Immunity Persistence After Abridged Intradermal Rabies PEP

2020-064

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.

2021-10-20

2023-02-01

2023-02-01

Completed

180

Inclusion Criteria: * 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) Exclusion Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '* 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),\n* 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),', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 180, 'type': 'ACTUAL'}}

2023-03-09