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Rabies clinical trials

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NCT ID: NCT05702008 Completed - Rabies Clinical Trials

Social Media as an Information, Education and Communication Tool for Rabies Prevention: An Interventional Study

Start date: July 1, 2022
Phase: N/A
Study type: Interventional

Background: Rabies is a fatal disease that can be avoided by treating animal bites promptly. Hence, post-exposure prophylaxis is critical. As a result, the National Rabies Control Program was approved under the 12th five-year plan in India. One of its strategies is to engage in Information, Education and Communication activities. Social media provides an opportunity for the quick and easy dissemination of research but is constrained by a lack of peer review and the risk of misinterpretation. The efficacy of a novel social media-based knowledge dissemination strategy for rabies prevention was tested in this study. Methods: An experimental study design was followed, wherein 144 preclinical medical students of Maulana Azad Medical College, Delhi, India were included in each control and test group. The test group was administered the intervention, which exposed the participants to health education material via social media across a span of 30 days. Participants' knowledge, attitude and practices were observed before and after the study duration.

NCT ID: NCT05684185 Completed - Clinical trials for Rabies Post-exposure Prophylaxis

Immunogenicity Assessment of Subjects Receiving Rabies Post-exposure Prophylaxis in Cambodia

Start date: July 15, 2020
Phase:
Study type: Observational

A rabies virus neutralizing antibody (RVNA) concentration ≥ 0.5 IU/ml at 14 days after immunization is considered a proxy for protection in vaccine efficacy studies. Abridged and dose-sparing vaccination regimens increase accessibility and reduce both direct and indirect costs, especially in resource-constrained countries where RABV prevalence is highest. Several efficacy studies evaluated safety and immunogenicity of abridged regimens in healthy adult volunteers using either four-site intradermal (ID) or intramuscular (IM) regimens, showing them to be safe and immunogenic. Researchers at the Institut Pasteur du Cambodge (IPC) have previously conducted a retrospective study on clinical outcome at ≥6 months in 3318 Cambodians who received intradermal Vero cell vaccine post-exposure prophylaxis after a bite by a rabid or sick-looking but untested dog in 2003-2014. Here, the investigators could show that there was no significant difference in survival among patients who received 3 versus 4 sessions of the Thai Red Cross (TRC) ID regimen. In a separate study, investigators measured antibody responses in order to evaluate the immunogenicity of the TRC regiment after 3 sessions versus 4 sessions. The investigators did not observe an increase in rabies virus seroneutralization titers 14 days after the fourth immunization compared to 14 days after the third immunization. These results contributed to changes endorsed by the WHO in its April 2018 guidelines. The "Institut Pasteur du Cambodge (IPC) regimen" of three PEP sessions of two-site ID 0.1 mL vaccine doses each at days 0, 3 and 7 is the first one-week PEP regimen to be recommended. In the current research project, the aim is to compare further different PEP vaccination strategies in a real life setting of individuals attending the rabies vaccination center at Institut Pasteur du Cambodge (IPC) in Phom Penh, Cambodia. The antibody kinetics and cellular immune responses in patients following either the one-week, 2-site ID regimen (IPC regimen) or the two-week IM regimen (4-dose regimen) as well as the participants' survival for both protocols after 6 months are evaluated.

NCT ID: NCT05667974 Active, not recruiting - Prevention Clinical Trials

A Study to Evaluate a PIKA Rabies Vaccine(Vero Cell)for Human Use,Freeze-dried

Start date: September 22, 2023
Phase: Phase 3
Study type: Interventional

This is a phase III, randomized, comparator-controlled, double-blind, multicenter study to evaluate lot-to-lot consistency of three lots of a PIKA Rabies Vaccine, immunogenicity and safety in healthy adults using a post-exposure prophylaxis schedule. It is also the aim of this study to evaluate non-inferiority and superiority of the PIKA Rabies Vaccine compared to the rabies vaccine comparator ChiroRab.

NCT ID: NCT05549908 Completed - Rabies Human Clinical Trials

Vaccine Prevention of Rabies Adopts 4-shot Immunization Method

Start date: July 22, 2020
Phase: Phase 3
Study type: Interventional

A phase III clinical trial to evaluate the immunogenicity and safety of freeze-dried human rabies vaccine (Vero cell) developed by Changchun Zhuoyi Biological Co., Ltd. inoculated in a 4-dose procedure (2-1-1)

NCT ID: NCT05547815 Completed - Rabies Clinical Trials

Observation on the Immune Persistence of People Aged 10-60 Years Old Immunized With Five Doses of Rabies Vaccine

Start date: November 11, 2019
Phase: Phase 4
Study type: Interventional

Evaluation of immune persistence after rabies vaccination in 150 people.

NCT ID: NCT05545371 Enrolling by invitation - Rabies Human Clinical Trials

Prevention of Rabies With Four Doses of Rabies Vaccine

Start date: June 18, 2022
Phase: Phase 3
Study type: Interventional

To evaluate the non inferiority of the immunogenicity of the test vaccine inoculated according to the four dose immunization program over the five dose immunization program and the batches consistency of immunogenicity according to five dose immunization procedures.

NCT ID: NCT05453487 Recruiting - COVID-19 Clinical Trials

Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine (Sinopharm BBIBP-CorV) Coadministered With Rabies Vaccine

Start date: July 21, 2022
Phase: Phase 4
Study type: Interventional

Evaluation of immunogenicity and safety of inactivated COVID-19 vaccine (BBIBP-Cov) coadministered with rabies vaccine.

NCT ID: NCT05382650 Recruiting - Pediatrics Clinical Trials

Survey of Human Rabies Immune Globulin Safety in Children

Start date: February 22, 2023
Phase:
Study type: Observational

This observational study will be conducted across the Houston Methodist system, including all hospital-based and freestanding emergency departments (ED), and up to 4 additional sites in the United States. The safety of human rabies immune globulin (HRIG) 300 IU/mL product (HyperRAB®) in pediatric patients has not been fully established. The purpose of this study is to evaluate the safety of HRIG 300 IU/mL when given to pediatric patients per standard of care for rabies postexposure prophylaxis (PEP) in the ED.

NCT ID: NCT05350735 Completed - Rabies Clinical Trials

Phone Text Message Reminders on Compliance With Human Rabies Post Exposure Prophylaxis Project

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

Every year, rabies, a disease transmitted to humans by rabid dogs, is estimated to kill 59,000 people globally, mostly children 15 years and below in Africa and Asia. This is despite the availability of effective vaccines against rabies in humans, and in dogs. Following a dog bite, there are two critical steps required to prevent clinical disease and death: thorough wound washing with clean running water for at least 15 minutes; and immediate injection with anti-rabies vaccine on the day of being bitten followed by other four injections over the course of one month. Delay in seeking first dose of anti-rabies or failure to complete the recommended dosage may result in clinical rabies and death. The investigators proposed to assess the effect of short message system (SMS) phone text reminders sent to bite patients ahead of their scheduled visits on the adherence to scheduled anti-rabies doses among bite patients in rural eastern Kenya. The investigators enrolled bite patients presenting at Makueni County Referral Hospital between October 2018 and March 2019. Bite patients presenting to the facility between January and March 2019 received SMS reminder written in both English and local dialect a day before each dose of anti-rabies vaccine. These data were compared to those presenting to the health facility in the period prior (October to December 2018) before the introduction of the SMS reminder. This group received routine hospital cards as reminder of their next dose of anti-rabies vaccine injection. Each study participant was contacted after one month from the time of the bite and a phone interview completed to assess compliance and factors associated with completion of the five doses of anti-rabies vaccine.

NCT ID: NCT04852068 Active, not recruiting - Safety and Efficacy Clinical Trials

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

Start date: April 10, 2021
Phase: Phase 3
Study type: Interventional

This clinical trial is carried out in two phases. The first phase adopts an open design, and the second phase adopts a randomized, blinded, and similar vaccine-controlled non-inferiority trial design. The first stage: According to the order of two age groups of 18-60 years old and 10-17 years old, 40 cases were enrolled in each age group (20 persons for the 5-dose program and 20 for the 4-dose program). Subjects in the 5-dose group received 1 dose of test vaccine on 0, 3, 7, 14, and 28 days each. Subjects in the 4-dose group received 1 dose each on both arms on day 0, and 1 dose on day 7 and day 21 each. All subjects in the first stage were only observed for safety and were followed up to 6 months after the entire course of vaccination. The second stage: the total number of enrolled 2400 cases, 10-60 years old, the 4-dose program group and the 5-dose program group of the test vaccine, the 4-dose program group and the 5-dose program group of the control vaccine according to the random ratio 1:1:1:1. Among the total number of participants, 1680 cases (420 cases per group) were simultaneously observed for immunogenicity and safety, and the remaining 720 subjects (180 cases per group) only underwent safety observation. 800 subjects (200 cases in each group) received 6-month immune persistence observation after full vaccination, and 400 subjects in the test vaccine group received 12 months immune persistence observation after full vaccination. In the second stage, 1680 subjects were collected before the immunization, 7 days after the first dose, 14 days after the first dose, and 14 days after the full vaccination to test rabies virus antibodies to evaluate the immunogenicity of the test vaccine. 800 subjects were in the whole process Immune persistent blood sampling was performed 6 months after vaccination, and subjects in the test vaccine group were further subjected to immune persistent blood sampling 12 months after the full course of vaccination to evaluate immune durability. Collect all AEs within 30 minutes after each dose, AEs from 0-7 days, all non-collective AEs from the first dose to 30 days after the full course of vaccination, and all serious AEs from the first dose to 6 months after the full course of vaccination Adverse events.