A Phase 4 interventional study of PVRV in Rabies, sponsored by University of Peshawar. Completed at 1 site in Pakistan. Open to participants aged 2 Years to 76 Years. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by University of Peshawar · Phase 4, Interventional, and Prevention
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).
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.
114 studies on the registry are indexed under Rabies; 15 are open to participants now.
This study's enrollment of 100 is below the median of 201 across 104 interventional studies indexed under Rabies.
Browse Rabies studies →University of Peshawar is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
0.2 ml of PVRV Intradermally (ID) on the following days: Day0, Day3, and Day7 Biological: PVRV PEP regimen
Biological: PVRV
0.5 ml of PVRV Intramuscularly (IM) on the following days: Day0, Day3, and Day7, Day14 and Day28 Biological: PVRV PEP regimen
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.
To evaluate the clinical efficacy of PVRV administered intradermally vs intramuscularly based on immune response.
Patients were assigned into two groups each consisting of n=50 patients: Group-1 and Group-2. Group-1 were administered PVRV intradermally in a dose of 0.2ml on day 0, day 3, and day 7 as post exposure prophylaxis. While, patients in the group-2 received PVRV intramuscularly in a dose of 0.5ml on day 0, day 3, day 7, day 14 and day 28. Efficacy of PVRV in both groups were measured by the presence of rabies virus neutralizing antibodies (RVNA). Patients with an RVNA titer of ≥ 0.5 IU/mL were considered immunized.
Time frame: 56 days
To evaluate the safety of PVRV administered intradermally and intramuscularly based on the frequency of adverse drug events
Monitoring of both local and systemic adverse events occurring during the study period The safety of the PVRV was determined by reviewing ADEs obtained during physical examinations following vaccine administration and during follow-up visits in both the groups (group-1 and group-2). The ADEs were recorded after completion of the full vaccination schedule by following-up the patient until day 42. Adverse drug events were characterized in terms of local and systemic effects. A reaction was considered local when it occurred at the site of injection within a few hours of administration, while systemic effects were defined as those occurring in tissues distant from the site of contact between the body and vaccines.
Time frame: 42 days
Plan to share: No — Will be shared on reasonable request from the PI
No publications or documents are linked to this record.
Ran from Jul 2020 to primary completion in Aug 2021, 13 months.
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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