Immunity Persistence After Abridged Intradermal Rabies PEP

NCT04829630 | Completed

• 1 other identifier: 2020-064
• Study Type: interventional
• Target: 180
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

rabies; vaccine; Post-exposure prophylaxis; Persistent immunity; Short protocol

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  1 year

• Antibody titers measured by FAVN and RFFIT in all subjects for comparison

  1 year

Study Arms (1)

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

Biological: rabies vaccine

Interventions

rabies vaccine BIOLOGICAL

* 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

subjects who received three vs. four ID PEP at least two, five or 10 years earlier

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Pasteur: lead
• Institut Pasteur du Cambodge: collaborator
• Institut Pasteur de Madagascar: collaborator

Study Sites (2)

Institut Pasteur du Cambodge

Phnom Penh, Cambodia

Location

Institut Pasteur de Madagascar

Antananarivo, BP 1274, Madagascar

Location

MeSH Terms

Conditions

Rabies

Interventions

Rabies Vaccines

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Perrine Parize, MD

  Institut Pasteur

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: * 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),

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 2, 2021
• Study Start: October 20, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: March 9, 2023

Record last verified: 2021-11

Locations

MA (1); CA (1)