Rabies treatment demonstrated as safe and effective for use in children in first pediatric trial

February 10, 2021

A treatment, known as KEDRAB (Rabies Immune Globulin [Human]), currently used in the prevention of rabies has been demonstrated to be safe and effective for patients age 17 and under.

Results published today in Human Vaccines & Immunotherapeutics report the first and only pediatric trial of any human rabies immunoglobulin (HRIG) currently available in the US. Findings have been submitted to the US Food and Drug Administration for review.

In the United States, someone is treated for possible exposure to rabies every 10 minutes. Globally, the World Health Organization (WHO) estimates that rabies causes 59,000 human deaths annually in over 150 countries, with 95% of cases occurring in Africa and Asia - however they concede it is likely a gross underestimate of the true burden of disease.

The WHO also estimates that 40% of the global rabies disease burden occurs in children under 15 years of age, and that most encounters of the disease follow a dog bite.

Once clinical symptoms appear; rabies is virtually 100% fatal.

The current treatment for previously unvaccinated people potentially exposed to rabies is called rabies post-exposure prophylaxis (PEP), which includes thorough wound washing, passive neutralization of the virus with infiltration of human rabies immune globulin (HRIG) into and around the wound site, and a series of 4 doses of rabies vaccine given over a 2-week timeframe.

And in this latest study carried out by a team of international experts from the US and Israel, KEDRAB® (HRIG150) has become the first HRIG shown to be safe and effective in children when administered promptly and properly as part of the rabies PEP process.

"Despite the large proportion of pediatric cases, limited safety and efficacy data had previously existed for use in pediatric patients," says senior author Dr James Linakis, from the Warren Alpert Medical School of Brown University.

"Evidence from this KEDRAB US Pediatric Trial confirms that this product addresses an unmet need in children who may have been exposed to rabies, and gives healthcare providers confidence when preventing this deadly condition in countless numbers of young patients across the US," says lead author Dr Nicholas Hobart-Porter, Pediatric Emergency Physician at University of Arkansas for Medical Sciences and Arkansas Children's Hospital.

The study looked at a group of 30 trial participants, with suspected or confirmed rabies exposure, over an 84-day period (as to include a 3-month follow-up). Each participant received PEP. KEDRAB was infiltrated into and around detectable wound site(s) and/or given intramuscularly along with the first of a 4-dose series of rabies vaccine. Although the study did not include a placebo control group, placebo treatment of exposed patients is ethically unacceptable due to the near 100% fatality rate of rabies.

No participant showed an active rabies infection at any point, and there were no deaths and no serious adverse events.

While 70% of participants experienced some form of unrelated or related side effect, all of these were mild.

"The study not only confirms the safety and efficacy of KEDRAB, but also that KEDRAB could be well tolerated by all patients who participated in this trial," says Novinyo Serge Amega, M.D., head of US Medical Affairs at Kedrion Biopharma. "It was the first and only pediatric study of any HRIG available in the United States and, as such, may provide a healthy degree of reassurance for physicians and others who treat children exposed to rabies."

In the US, rabies in humans is extremely rare; with around two deaths on average per year. The low incidence of human rabies in the US can be attributed to successful pet vaccination and animal control programs, public health surveillance and testing, and availability of post-exposure prophylaxis (PEP) for rabies.

It is important to note, that KEDRAB is not licensed outside the United States. Therefore, the authors cannot make any connection to its use in other nations. Availability, accessibility and affordability of PEP in developing nations remains a major component of the global burden of rabies.
-end-


Taylor & Francis Group

Related Rabies Articles from Brightsurf:

Grassroots dog vaccinations can help stop rabies, but not alone
While scientists are trying to find a vaccine for COVID-19, the rabies virus continues to kill 59,000 people every year.

Rabies: New prophylactic and therapeutic avenues
Rabies is still responsible for approximately 60,000 human deaths per year mostly in Asia and Africa and affects especially underserved people.

WSU's One Health approach is a two-for-one stop for health care in Tanzania
Promoting healthcare strategies that target both human and animal populations at the same time can save money, participant time and result in a two-for-one stop for health care services.

Scientists make vampire bats 'glow' to simulate vaccine spread
University of Michigan scientists and their colleagues used glowing fluorescent gel to test the potential effectiveness of vaccines to control rabies and other diseases in wild bats.

Researchers develop a faster, stronger rabies vaccine
Every year, more than 59,000 people around the world die of rabies and there remains no cheap and easy vaccine regimen to prevent the disease in humans.

Scientists crack rabies virus weaponry
Researchers from Monash University and the University of Melbourne have found a way to stop the rabies virus shutting down the body's immune defence against it.

Dog rabies vaccination programs affect human exposure, prophylaxis use
The World Health Organization has made it a goal to eliminate human rabies deaths due to dog bites by the year 2030.

Public health experts urge people to seek prompt medical advice if they suspect rabies exposure
There is only a short window of opportunity to seek medical help before rabies becomes almost invariably fatal, but people wait an average of 10 days before seeking medical advice following exposure to potentially rabid animals overseas, according to new research being presented at this year's European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Amsterdam, Netherlands (April 13-16).

Bid to beat rabies could benefit from oral dog vaccine, study finds
Vaccines hidden in dog food could help curb the spread of rabies in countries with large populations of stray dogs, research suggests.

Interventions in dog populations could reduce rabies in rural China
Domestic dogs play a key role in the transmission and expansion of rabies in rural areas of China, according to a study published Dec.

Read More: Rabies News and Rabies Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.