Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433440
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2024-05-13
Brief Title:
Safety and Immunogenicity of Purified Verocell Rabies Vaccine PVRV Administered Intramuscularly and Intradermally
Sponsor:
University of Peshawar
Organization:
University of Peshawar
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None