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

NCT06433440 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-05-29

No results posted yet for this study

Summary

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).

Conditions

  • Rabies

Interventions

BIOLOGICAL

PVRV

Group-1 will receive PVRV ID on on the following days: Day0, Day3, Day7, while group-2 will receive PVRV IM on Day0, Day3, Day7, Day14, and Day28.

Sponsors & Collaborators

  • Hayatabad Medical Complex

    collaborator OTHER_GOV

  • University of Peshawar

    lead OTHER

Principal Investigators

  • Mohammad Ismail, PhD · Department of Pharmacy, University of Peshawar

  • Waqar Ali, MPhil · Department of Pharmacy University of Peshawar

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
76 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2021-08-30
Completion
2021-08-30

Countries

  • Pakistan

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 NCT06433440 on ClinicalTrials.gov