Study Supports Rabies Immunoglobulin for Post-Exposure Prophylaxis in Kids

NEW YORK (Reuters Health) – In children with confirmed or suspected rabies, human rabies immunoglobulin (HRIG) appears to be an effective part of the post-exposure prophylactic (PEP) treatment, researchers say.

“We know the incidence of kids being exposed to animals that may transmit rabies is high,” Dr. Novinyo Amega of Kedrion Biopharma, in Fort Lee, New Jersey, told Reuters Health by email. “However, little data exist that can help clinicians better understand the safety profiles of the various HRIG products currently available.”

Dr. Amega and colleagues conducted a phase-4 prospective, single-arm clinical trial of KEDRAB, an HRIG distributed by Kedrion Biopharma and approved by the U.S. Food and Drug Administration (FDA) in 2017, in 30 patients under 17.

All participants had confirmed or suspected rabies exposure in which PEP was indicated. This included standard-of-care wound washing, passive immunization with HRIG, and induction of active immunity through initiation of the rabies vaccine series. No placebo group was used, as this would have been ethically unacceptable due to the high fatality rate of rabies, the researchers say.

Participants received 20 IU/kg of HRIG150 (150 IU/mL) infiltrated into the wound site or sites. Any remainder was injected intramuscularly, concomitantly with the first of a four-dose series of rabies vaccine. Rabies virus neutralizing antibody (RVNA) titers and tolerability were assessed on day 14 following administration of the last vaccine dose.

There were no serious adverse events, rabies infections, or deaths, the researchers report in Human Vaccines and Immunotherapeutics. Twelve participants experienced a total of 13 adverse events deemed related to the study treatment, but all were mild.

By day 14, RVNA levels had reached at least 0.5 IU/mL in all but two of the participants. However, say the investigators, testing was “not repeated subsequently; thus, it remains possible that the two subjects that did not attain the cutoff by day 14 seroconverted by day 30.”

The study results have been submitted to the FDA for review, Dr. Amega said, adding, “we are pleased to see that top-line results of this pediatric study support KEDRAB’s safety profile. Importantly, we believe that meeting the primary objective of this study could further differentiate KEDRAB from other currently available HRIGs in the U.S.”

Kamada Ltd, which manufactures KEDRAB, and Kedrion Biopharma funded the study. Most of the authors are employees of these companies.

SOURCE: https://bit.ly/3u3cvhH Human Vaccines and Immunotherapeutics, online February 9, 2021.

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Oxford Launches COVID-19 Vaccine Study in Children

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

Oxford University is starting a COVID-19 vaccine study with children and young adults between ages 6 and 17.

At Oxford and three partner sites in London, Southampton, and Bristol, the phase 2 clinical trial will test whether kids and teens have a good immune response to the AstraZeneca vaccine. Previous trials have shown that the shot is safe in children.

“While most children are relatively unaffected by coronavirus and are unlikely to become unwell with the infection, it is important to establish the safety and immune response to the vaccine in children and young people as some children may benefit from vaccination,” Andrew Pollard, PhD, the chief investigator for the trial and a professor of pediatric infection and immunity at Oxford, said in a statement.

The new trial will enroll 300 volunteers, with up to 240 receiving the vaccine. The control group will receive a meningitis vaccine, which is safe in children and produces similar side effects to the COVID-19 vaccine, such as a sore arm.

COVID-19 vaccine trials have included children over age 12, so this marks the youngest group to be tested so far. Pfizer, Moderna, and Janssen have announced plans to start trials in younger children this spring, according to The Washington Post. Widespread vaccination in children likely won’t occur until 2022, the newspaper reported.

The trial launched on Friday, and the first vaccinations are expected by the end of the month. Parents can visit Oxford’s COVID-19 Vaccine Trial website to sign their children up for the study.

“This study will play an important role in helping to protect children in the future,” Grace Li, a pediatric clinical research fellow for the Oxford Vaccine Group, said in the statement.

“We’ve already seen that the vaccine is safe and effective in adults, and our understanding of how children are affected by the coronavirus continues to evolve,” she said.

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