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

NCT06433440 | Completed Phase 4 DMC

• 1 other identifier: PVRV-ID
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Rabies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To evaluate the safety of PVRV administered intradermally and intramuscularly based on the frequency of adverse drug events

  42 days

Study Arms (2)

Group-1

EXPERIMENTAL

0.2 ml of PVRV Intradermally (ID) on the following days: Day0, Day3, and Day7 Biological: PVRV PEP regimen

Biological: PVRV

Group-2

EXPERIMENTAL

0.5 ml of PVRV Intramuscularly (IM) on the following days: Day0, Day3, and Day7, Day14 and Day28 Biological: PVRV PEP regimen

Biological: PVRV

Interventions

PVRV BIOLOGICAL

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.

Group-1; Group-2

Eligibility Criteria

• Age: 2 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Peshawar: lead
• Hayatabad Medical Complex: collaborator

Study Sites (1)

Mohammad Ismail

Peshawar, KPK, 25000, Pakistan

Location

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Mohammad Ismail, PhD

  Department of Pharmacy, University of Peshawar

  STUDY CHAIR

• Waqar Ali, MPhil

  Department of Pharmacy University of Peshawar

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Mohammad Ismail Associate Professor of Clinical Pharmacy

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 29, 2024
• Study Start: July 1, 2020
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)