Immunogenicity and Safety Study of A New Chromatographically Purified Vero Cell Rabies Vaccine With ID Regimen and ERIG
Summary
A comparative,randomized (1:1)study to evaluate the safety and immunogenicity of a new chromatographically purified vero cell rabies vaccine (SPEEDA) and chromatographically purified vero cell rabies vaccine (SPEEDA)which is filled by Queen Saovabha Memorial Institute (TRCS SPEEDA)vs. reference vaccine (purified vero cell vaccine; VERORAB)when using with post-exposure rabies intradermal vaccination with or without equine rabies immunoglobulin.
Description
Rabies is an important world health problem especially in developing countries.Although the case-fatality ratio of human rabies is 100%,the disease is preventable by the modern cell-culture vaccine and rabies immunoglobulin.Post-exposure rabies vaccination with the modified Thai Red Cross intradermal(modified TRC-ID)regimen has been approved by WHO and proven to be immunogenic and effective. It represents a significant saving in vaccine cost and is now established in several developing countries. SPEEDA,chromatography purified vero cell derived rabies vaccine,approved by Thai FDA on 8 April 2009 and drug registration code of SPEEDA is 1C 90022/51. This study has a goal to determine the immunogenicity and safety of SPEEDA and TRCS-SPEEDA (SPEEDA which is filled by Queen Saovabha Memorial Institute)vs. reference vaccine (purified vero cell vaccine; VERORAB)when using with post-exposure rabies intradermal vaccination with or without equine rabies immunoglobulin.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Conditions
Rabies
Intervention
SPEEDA and TRCS SPEEDA
Location
Queen Saovabha Memorial Institute
Bangkok
Thailand
10330
Status
Not yet recruiting
Source
Queen Saovabha Memorial Institute
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01137045
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:13:10-0400
Clinical Trials
Effect of ERIG Injection on Day 7 After First Dose of Rabies Vaccination to Rabies Immune Response
No study was conducted to evaluate the rabies neutralizing antibody titers after RIG injection on day 7. The only study that has supported the delay of RIG administration was done in 1996 ...
A single center, prospective cohort, open-label study of rabies post exposure program with equine rabies immunoglobulin (ERIG) and purified chick-embryo cell (PCEC) rabies vaccine in WHO c...
The primary purpose of this study is to confirm the safety of KamRAB (Human Rabies Immunoglobulin) in children ages 0 months to
Rabies Immune Plasma Booster Study
Rabies immune globulin is a product that is lifesaving to unvaccinated individuals exposed to the rabies virus. Rabies immune globulin is made from plasma from immune donors. Currently the...
Immunogenicity and Safety of Verorab™ in Indian Population
- To demonstrate that rabies vaccine administered according to the Thai Red Cross, (TRC)-ID regimen (2-2-2-0-1-1) is not inferior to rabies vaccine administered according to the...
PubMed Articles
Segmentation of the rabies virus genome.
We established a system for the recovery of a segmented recombinant rabies virus, the virus genome RNA of which was divided into two parts: segment 1 encoding the nucleoprotein, phosphoprotein, matrix...
Spatiotemporal epidemic models for rabies among animals.
Rabies is a serious concern to public health and wildlife management worldwide. Over the last three decades, various mathematical models have been proposed to study the transmission dynamics of rabies...
Bat rabies surveillance and risk factors for rabies spillover in an urban area of Southern Brazil.
Bat rabies surveillance data and risk factors for rabies spillover without human cases have been evaluated in Curitiba, the ninth biggest city in Brazil, during a 6-year period (2010-2015). A retrospe...
Rabies is a lethal, but vaccine preventable disease. Vaccination uptake is however hampered by the time-consuming three-dose, 21/28-day schedule. The aim of this study was to examine whether adequate ...
Rabies is a zoonotic viral disease that can affect all mammals. In the United States, the majority of human rabies cases are caused by bats, which are the only known reservoirs for rabies virus (RABV)...
Medical and Biotech [MESH] Definitions
Rabies Vaccines
Vaccines or candidate vaccines used to prevent and treat RABIES. The inactivated virus vaccine is used for preexposure immunization to persons at high risk of exposure, and in conjunction with rabies immunoglobulin, for postexposure prophylaxis.
Lyssavirus
A genus of the family RHABDOVIRIDAE that includes RABIES VIRUS and other rabies-like viruses.
Rabies Virus
The type species of LYSSAVIRUS causing rabies in humans and other animals. Transmission is mostly by animal bites through saliva. The virus is neurotropic multiplying in neurons and myotubes of vertebrates.
Rhabdoviridae Infections
Virus diseases caused by RHABDOVIRIDAE. Important infections include RABIES; EPHEMERAL FEVER; and vesicular stomatitis.
Rabies
An acute infectious disease of the central nervous system affecting almost all mammals, including humans. It is caused by a rhabdovirus and usually spread by contamination with virus-laden saliva of bites inflicted by rabid animals. Important animal vectors include the dog, cat, vampire bat, mongoose, skunk, wolf, raccoon, and fox. (From Dorland, 27th ed)
