Clinical trial NCT06433440: Safety and Immunogenicity of Purified Verocell Rabies Vaccine PVRV Administered Intramuscularly and Intradermally
Official title: An Open-label, Randomized Study Evaluating the Safety and Immunogenicity of the Purified Vero Cell Rabies Vaccine PVRV Administered Intradermally and Intramuscularly as Post-exposure Prophylaxis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rabies
Lead sponsor: University of Peshawar
Sponsor class: OTHER
Collaborators: name: Hayatabad Medical Complex
First posted: 2024-05-29
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 76
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the clinical efficacy of PVRV administered intradermally vs intramuscularly based on immune response.
timeFrame: 56 days
Secondary outcomes:
measure: To evaluate the safety of PVRV administered intradermally and intramuscularly based on the frequency of adverse drug events
timeFrame: 42 days
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Mohammad Ismail
state: KPK
Study officials:
affiliation: Department of Pharmacy, University of Peshawar
name: Mohammad Ismail, PhD
role: STUDY_CHAIR
affiliation: Department of Pharmacy University of Peshawar
name: Waqar Ali, MPhil
role: STUDY_DIRECTOR
References: