New vaccine needed for serious childhood pneumonia

New vaccine needed for serious childhood pneumonia

A UNSW Sydney-led medical research team has called for a new vaccine, improved strategies and enhanced monitoring to combat serious complications from childhood pneumonia.

The researchers examined the impact of the 13-valent pneumococcal conjugate vaccine (13vPCV) on childhood pneumonia and empyema—complicated pneumonia—after its introduction to the Australian National Immunisation Program about a decade ago.

The new study, published in Thorax recently, found that while 13vPCV resulted in a 21% decrease in childhood pneumonia hospitalisations, there was a contemporaneous 25% increase in admissions for empyema.

This incidence data for childhood empyema hospitalisations is similar to that reported in other countries.

Approximately 7,000 Australians under the age of 18 are hospitalized with pneumonia each year.

Senior author Professor Adam Jaffe, Head of the School of Women’s and Children’s Health at UNSW Medicine & Health, said the researchers’ findings suggested an emergence of non-vaccine serotypes—those which 13vPCV does not cover.

13vPCV was introduced to cover the 13 most common serotypes responsible for invasive pneumococcal infection, extending coverage to six additional serotypes including 1 and 3.

The previous vaccine (7vPCV) covered seven serotypes. A serotype is a distinct variation within a bacteria species.

Prof. Jaffe said: “Although we found a substantial reduction in serotype 1, serotype 3 is now the predominant organism which causes childhood empyema—in 76% of cases—so, efforts must be made to create a vaccine which is more effective against serotype 3.

“In fact, Australia recently changed the vaccination dosage schedule to try and improve the effectiveness of 13vPCV against serotype 3, but we need to continue monitoring patients using molecular techniques to see if this change has had an impact.

“Childhood bacterial pneumonia and empyema are potentially preventable diseases through vaccination. So, if Australia can develop an effective vaccine, we could prevent children from being hospitalized with pneumonia and empyema.”

Empyema is infected fluid around the lungs and about 1% of children hospitalized with pneumonia develop it.

Although children are highly unlikely to die from empyema, they can expect a long stay in hospital for treatment with antibiotics and surgery, or the insertion of a drain. If adults develop empyema, about a third are likely to die.

Continuing enhanced surveillance needed

The researchers conducted a similar study during the period of the superseded 7vPCV. Their new study—which took four years to complete—is part of a broader research project on 13vPCV.

“Our new study had two parts,” Prof. Jaffe said. “We analyzed national hospitalisations for childhood empyema and childhood pneumonia, then we conducted an enhanced surveillance study on children with empyema.”

The first part of the research used publicly available hospitalisations data—about 36,000 admissions—to assess whether the introduction of 13vPCV changed how many children were admitted to hospital with pneumonia and empyema.

The enhanced surveillance study involved the collection of blood and lung fluid samples from 401 children with empyema from February 2015 to September 2018.

The children were receiving treatment in 11 major children’s hospitals across Australia.

Most children were boys (208 or 52%) and the median age was four years old.

The researchers then conducted molecular testing on these samples and compared the results to their previous study undertaken during the period of 7vPCV.

The multidisciplinary team included Dr. Nusrat Homaira, of the Discipline of Paediatrics at UNSW Medicine & Health, and pediatric research nurse Roxanne Strachan of Sydney Children’s Hospital.

Prof. Jaffe said: “Our new research is the first of its kind in Australia—so, we now have the best data available for complicated childhood pneumonia to help guide future vaccination introductions and improve vaccine strategies.

“We are currently working on our larger study, of which this was a subset, to examine the effectiveness of 13vPCV on children with bacterial pneumonia. We will need to repeat the study in a few years’ time to help with monitoring.

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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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Early birth linked to greater risk of hospital visits during childhood

Being born early (before 37 weeks’ gestation) is associated with a higher risk of hospital admission throughout childhood than being born at full term (40 weeks’ gestation), finds a study published by The BMJ today.

Although the risk declined as the children grew up, particularly after age 2, an excess risk remained up to age 10, even for children born at 38 and 39 weeks’ gestation, representing many potentially vulnerable children, say the researchers.

Preterm birth is a major contributor to childhood ill health. Existing evidence suggests that the risk of illness associated with preterm birth declines as children grow up, but it remains unclear at what age this begins to happen and how these changes vary by week of gestational age at birth.

To explore this further, a team of UK researchers set out to examine the association between gestational age at birth and hospital admissions to age 10 years and how admission rates change throughout childhood.

Their findings are based on data from more than 1 million children born in NHS hospitals in England between 1 January 2005 and 31 December 2006. Children were monitored from birth until 31 March 2015 (an average of 9.2 years per child), during which time the researchers analysed numbers of hospital admissions.

Gestational age at birth was analysed in weeks, from less than 28 up to 42 weeks.

Over 1.3 million hospital admissions occurred during the study period, of which 831,729 (63%) were emergency admissions. Just over half (525,039) of children were admitted to hospital at least once during the study period.

After taking account of other potentially influential risk factors, such as mother’s age, marital status and level of social deprivation, and child’s sex, ethnicity and month of birth, the researchers found that hospital admissions during childhood were strongly associated with gestational age at birth.

The hospital admission rate during infancy in babies born at 40 weeks was 28 per 100 person years—this figure was about six times higher in babies born extremely prematurely (less than 28 weeks). By the time the children were aged 7-10 years, the hospital admission rate in children born at 40 weeks was 7 per 100 person years—this figure was about three times higher in those born at less than 28 weeks.

But even children born a few weeks early had higher admission rates. Being born at 37, 38, and 39 weeks’ gestation was associated with a difference in the rate of admission of 19, 9, and 3 admissions per 100 person years during infancy, respectively, compared with those born at 40 weeks.

The risk of hospital admission associated with gestational age decreased over time, particularly after age 2. However, an excess risk remained up to age 10, even for children born at 38 and 39 weeks’ gestation.

Although this excess risk at 38 and 39 weeks was relatively small, the large number of babies born globally at these gestational ages suggests that they are likely to have a large impact on hospital services, say the researchers.

Infections were the main cause of excess hospital admissions at all ages, but particularly during infancy. Respiratory and gastrointestinal conditions also accounted for a large proportion of admissions during the first two years of life.

This is an observational study, so can’t establish cause, and the researchers point to some limitations, such as being unable to take account of several factors that can impact child health like maternal smoking and breastfeeding.

However, they say this was a large study using routinely collected data over a 10 year period, and the findings remained relatively stable after further analyses, suggesting that the results withstand scrutiny.

As such, the researchers say their findings indicate that gestational age at birth “is a strong predictor of childhood illness, with those born extremely preterm being at the greatest risk of hospital admission throughout childhood.”

And the finding that infections were the main cause of excess hospital admissions at all ages prompt the researchers to call for targeted strategies to help prevent and better manage childhood infections.

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Types of flu people encounter in childhood may affect susceptibility to different flu strains later in life

A team of researchers from the University of Pennsylvania, the University of Pittsburgh, Centro Nacional de Diagnóstico y Referencia, Nicaragua, and the University of Michigan has found that the strains of influenza virus that infect people when they are young may influence their susceptibility to other influenza strains later in life. In their paper published in Proceedings of the National Academy of Sciences, the group describes their study of influenza strains in ferrets and human blood samples and what they found.

As the researchers note, most people are first infected with an influenza virus at age five, when they first go to school. Thereafter, most people are exposed to and are infected by several influenza viruses throughout their lifetimes. Prior research has shown that the antibody response by an individual person to a specific influenza virus can be boosted by infections by other strains. In this new effort, the researchers sought to find out if the strain of influenza that infects a person early in their life might affect their ability to fight off other strains later in life. To find out, they conducted tests with two well-known strains of influenza, lab ferrets and human blood.

The experiments involved infecting ferrets or blood samples with one strain of an influenza virus and then attempting to infect them again with another strain—and also attempting to infect blood samples from people who had already had one or the other types of infection earlier in their life.

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