CompletedPhase 4

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

Pakistan100 participantsStarted 2020-07-01

Plain-language 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).

Who can participate

Age range2 Years – 76 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

To evaluate the clinical efficacy of PVRV administered intradermally vs intramuscularly based on immune response.

Timeframe: 56 days

Trial details

NCT IDNCT06433440

SponsorUniversity of Peshawar

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-30

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