Rabies treatment proved safe and effective for use in children in the first pediatric trial

A treatment known as KEDRAB (rabies immunoglobulin) [Human]), Currently used to prevent rabies and has proven to be safe and effective for patients under the age of 17.

Results announced today Human vaccine and immunotherapy Report the first and only human pediatric trial Rabies Immunoglobulin (HRIG) currently available in the United States. The findings were submitted to the US Food and Drug Administration for review.

In the United States, every 10 minutes someone is receiving treatment that can expose them to rabies. Globally, the World Health Organization (WHO) estimates that rabies causes 59,000 deaths annually in more than 150 countries, with 95% of cases occurring in Africa and Asia, but rabies is a disease. We admit that we are likely to significantly underestimate the true burden of.

WHO also estimates that 40% of the world’s burden of rabies occurs in children under the age of 15, and most encounters with this disease follow dog bites.

If clinical symptoms appear; rabies is virtually 100% deadly.

The current treatment for previously unvaccinated people who may be exposed to rabies is called post-exposure prophylaxis (PEP) for rabies, which involves thorough wound cleaning and passive neutralization of the virus by human invasion. It is included. Rabies immunoglobulin (HRIG) A series of four doses of rabies vaccine in and around the wound site and over a two-week period.

And in this latest study, conducted by a team of international experts from the United States and Israel, KEDRAB (HRIG150) is safe and effective for children when administered rapidly and appropriately as part of the rabies PEP process. It was the first HRIG to be shown to be relevant.

“Despite the majority of pediatric cases, limited safety and efficacy data were previously available. Pediatric patients“Dr. James Linakis, senior author of the Warren Alpert Medical School at Brown University, said.

“Evidence from this KEDRABUS pediatric trial is when this product addresses the unmet needs of children who may have been exposed to mad dog disease and prevents this fatal condition in countless young patients across the United States. We make sure that we give our healthcare providers confidence, “says the lead author, Dr. Nicholas Hobertporter, a pediatric emergency physician at Arkansas Children’s Hospital and Arkansas Children’s Hospital.

The study examined a group of 30 study participants who were identified as suspected of being exposed to rabies for 84 days (including a 3-month follow-up). Each participant received a PEP. KEDRAB infiltrated into and around the detectable wound site and / or was administered intramuscularly with the first of a four-dose series of rabies vaccines. Although this study did not include a placebo control group, placebo treatment in exposed patients is ethically unacceptable due to the nearly 100% case fatality rate of rabies.

No participants showed active rabies infection at any time, and there were no deaths or serious adverse events.

70% of participants experienced some form of unrelated or related side effects, all of which were mild.

“This study not only confirmed the safety and efficacy of KEDRAB, but also confirmed that all patients who participated in the study were well tolerated by KEDRAB,” said Dr. Novinyo Serge Amega, MD, US Medical Director of Kedrion Biopharma. Stated. “This is HRIG’s first and only pediatric study available in the United States, which may give doctors and other people who treat children exposed to rabies a healthy sense of security.”

Human rabies is extremely rare in the United States. An average of about two people die each year. The low incidence of rabies in the United States may be due to the success of pet vaccination and animal management programs, public health monitoring and testing, and the availability of post-exposure prophylaxis (PEP) for rabies. ..

It is important to note that KEDRAB is not licensed outside the United States. Therefore, the author has nothing to do with its use in other countries. Availability, accessibility, and affordability of PEPs in developing countries continue to be a major factor in the global burden of rabies.