Safety and Immunogenicity of Purified Verocell Rabies Vaccine PVRV Administered Intramuscularly and Intradermally

University of Peshawar

Status and phase: Completed; Phase 4

Conditions: Rabies

Treatments: Biological: PVRV

Study type: Interventional

Funder types: Other

Identifiers

NCT06433440

PVRV-ID

Details and patient eligibility

About

Rabies is fatal disease but preventable with rabies vaccines and immunoglobulins, conventionally involves intramuscular (IM) administration of the vaccine. However, switching the intradermal (ID) route offers potential advantages in dosing, time and cost without compromising efficacy and safety. Therefore, this study aims to compare the safety and immunogenicity of a short-term three-doses intradermal regimen (3D-ID) with a conventional five-doses intramuscular regimen (5D-IM) of the purified Vero cell rabies vaccine (PVRV), administered via both intramuscular (IM) and intradermal (ID) routes as post-exposure prophylaxis (PEP).

Full description

Rabies vaccines can be used ID for PEP, according to a WHO Expert Committee recommendation. The administration of short-term PEP through ID (3-doses) offers a safe, immunogenic, dose-sparing, and cost-effective alternative to the conventional protocol (IM, 5-dose regimen) while reducing the volume by up to 60 to 80% and vaccination schedules by 3 weeks. This strategy has the potential to reduce the overall requirement and cost of such vaccines, along with minimizing the burden on healthcare professionals and facilities. Furthermore, this strategy is more likely to improve vaccination compliance compared to conventional protocol, and will certainly improve treatment outcomes.

Enrollment: 100 patients

Sex: All

Ages: 2 to 76 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants aged 2 year or older
• Both male and female
• Dog-bite cases only
• Informed consent form signed by the individual participant and/or their parents or guardian in case of minor age or major Trauma

Exclusion criteria

• Subject is participating in any other clinical trial.
• Pregnant and lactating women
• Have a plan to donate blood while participating in the study
• Received any other vaccine except rabies vaccines in last 6 months

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Group-1

Experimental group

Description:

0.2 ml of PVRV Intradermally (ID) on the following days: Day0, Day3, and Day7 Biological: PVRV PEP regimen

Treatment:

Biological: PVRV

Group-2

Experimental group

Description:

0.5 ml of PVRV Intramuscularly (IM) on the following days: Day0, Day3, and Day7, Day14 and Day28 Biological: PVRV PEP regimen

Treatment:

Biological: PVRV