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Immunity Persistence After Abridged Intradermal Rabies PEP

NCT04829630 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2023-03-09

No results posted yet for this study

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. 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.

Conditions

  • Rabies

Interventions

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

Sponsors & Collaborators

  • Institut Pasteur du Cambodge

    collaborator OTHER

  • Institut Pasteur de Madagascar

    collaborator OTHER

  • Institut Pasteur

    lead INDUSTRY

Principal Investigators

  • Perrine Parize, MD · Institut Pasteur

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-20
Primary Completion
2023-02-01
Completion
2023-02-01

Countries

  • Cambodia
  • Madagascar

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04829630 on ClinicalTrials.gov