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NOT YET RECRUITING

NCT07345208

PHASE2/PHASE3

Safety and Immunogenicity of ID vs IM Rabies Vaccine

Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh

View on ClinicalTrials.gov

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: 1. To compare the seroconversion level of the intradermal rabies vaccine to the intramuscular regimen by Popular Pharmaceuticals PLC. in healthy Bangladeshi individuals 2. To compare the safety of the intradermal rabies vaccine to the intramuscular regimen by Popular Pharmaceuticals PLC. in healthy Bangladeshi individuals Methods: This will be an open-label, non-inferiority, single-blinded, randomized controlled trial where the safety and immunogenicity of the intradermal rabies vaccine will be assessed compared with the standard intramuscular regimen, both by Popular Pharmaceuticals PLC., amongst healthy individuals. The study will be conducted at the Infectious Disease and Tropical Medicine Department (Surya Kanta Hospital), Mymensingh Medical College Hospital, Mymensingh. We will enroll 90 participants and randomly assign them to two equal groups: a test group and a reference group. The test groups will receive 0.2 ml Inj. Rabivax intradermally (0.1 ml in each arm), whereas the reference group will receive 1 ml Injectable Rabivax (2.5 IU/ml) intramuscularly. The participants will be followed up on days 21, 35, and 187 for clinical and biochemical evaluation. A comparative analysis of safety and immunogenicity will be conducted on intradermal and intramuscular administration based on the collected data. Outcome measures/variables: * 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.

Official title: An Open Label, Randomized Non-Inferiority Trial Comparing Safety and Immunogenicity of Intradermal Versus Intramuscular Administration of Registered Rabies Vaccine (by Popular Pharmaceuticals PLC.) in Healthy Bangladeshi Population

Key Details

Gender

All

Age Range

5 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-12-15

Completion Date

2027-07-15

Last Updated

2026-01-15

Healthy Volunteers

Yes

Conditions

Rabies

Interventions

BIOLOGICAL

Rabies vaccine

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.

BIOLOGICAL

Rabies vaccine

Rabies vaccine is an active immunizing agent used to prevent infection caused by the rabies virus. The vaccine works by causing the body to produce its own protection (antibodies) against the rabies virus.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 * Any immunosuppressive disorder, such as cancers, multiple myeloma (MM), various autoimmune diseases, etc. * Participants with clinically significant or abnormal laboratory parameters (serum creatinine, SGPT, AST, serum electrolytes) in the opinion of the investigator. * Any condition that presents an unacceptable risk of injury, as assessed by the site investigator * Subjects planning to have surgery in the 3 months preceding the completion of the project * Subjects concurrently using anti-malarial drugs * Any condition that, in the researcher's opinion, would jeopardize the safety or rights of the subject or prevent the subject from completing the procedures of the study protocol * Subjects exposed to any rabid animal bite in the 4 weeks preceding the commencement of the study. * Subjects with Type I or Type II Diabetes, as assessed by Random Blood Sugar level. * All research facility staff directly participating in this study, including their immediate family and relatives.

Locations (1)

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

Mymensingh, Bangladesh