## Protocol Section
### Identification Module
**NCT ID:** NCT06433440

**Brief Title:** 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

#### Organization Study ID Info
**ID:** PVRV-ID
#### Organization
**Class:** OTHER
**Full Name:** University of Peshawar
### Status Module
#### Completion Date
**Date:** 2021-08-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-08-30

**Type:** ACTUAL

#### Start Date
**Date:** 2020-07-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Hayatabad Medical Complex

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Peshawar

#### Responsible Party

**Investigator Affiliation:** University of Peshawar

**Investigator Full Name:** Mohammad Ismail

**Investigator Title:** Dr. Mohammad Ismail Associate Professor of Clinical Pharmacy

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Rabies

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 100

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 0.2 ml of PVRV Intradermally (ID) on the following days: Day0, Day3, and Day7

Biological: PVRV

PEP regimen

**Intervention Names:**

- Biological: PVRV

**Label:** Group-1

**Type:** EXPERIMENTAL

#### Arm Group 2

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

Biological: PVRV

PEP regimen

**Intervention Names:**

- Biological: PVRV

**Label:** Group-2

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group-1

- Group-2

**Description:** 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.

**Name:** PVRV

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** To evaluate the clinical efficacy of PVRV administered intradermally vs intramuscularly based on immune response.

**Time Frame:** 56 days

#### Secondary Outcomes

**Description:** 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.

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

**Time Frame:** 42 days

### Eligibility Module

**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

**Maximum Age:** 76 Years

**Minimum Age:** 2 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Peshawar

**Country:** Pakistan

**Facility:** Mohammad Ismail

**State:** KPK

**Zip:** 25000

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Pharmacy, University of Peshawar

**Name:** Mohammad Ismail, PhD

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** Department of Pharmacy University of Peshawar

**Name:** Waqar Ali, MPhil

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** Will be shared on reasonable request from the PI

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000018353

- Term: Rhabdoviridae Infections

- ID: D000018701

- Term: Mononegavirales Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000007239

- Term: Infections

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M14667

- Name: Rabies

- Relevance: HIGH

- As Found: Rabies

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20491

- Name: Rhabdoviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M20778

- Name: Mononegavirales Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: T4859

- Name: Rabies

- Relevance: HIGH

- As Found: Rabies

### Condition Browse Module - Meshes

- ID: D000011818

- Term: Rabies

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
