Rabies Post-exposure ProphylaxisNCT05684185
Immunogenicity Assessment of Subjects Receiving Rabies Post-exposure Prophylaxis in Cambodia
An observational study of Rabies Post-exposure Prophylaxis, run by Institut Pasteur du Cambodge at 1 site in Cambodia.
Trial summary
A rabies virus neutralizing antibody (RVNA) concentration ≥ 0.5 IU/ml at 14 days after immunization is considered a proxy for protection in vaccine efficacy studies. Abridged and dose-sparing vaccination regimens increase accessibility and reduce both direct and indirect costs, especially in resource-constrained… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Rabies Post-exposure Prophylaxis
- What is being tested?
- Intramuscular (IM) rabies post-exposure prophylaxis and Intradermal (ID) rabies post-exposure prophylaxis
- Type of treatment
- Injection or infusion
- How many people
- 215 participants
- Where
- 1 siteCambodia
- Study dates
- 15 Jul 2020to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients seeking for rabies post-exposure prophylaxis (PEP) at the rabies prevention center of Institut Pasteur du Cambodge
Who may be able to join
- Subjects entering a rabies post-exposure vaccination course whatever the vaccine used with or without administration of rabies immunoglobulin (RIGs).
- Subjects with ability to attend all scheduled visits and to comply with all study procedures
Who cannot join
- Subjects with history of previous rabies vaccination
Trial locations and contacts
1 site in 1 country.
About this study
A rabies virus neutralizing antibody (RVNA) concentration ≥ 0.5 IU/ml at 14 days after immunization is considered a proxy for protection in vaccine efficacy studies. Abridged and dose-sparing vaccination regimens increase accessibility and reduce both direct and indirect costs, especially in resource-constrained countries where RABV prevalence is highest. Several efficacy studies evaluated safety and immunogenicity of abridged regimens in healthy adult volunteers using either four-site intradermal (ID) or intramuscular (IM) regimens, showing them to be safe and immunogenic.
Researchers at the Institut Pasteur du Cambodge (IPC) have previously conducted a retrospective study on clinical outcome at ≥6 months in 3318 Cambodians who received intradermal Vero cell vaccine post-exposure prophylaxis after a bite by a rabid or sick-looking but untested dog in 2003-2014. Here, the investigators could show that there was no significant difference in survival among patients who received 3 versus 4 sessions of the Thai Red Cross (TRC) ID regimen. In a separate study, investigators measured antibody responses in order to evaluate the immunogenicity of the TRC regiment after 3 sessions versus 4 sessions. The investigators did not observe an increase in rabies virus seroneutralization titers 14 days after the fourth immunization compared to 14 days after the third immunization. These results contributed to changes endorsed by the WHO in its April 2018 guidelines. The "Institut Pasteur du Cambodge (IPC) regimen" of three PEP sessions of two-site ID 0.1 mL vaccine doses each at days 0, 3 and 7 is the first one-week PEP regimen to be recommended.
In the current research project, the aim is to compare further different PEP vaccination strategies in a real life setting of individuals attending the rabies vaccination center at Institut Pasteur du Cambodge (IPC) in Phom Penh, Cambodia. The antibody kinetics and cellular immune responses in patients following either the one-week, 2-site ID regimen (IPC regimen) or the two-week IM regimen (4-dose regimen) as well as the participants' survival for both protocols after 6 months are evaluated.
- Conditions
- Rabies Post-exposure Prophylaxis
- Being tested
- Intramuscular (IM) rabies post-exposure prophylaxis, Intradermal (ID) rabies post-exposure prophylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramuscular (IM) rabies post-exposure prophylaxisBiological
one-site, 0.5 mL at Day 0, D3, D7 and D14
Intradermal (ID) rabies post-exposure prophylaxisBiological
two-site, 0.1 mL at Day 0, D3 and D7
| Study group | Role | What they receive |
|---|---|---|
| IM, <15 years old | Group with Intramuscular (IM) rabies post-exposure prophylaxis Receives: Biological: Intramuscular (IM) rabies post-exposure prophylaxis | |
| IM, 15 years old and older | Group with Intramuscular (IM) rabies post-exposure prophylaxis Receives: Biological: Intramuscular (IM) rabies post-exposure prophylaxis | |
| ID, <15 years old | Group with Intradermal (ID) rabies post-exposure prophylaxis Receives: Biological: Intradermal (ID) rabies post-exposure prophylaxis | |
| ID, 15 years old and older | Group with Intradermal (ID) rabies post-exposure prophylaxis Receives: Biological: Intradermal (ID) rabies post-exposure prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of the level of rabies virus neutralizing antibodies at 14 days and 18 days after first dose among patients receiving post-exposure prophylaxis (PEP) using intramuscular (IM) and intradermal (ID) protocols
Assessment of humoral immune response (rabies virus neutralizing antibodies - RVNA - titers measured with Fluorescent Antibody Virus Neutralization test - FAVN - by local laboratory) at different time points: at baseline before the first PEP dose, 14 days and 28 days after the first PEP dose, in each study group (IM / ID)
Measured: Day 0 (the first PEP dose), then 14 days and 28 days after Day 0 in each study group (IM / ID)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start15 Jul 2020
- Primary completion1 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rabies Post-exposure ProphylaxisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur du Cambodge
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi Pasteur, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- Sowath LY, PhD, Principal investigator, Institut Pasteur du Cambodge (IPC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684185
- Sponsor's protocol ID
- RAB00056
- Status last verified
- Jan 2023
- First submitted
- 16 Oct 2022
- Last updated
- 13 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity Assessment of Subjects Receiving Rabies Post-exposure Prophylaxis in Cambodia
- ClinicalTrials.gov ID
- NCT05684185
- Acronym / sponsor ID
- RAB00056
- Conditions
- Rabies Post-exposure Prophylaxis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Institut Pasteur du CambodgeUniversity, hospital or other
- Collaborators
- Sanofi Pasteur, a Sanofi Company
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 13 Jan 2023 (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.
A rabies virus neutralizing antibody (RVNA) concentration ≥ 0.5 IU/ml at 14 days after immunization is considered a proxy for protection in vaccine efficacy studies. Abridged and dose-sparing vaccination regimens increase accessibility and reduce both direct and indirect costs, especially in resource-constrained countries where RABV prevalence is highest. Several efficacy studies evaluated safety and immunogenicity of abridged regimens in healthy adult volunteers using either four-site intradermal (ID) or intramuscular (IM) regimens, showing them to be safe and immunogenic.
Researchers at the Institut Pasteur du Cambodge (IPC) have previously conducted a retrospective study on clinical outcome at ≥6 months in 3318 Cambodians who received intradermal Vero cell vaccine post-exposure prophylaxis after a bite by a rabid or sick-looking but untested dog in 2003-2014. Here, the investigators could show that there was no significant difference in survival among patients who received 3 versus 4 sessions of the Thai Red Cross (TRC) ID regimen. In a separate study, investigators measured antibody responses in order to evaluate the immunogenicity of the TRC regiment after 3 sessions versus 4 sessions. The investigators did not observe an increase in rabies virus seroneutralization titers 14 days after the fourth immunization compared to 14 days after the third immunization. These results contributed to changes endorsed by the WHO in its April 2018 guidelines. The "Institut Pasteur du Cambodge (IPC) regimen" of three PEP sessions of two-site ID 0.1 mL vaccine doses each at days 0, 3 and 7 is the first one-week PEP regimen to be recommended.
In the current research project, the aim is to compare further different PEP vaccination strategies in a real life setting of individuals attending the rabies vaccination center at Institut Pasteur du Cambodge (IPC) in Phom Penh, Cambodia. The antibody kinetics and cellular immune responses in patients following either the one-week, 2-site ID regimen (IPC regimen) or the two-week IM regimen (4-dose regimen) as well as the participants' survival for both protocols after 6 months are evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IM, <15 years old | – | Biological: Intramuscular (IM) rabies post-exposure prophylaxisGroup with Intramuscular (IM) rabies post-exposure prophylaxis |
| IM, 15 years old and older | – | Biological: Intramuscular (IM) rabies post-exposure prophylaxisGroup with Intramuscular (IM) rabies post-exposure prophylaxis |
| ID, <15 years old | – | Biological: Intradermal (ID) rabies post-exposure prophylaxisGroup with Intradermal (ID) rabies post-exposure prophylaxis |
| ID, 15 years old and older | – | Biological: Intradermal (ID) rabies post-exposure prophylaxisGroup with Intradermal (ID) rabies post-exposure prophylaxis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients seeking for rabies post-exposure prophylaxis (PEP) at the rabies prevention center of Institut Pasteur du Cambodge
Key inclusion criteria (2 listed)
- Subjects entering a rabies post-exposure vaccination course whatever the vaccine used with or without administration of rabies immunoglobulin (RIGs).
- Subjects with ability to attend all scheduled visits and to comply with all study procedures
Key exclusion criteria (1 listed)
- Subjects with history of previous rabies vaccination
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 |
|---|---|---|
| Intramuscular (IM) rabies post-exposure prophylaxisone-site, 0.5 mL at Day 0, D3, D7 and D14 | Biological | IM, 15 years old and older, IM, <15 years old |
| Intradermal (ID) rabies post-exposure prophylaxistwo-site, 0.1 mL at Day 0, D3 and D7 | Biological | ID, 15 years old and older, ID, <15 years old |
Primary outcome
Changes of the level of rabies virus neutralizing antibodies at 14 days and 18 days after first dose among patients receiving post-exposure prophylaxis (PEP) using intramuscular (IM) and intradermal (ID) protocols
Time frame: Day 0 (the first PEP dose), then 14 days and 28 days after Day 0 in each study group (IM / ID)
Assessment of humoral immune response (rabies virus neutralizing antibodies - RVNA - titers measured with Fluorescent Antibody Virus Neutralization test - FAVN - by local laboratory) at different time points: at baseline before the first PEP dose, 14 days and 28 days after the first PEP dose, in each study group (IM / ID)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Sowath LY, PhD principal investigator
Institut Pasteur du Cambodge (IPC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rabies Post-exposure Prophylaxis, run by Institut Pasteur du Cambodge at 1 site in Cambodia.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 13 Jan 2023. 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 Cambodia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of the level of rabies virus neutralizing antibodies at 14 days and 18 days after first dose among patients receiving post-exposure prophylaxis (PEP) using intramuscular (IM) and intradermal (ID) protocols (time frame: Day 0 (the first PEP dose), then 14 days and 28 days after Day 0 in each study group (IM / ID)). 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 13 Jan 2023.