Non Inferiority Trial of Locally Manufactured Rabies Vaccine 'Rabix-VC' in Bangladesh

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Rabies is a viral infectious disease of mammals including humans. Early symptoms of rabies include fever and tingling at the site of exposure, followed by one or more symptoms such as fear of water, violent movements, confusion, uncontrolled excitement, inability to move parts of the body, and loss of consciousness. Once symptoms of the disease develop, rabies is invariably fatal. It is one of the oldest human diseases. It continues to be a major public health problem in developing countries. Rabies is the 10th biggest cause of death due to infectious diseases worldwide. Rabies is endemic in Bangladesh with high public health significance and ranked third highest among rabies-endemic countries for human rabies deaths. In Bangladesh, an estimated 200 000 animal bite cases with more than 2000 human rabies deaths are reported annually. Most importantly, most of the victims are children below 15 years old coming from poor rural communities.

Rabies is a vaccine-preventable viral disease and is highly effective when given pre- or post-exposure to a bite from a potentially rabid animal. Currently there is no locally manufactured Rabies vaccine available in Bangladesh. The results of this study will provide information regarding the immunogenicity and safety of the locally manufactured Rabies vaccine 'Rabix VC' as a test vaccine using 'Rabipur' as a comparator vaccine in a non inferiority study design.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Immunogenicity of ID vs IM Rabies Vaccine

NCT07345208

Rabies

NOT_YET_RECRUITING PHASE2/PHASE3

A Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried

NCT07021703

Rabies

RECRUITING PHASE1

Safety and Tolerability of CV8102 Alone and in Combination With a Rabies Virus Vaccine in Healthy Adults

NCT02238756

Rabies

COMPLETED PHASE1

Clinical Trial of Freeze-dried Human Rabies Vaccine (Human Diploid Cells)

NCT07028801

Rabies

NOT_YET_RECRUITING PHASE3

Immunogenicity and Safety of Different Dosages of Rabies Vaccine (Serum-free Vero Cell)

NCT07055880

Rabies

NOT_YET_RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This will be a randomized, controlled, double-blind, parallel design, comparative, non-inferiority study on a total of 440 healthy adult participants (18-75 years of age). Participants who will be eligible for the study, will be invited to participate in the study. The study will be conducted in four groups. In One Comparator group, 110 participants will receive Rabipur through Intramuscular Route, in Test group, 110 participants will receive Rabix VC through Intramuscular Route. In another Comparator group, 110 participants will receive Rabipur through Intradermal Route and Test group, 110 participants will receive Rabix VC through Intradermal Route. Total 220 participants will receive Rabix VC (Test Group) and 220 participants will receive Rabipur (Comparator Group), 1.0 ml through Intramuscular Route and 0.2 ml through Intradermal Route, (0.1 ml each arm) respectively.

Informed consent will be obtained from the participants. Only participants who give voluntary consent will be enrolled in the study. The potential risk and the procedures to be carried out are mentioned in the consent form. Compensation will include transportation costs for the participants. Participants only can decide whether they will participate in the study. They will also be able to withdraw their name from the study at any time, without giving any explanation, and will be able to refuse collection of any or all laboratory samples for the study.

Participants may not directly benefit from participating in the study; however, results obtained from this study will be useful in understanding of potential antigenic components for designing an effective Shigella vaccine and may thus benefit the society. The whole study period for each individual will be 90 days. Specimen collection and interview will be carried out 9-10 (maximum) times including enrollment and it will take around 30 minutes per visit.

After taking consent from participants, they will be asked to do the following: Blood (10-12 ml for adults) specimens will be collected at screening (day -7 to -2), day 14 and day 30 or day 44. For Intramuscular group vaccination schedule will be on day 0, day 7, day 21 and day 0, day 3, day 7, day 28 for intradermal group. Also, there will be additional follow up on day 60 and final visit on day 90.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non Inferiority Trial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Test Group for intramuscular route

110 adult participant will get Ravix-VC

Group Type EXPERIMENTAL