Safety and Immunogenicity of ID vs IM Rabies Vaccine

NCT07345208 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: PR-25035
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Burden: Rabies is a viral zoonotic disease that is 100% fatal if left untreated. Globally, Bangladesh is ranked third in terms of rabies infections. In 2009, the estimated human fatality from rabies in Bangladesh surpassed 2,000. However, the death toll has steadily declined to 26 in 2020, owing to the implementation of the 'National Rabies Elimination Program' beginning in 2010, which included the introduction of the cell culture vaccine. Though this infection is entirely preventable by vaccination, the available intramuscular regimen is costly and requires multiple high doses. Knowledge gap: The safety and immunogenicity of an intradermal rabies vaccine regimen in the Bangladeshi population needs to be assessed to comply with the recommendation of DGDA to obtain approval to be administered through an alternate route. Relevance: Intradermal rabies vaccine administration is a safe method that reduces the amount of vaccine needed and the number of doses required by producing immunogenicity similar to that of the intramuscular regimen. This translates to 60-80% cost reductions while preserving the safety and immunogenicity of the vaccine. The intramuscular rabies vaccine by Popular Pharmaceuticals PLC has already been granted marketing authorization by DGDA. However, the vaccine's administration via the intradermal route is yet to receive approval from DGDA for marketing as per the regulatory requirements. Hypothesis: The immunogenicity and safety of the Intradermal rabies vaccine (Popular Pharmaceutical PLC) will be non-inferior to the intramuscular regimen of the same vaccine. Objectives:

• A seroconversion level of 0.5 IU/ml or more when tested for Rabies Virus Neutralizing Antibody (RVNA) following intradermal vaccination by Popular Pharmaceuticals PLC. during the study period
• Non-inferior safety parameters of the intradermal rabies vaccine regimen in comparison with the available intramuscular regimen by Popular Pharmaceuticals PLC.

Conditions

Rabies

Keywords

pre-exposure prophylaxis; intradermal; rabies vaccine; clinical trial; intramuscular; safety; immunogenicity; non-inferiority

Outcome Measures

Primary Outcomes (1)

• Seroconversion Rate

  Rabies Virus Neutralizing Antibody: ≥ 0.5 IU/mL

  14 days, 28 days, and 180 days following the completion of vaccination doses

Secondary Outcomes (4)

• Number of participants with treatment-related serious adverse events as assessed by CTCAE v5.0

  Participants will be followed up 14 days, 28 days, and 180 days following the completion of vaccination doses. They will also contact the research team for self-reporting of adverse events.

• Number of participants with post-vaccination laboratory abnormalities

  The number of participants with post-vaccination laboratory values will be assessed on day 21 and day 187 of the study.

• Number of participants with post-vaccination abnormalities in vital signs

  Vital signs will be evaluated on the day of check-in (day 0), day 7, and during post-vaccination follow-up (day 21, 35, and 187); 30 minutes before dosing on vaccination days

• Number of participants with post-vaccination abnormalities found in physical examination

  General and systematic examination will be conducted on check-in (Day 0), day 7, and during post-vaccination follow-up (Days 21, 35, and 187) and

Study Arms (2)

Test Arm-1

EXPERIMENTAL

0.2 ml (0.1 ml in both deltoid regions) Inj. Rabivax ID/SC via the intradermal (ID) route

Biological: Rabies vaccine

Reference Arm-2

ACTIVE COMPARATOR

1 ml (in the deltoid region of one arm) inj. Rabivax IM via the intramuscular (IM) route.

Biological: Rabies vaccine

Interventions

Rabies vaccine BIOLOGICAL

The intradermal rabies vaccine is designed to elicit an immune response in the skin. The skin is composed of three layers, from outermost to innermost: the epidermis, dermis, and hypodermis, where the dermis is further divided into two sub-layers: the superficial papillary dermis and the deeper reticular dermis. The papillary dermis is 100-300 μm thick and is the target layer for ID immunization. This layer is rich in antigenpresenting cells (APCs), including dermal dendritic cells (DDCs) and Langerhans cells. DDCs capture antigens in the dermis and migrate to the regional lymph nodes, which present antigens to T-cells, triggering their activation. Soluble antigens also migrate to lymph nodes, leading to the activation of B-cells. Because of the high concentration of APCs in the dermis, ID delivery of reduced antigen doses (typically 20% to 30% of the standard amount) can elicit immune responses comparable to those achieved with standard doses administered intramuscularly.

Also known as: inj. Rabivax ID/SC

Test Arm-1

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers aged \>4 years
• Able to comply with the research process and provide informed consent
• Able to attend all the scheduled visits and comply with the trial procedures
• Medical history and clinical examination demonstrating that the subject is healthy
• Women willing to follow any method of contraception throughout the duration of the study.

You may not qualify if:

• Subjects participating in other clinical trials in the 4 weeks preceding the first trial vaccination dose
• Subjects with a history of previous rabies vaccination (either pre- or post-exposure prophylaxis)
• Subjects with a history of receiving Rabies immunoglobulin (Ig (human/equine) prior to the study
• Subjects with a fever (≥37.2°C) or any moderate or severe acute illnesses or active infections on the day of vaccination
• History of systemic hypersensitivity to any component included in the vaccine or a history of adverse events as a reaction to previous experimental vaccine studies
• History of receiving any immunoglobulin, blood, or blood-based product in the last 3 months or planning to donate blood in the following 3 months, which may interfere with the immune response
• Screened as positive for HBsAg, Anti-HCV, and anti-HIV
• Subjects receiving any vaccine at least 4 weeks prior to enrolment or expected to receive any vaccine 4 weeks after the administration of the trial vaccine.
• Lactating women or pregnant women as detected by the urine hCG strip test.
• History of alcohol or any substance abuse (benzodiazepines, methamphetamines, opioids, cannabinoids, cocaine, barbiturates) within 1 year
• Subjects with congenital or acquired immunodeficiency or subjected to short- or long-term corticosteroid or immunosuppressive therapy
• Thrombocytopenia, bleeding disorders, or anticoagulants used during the 3 weeks prior to trial vaccination to avoid intramuscular haemorrhage
• Any major psychiatric disorder such as schizophrenia, major depressive disorder, severe anxiety disorder, etc.
• History of cardiac arrhythmias, such as bradycardia, tachycardia, supraventricular tachycardia (SVT), ventricular tachycardia (VT), ventricular fibrillation (VF), atrial fibrillation (AF), etc., as assessed by the electrocardiogram report
• History of renal insufficiency or dialysis

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Popular Pharmaceuticals PLC.: collaborator

Study Sites (1)

Infectious Disease and Tropical Medicine Department (Surya Kanta Hospital), Mymensingh Medical College Hospital, Mymensingh

Mymensingh, 2200, Bangladesh

Location

Related Publications (3)

• World Health Organization. WHO guidelines on non-clinical evaluation of vaccines, Annex 1, TRS No 927

  BACKGROUND

• World Health Organization. WHO Expert Consultation on Rabies: WHO TRS N°1012. 2018

  BACKGROUND

• Guideline for Animal Bite Management in Bangladesh 2021

  BACKGROUND

MeSH Terms

Conditions

Rabies

Interventions

Rabies Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Shomik Maruf, MSc

  International Center for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shomik Maruf, MSc

CONTACT

+8801673587409; shomik.maruf@icddrb.org

Soumik Kha Sagar, MPH

CONTACT

+8801738766601; soumik.sagar@icddrb.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Since we already have an established intramuscular vaccine regimen for Rabies, we have chosen to follow a randomized, single-blinded, non-inferiority trial to assess the immunogenicity of the intradermal Rabies vaccine.

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: January 15, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)