An interventional study of rabies vaccine in Rabies, sponsored by Institut Pasteur. Completed at 2 sites in 2 countries. Per ClinicalTrials.gov, last updated 2023-03-09.
Sponsored by Institut Pasteur · Not applicable, Interventional, and Other
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.
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 :
This study will take place in two visits :
Exclusion Criteria:
* 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
Biological: 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
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.
Time frame: 1 year
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.
Time frame: 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.
Time frame: 1 year
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Institut Pasteur