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

Rabies Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06433440
• Other study ID #: PVRV-ID
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2020
• Est. completion date: August 30, 2021

Study information

• Verified date: May 2024
• Source: University of Peshawar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 76 Years

Eligibility

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

Related Conditions & MeSH terms

• Rabies

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Mohammad Ismail	Peshawar	KPK

Sponsors (2)

Lead Sponsor	Collaborator
University of Peshawar	Hayatabad Medical Complex

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	56 days
Secondary	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.	42 days