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples collection and Saliva samples collection in people with Bites Monkey, run by Institut Pasteur at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florence BUSEYNE, PhD (0145688899 ext. +33, florence.buseyne@pasteur.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study the prevalence of STLV-1 and SFV infections following an NHP bite. (time frame: 17 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.