RabiesRESIST-3NCT04829630
Immunity Persistence After Abridged Intradermal Rabies PEP
A study testing rabies vaccine in people with Rabies, run by Institut Pasteur at 2 sites in 2 countries.
Trial summary
After exposure, rabies can be prevented in almost 100% of cases by the administration of sufficient and timely post-exposure prophylaxis (PEP). PEP is based on wound cleansing, antisepsis, administration of rabies vaccine as well as rabies immunoglobulin, if reviewed. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Rabies
- What is being tested?
- rabies vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Oct 2021to 1 Feb 2023
- Phase
- Interventional
- 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
Who may be able to join
- person Identified in IP Cambodia or IP Madagascar records for having received ID PEP by 4 sessions/1 month or 3 sessions/1 week at least two, five or 10 years earlier, with no rabies boosting since that time;
- person Who received information adapter to his/her age and who signed the consent form (or his/her legal tutors)
Who cannot join
- person who received Rabies vaccine booster since the earlier PEP
- person with allergy or other severe unwanted effect at the time of the earlier PEP
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
After exposure, rabies can be prevented in almost 100% of cases by the administration of sufficient and timely post-exposure prophylaxis (PEP). PEP is based on wound cleansing, antisepsis, administration of rabies vaccine as well as rabies immunoglobulin, if reviewed. However, anti-rabies PEP remains too often out of financial and / or geographic access, especially for poor and / or rural populations in endemic countries who remain the most exposed to the risk of contracting rabies. Two major studies planned in Cambodia between 2014 and 2018 - the RESIST 0/1 clinical - epidemiological study and the RESIST-2 study on the antibody response to the vaccine - provided the basis that allowed a change in international recommendations on PPE. Since April 2018, the new "IPC protocol" of three sessions of reduced double doses (0.1 mL x 2) administered intradermally (ID) over one week has replaced the already very effective "TRC protocol" of four sessions over one month which was the reference dose-sparing protocol for endemic countries until 2018. It remains to be determined whether the IPC protocol (3 sessions / 1 week) confers long-term immunity equivalent to that obtained after a TRC ID protocol (4 sessions / 1 month). This question is of importance to public health decision-makers and clinical teams in endemic countries who would hesitate to switch to the abbreviated IPC protocol.
Read the detailed description
This is a multicenter, randomized, non-inferior clinical trial with samples for examinations and vaccination booster.
To achieve this study, persons who previously received PEP and of any age (including children), gender or medical condition (including pregnant women) and whichever the status of the dog which bit at least 2, 5 or 10 years ago will be contacted and invited to participate to the study.
This study will take place in two centers :
- The rabies prevention center at Institut Pasteur du Cambodge
- The rabies prevention center at Institut Pasteur de Madagascar. The study will be coordinated by Institut Pasteur in Paris which will subsequently conduct the analysis in collaboration with researchers at Institut Pasteur du Cambodge and Institut Pasteur de Madagascar.
This study will take place in two visits :
- the first visit (day 0) : after receiving consent from the participants, the member of the investigating team will perform the blood sample, followed by a single session of two intradermal doses of 0.1 mL. The investigators will also carry out measurements and complete the questionnaire with the participant.
- the second visit (day 7) : a follow-up visit will be performed by a member of the investigating team who will perform a second blood sample to all the participants to the study. The investigator will complete a second paper CRF with the participants to document any unwanted effects which may have occurred during the seven days between the inclusion visit and the follow-up visit.
- Conditions
- Rabies
- Being tested
- rabies vaccine
- Keywords
- rabies, vaccine, Post-exposure prophylaxis, Persistent immunity, Short protocol
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rabies vaccineBiological
- day 0 : questionnaire, blood sampling and vaccine booster (a single session of two intradermal doses of 0.1 mL)
- day 7 : questionnaire and blood sampling
| Study group | Role | What they receive |
|---|---|---|
| subjects who received three vs. four ID PEP at least two, five or 10 years earlier | Other | * 30 subjects who received three ID PEP at least two years earlier in Cambodia
* 30 subjects who received three ID PEP at least five years earlier in Cambodia
* 30 subjects who received three ID PEP at least 10 years earlier in Cambodia
* 30 subjects who received four ID PEP at least two years earlier in Madagascar
* 30 subjects who received four ID PEP at least five years earlier in Madagascar
* 30 subjects who received four ID PEP at least 10 years earlier in Madagascar Receives: Biological: rabies vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody titers measured (FAVN, RFFIT) and cellular immunity markers one week after a single session of ID rabies vaccine boosting in the two groups
Absence of statistically significant difference between antibody titers Fluorescent Antibody Virus Neutralization test (FAVN) and Rapid Fluorescent Foci Inhibition Test (RFFIT) and cellular immunity markers one week after a single session of ID rabies vaccine boosting in persons who have received a 3 sessions/1 week vs. 4 sessions/ 1 month ID PEP at least 2, 5 or 10 years earlier.
Measured: 1 year
Secondary outcomes (2)
Antibody titers measured by FAVN and RFFIT and immune response before a single session of ID rabies vaccine boosting in the two groups
Equivalence of antibody titers and immune response before a single session of ID rabies vaccine boosting in persons who have received a 3 sessions/1 week vs. 4 sessions/ 1 month ID PEP at least 2, 5 or 10 years earlier.
Measured: 1 year
Antibody titers measured by FAVN and RFFIT in all subjects for comparison
Equivalence of antibody titers measured using FAVN compared to the RFFIT used as reference.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start20 Oct 2021
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RabiesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- * 90 subjects in Cambodia or Madagascar who received ID PEP by 3 sessions/1 week at least two (30 subjects), five (30 subjects) or 10 years earlier (30 subjects), * 90 subjects in Cambodia or Madagascar who received ID PEP by 4 sessions/1 month at least two (30 subjects), five (30 subjects) or 10 years earlier (30 subjects),
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut Pasteur du Cambodge, Institut Pasteur de Madagascar
- Responsible party
- Sponsor
- Investigators
- Perrine Parize, MD, Study director, Institut Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829630
- Sponsor's protocol ID
- 2020-064
- Acronym
- RESIST-3
- Status last verified
- Nov 2021
- First submitted
- 31 Mar 2021
- Last updated
- 9 Mar 2023
- 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 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunity Persistence After Abridged Intradermal Rabies PEP
- ClinicalTrials.gov ID
- NCT04829630
- Acronym / sponsor ID
- RESIST-3 / 2020-064
- Conditions
- Rabies
- Keywords
- rabies, vaccine, Post-exposure prophylaxis, Persistent immunity, Short protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Institut Pasteur du Cambodge, Institut Pasteur de Madagascar
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 2 Apr 2021 (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.
After exposure, rabies can be prevented in almost 100% of cases by the administration of sufficient and timely post-exposure prophylaxis (PEP). PEP is based on wound cleansing, antisepsis, administration of rabies vaccine as well as rabies immunoglobulin, if reviewed. However, anti-rabies PEP remains too often out of financial and / or geographic access, especially for poor and / or rural populations in endemic countries who remain the most exposed to the risk of contracting rabies. Two major studies planned in Cambodia between 2014 and 2018 - the RESIST 0/1 clinical - epidemiological study and the RESIST-2 study on the antibody response to the vaccine - provided the basis that allowed a change in international recommendations on PPE. Since April 2018, the new "IPC protocol" of three sessions of reduced double doses (0.1 mL x 2) administered intradermally (ID) over one week has replaced the already very effective "TRC protocol" of four sessions over one month which was the reference dose-sparing protocol for endemic countries until 2018. It remains to be determined whether the IPC protocol (3 sessions / 1 week) confers long-term immunity equivalent to that obtained after a TRC ID protocol (4 sessions / 1 month). This question is of importance to public health decision-makers and clinical teams in endemic countries who would hesitate to switch to the abbreviated IPC protocol.
Detailed description
This is a multicenter, randomized, non-inferior clinical trial with samples for examinations and vaccination booster.
To achieve this study, persons who previously received PEP and of any age (including children), gender or medical condition (including pregnant women) and whichever the status of the dog which bit at least 2, 5 or 10 years ago will be contacted and invited to participate to the study.
This study will take place in two centers :
- The rabies prevention center at Institut Pasteur du Cambodge
- The rabies prevention center at Institut Pasteur de Madagascar. The study will be coordinated by Institut Pasteur in Paris which will subsequently conduct the analysis in collaboration with researchers at Institut Pasteur du Cambodge and Institut Pasteur de Madagascar.
This study will take place in two visits :
- the first visit (day 0) : after receiving consent from the participants, the member of the investigating team will perform the blood sample, followed by a single session of two intradermal doses of 0.1 mL. The investigators will also carry out measurements and complete the questionnaire with the participant.
- the second visit (day 7) : a follow-up visit will be performed by a member of the investigating team who will perform a second blood sample to all the participants to the study. The investigator will complete a second paper CRF with the participants to document any unwanted effects which may have occurred during the seven days between the inclusion visit and the follow-up visit.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- * 90 subjects in Cambodia or Madagascar who received ID PEP by 3 sessions/1 week at least two (30 subjects), five (30 subjects) or 10 years earlier (30 subjects), * 90 subjects in Cambodia or Madagascar who received ID PEP by 4 sessions/1 month at least two (30 subjects), five (30 subjects) or 10 years earlier (30 subjects),
| Arm | Type | Receives |
|---|---|---|
| subjects who received three vs. four ID PEP at least two, five or 10 years earlier | Other | Biological: rabies vaccine* 30 subjects who received three ID PEP at least two years earlier in Cambodia * 30 subjects who received three ID PEP at least five years earlier in Cambodia * 30 subjects who received three ID PEP at least 10 years earlier in Cambodia * 30 subjects who received four ID PEP at least two years earlier in Madagascar * 30 subjects who received four ID PEP at least five years earlier in Madagascar * 30 subjects who received four ID PEP at least 10 years earlier in Madagascar |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- person Identified in IP Cambodia or IP Madagascar records for having received ID PEP by 4 sessions/1 month or 3 sessions/1 week at least two, five or 10 years earlier, with no rabies boosting since that time;
- person Who received information adapter to his/her age and who signed the consent form (or his/her legal tutors)
Key exclusion criteria (2 listed)
- person who received Rabies vaccine booster since the earlier PEP
- person with allergy or other severe unwanted effect at the time of the earlier PEP
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 |
|---|---|---|
| rabies vaccine* day 0 : questionnaire, blood sampling and vaccine booster (a single session of two intradermal doses of 0.1 mL) * day 7 : questionnaire and blood sampling | Biological | subjects who received three vs. four ID PEP at least two, five or 10 years earlier |
Primary outcome
Antibody titers measured (FAVN, RFFIT) and cellular immunity markers one week after a single session of ID rabies vaccine boosting in the two groups
Time frame: 1 year
Absence of statistically significant difference between antibody titers Fluorescent Antibody Virus Neutralization test (FAVN) and Rapid Fluorescent Foci Inhibition Test (RFFIT) and cellular immunity markers one week after a single session of ID rabies vaccine boosting in persons who have received a 3 sessions/1 week vs. 4 sessions/ 1 month ID PEP at least 2, 5 or 10 years earlier.
2 secondary outcomes
Antibody titers measured by FAVN and RFFIT and immune response before a single session of ID rabies vaccine boosting in the two groups
Time frame: 1 year
Antibody titers measured by FAVN and RFFIT in all subjects for comparison
Time frame: 1 year
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 9 Mar 2023.
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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.
Perrine Parize, MD study director
Institut Pasteur
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rabies vaccine in people with Rabies, run by Institut Pasteur at 2 sites in 2 countries.
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 2 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 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Cambodia, Madagascar. 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?
Antibody titers measured (FAVN, RFFIT) and cellular immunity markers one week after a single session of ID rabies vaccine boosting in the two groups (time frame: 1 year). 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 9 Mar 2023.