Infectious Disease

The examine demonstrates the protection and effectiveness of immunoglobulin from human rabies in kids

February 18, 2021

3 min read

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Hobart-Porter does not report any relevant financial information. In the study you will find all relevant financial information from all other authors.

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A phase 4 study showed that a human rabies immunoglobulin was safe and effective in children when given as part of post-exposure rabies prophylaxis, researchers reported in Human Vaccines & Immunotherapeutics.

Rabies is rare in the United States. According to the CDC, only 25 cases were reported from 2009 to 2018. During that time, only three cases occurred in children under the age of 18, including at least two caused by a bat bite, which has been the leading cause of rabies in the United States for the past 60 years

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Globally, however, the WHO estimates that 40% of rabies cases occur in children under the age of 15, with most encounters being caused by dog ​​bites. This emerges from a press release in which the results of the new study are published. Once clinical symptoms appear, rabies is almost always fatal.

Currently, the CDC and AAP treatment recommendations call for post-exposure prophylaxis (PEP) that combines human rabies immunoglobulin and a series of four doses of rabies vaccine on days 0, 3, 7 and 14.

In their study Nicholas Hobart-Porter, DO, an emergency physician at Arkansas Children’s Hospital, and colleagues enrolled 30 study participants aged 17 years or younger with confirmed rabies exposure who had received human rabies immunoglobulin (HRIG150; KEDRAB 150 IU / mL) as part of Rabies PEP.

Following the administration of KEDRAB, subjects were assessed by follow-up exams on days 3, 7 and 14, while follow-up exams were held on days 1, 28, 56 and 84.

After the administration of KEDRAB, the participants’ parents and guardians were given “diary cards” and the guardians were instructed to record information about any adverse events (AEs).

After the 84-day study, 28 patients completed the study. Two participants were lost to follow-up care. The mean age of the participants was 7.45 years and ranged from 0.5 to 14.9 years. The majority of the patient population was white (21; 70%), seven (23.3%) were black, and two (6.7%) were Asian.

Of all 30 participants who were suspected of being exposed to rabies, three (10%) were from animals confirmed to be rabies while the others were associated with confirmed negative animals. All participants were free of rabies on the 14th day of the experiment, and none of the participants developed an active rabies infection.

No participant reported severe AE. After 14 days of the study, 21 of the 30 participants (70%) had treatment-related AE, with a total of 57 reported, all of which were reported as mild. The most common AEs reported were pain at the injection site.

“We conclude that HRIG150 is useful as a life-saving component of PEP in pediatric patients,” the authors wrote.

According to the new version, it was the first study to show that HRIG in children was safe and effective when given promptly as part of the rabies PEP process.

“This KEDRAB US Pediatric Trial shows that this product addresses an unmet need in children who may have been exposed to rabies and enables healthcare providers to prevent the fatal condition of countless young patients in the United States,” said Hobart Porter said in a press release.

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Richard F. Jacobs, MD

Richard F. Jacobs

The study by Hobart-Porter and colleagues provides an assessment of the use of HRIG150 in children under the age of 17 who required rabies prophylaxis (PEP) for vulnerable animal bites. The selected patients met the criteria for the need to include PEP, HRIG150 and rabies vaccine according to established clinical guidelines.

The primary purpose of this phase 4, two-center, open-label, single-arm clinical trial was to determine the safety of HRIG150 administration according to established guidelines for the location and method of administration based on studies in adults. They also examined the immunogenicity of co-administration of a rabies vaccine given at the same time as HRIG150.

Although the authors state that they also demonstrated effectiveness, this was an open-label, one-arm study, and while there were no rabies deaths, this study was not a randomized controlled trial. This is understandable given the potential severity of the disease and the establishment of current guidelines for the use of HRIG and vaccines in potentially high-risk exposures to potentially rabid animals.

This study provides valuable information on the safety of HRIG150. There were no serious side effects and no adverse effects on immune responses to the vaccine. Both endpoints support adult data and provide extremely valuable support for the use of HRIG150 in children. The side effects observed were all mild and included injection site pain (five; 16.6%), injection site erythema (one; 3.3%), fatigue (two; 6.7%), and one each (3.3 %) of vomiting, pyrexia and body elevation and headache.

These are very common mild side effects with almost all injectable vaccines and immunoglobulins. Like so many drugs, vaccines, and biologics used in humans, there is ample evidence of safety and immunogenicity in adults.

The availability of data in children from such clinical studies is always necessary and valuable to ensure the safe use of these products. A wise pediatrician once said, “Children are not just little adults when it comes to drugs, vaccines, and other products.” This study should help the large numbers of doctors, patients, and families recommended to be given PEP for rabies exposure, give safety.

Richard F. Jacobs, MD

Editor-in-chief

Infectious diseases in children

Professor emeritus

Arkansas University of Medical Sciences

Disclosure: Jacobs does not report any relevant financial information.

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