News

7

Dec, 2021

REACH project published in CORDIS

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We are proud to announce that the REACH project’s Result in Brief article, Reducing infectious disease in mothers and children in Russia, has been uploaded on the CORDIS website. This is a great opportunity to share our work, with the rest of the world and will ensure that our study results, when available, are available to many. None of what REACH has achieved would have been possible without the collaborative effort of our partners in Europe and the Russian Federation.

Through the joint commitment of our members, the REACH project has drawn to conclusion, having strengthened, and created new international relationships to elevate research opportunities. We must keep this momentum and not waiver in our drive to improve health responses to pandemics and advance our understanding of HIV, TB, and HCV in order to protect pregnant women and children, the vulnerable populations that are usually considered last for clinical trials.

Visit the CORDIS website to read the Results in Brief article

 

 

 

1

Dec, 2021

World AIDS Day 2021: How paediatric HIV has changed in the last 30 years

 

It takes a community of people working together to achieve the results we are looking for: eradication HIV in children

 

The paediatric HIV pandemic has changed from when researchers first began investigating HIV in children to where we stand today.

The burden of perinatal infections, however, remains high. Perinatal infections occur when a pregnant person living with HIV passes HIV to her baby either during pregnancy, delivery or through breastfeeding. Despite unprecedented advances in the prevention of perinatal infections (including those occurring through breastfeeding) utilizing maternal ART and infant post- exposure preventative treatment, new infections continue. An estimated 1.8 million children under 15 years of age are living with HIV-1 globally, and 5 million survive to become adolescents and young adults with perinatal infection. In addition, around 150,000 children are born with HIV-1 annually, with about half of new infections occurring before and during birth and half through breastfeeding. The COVID-19 pandemic, through disruption of clinical care and its economic impact, increased these numbers in 2021 and beyond.

A multidisciplinary, multicultural approach to combat pediatric HIV-1 infection and discover immunotherapeutic strategies towards HIV remission, has been catalyzed by the EPIICAL consortium. The EPIICAL group of investigators and clinicians, through a number of virological and immunological studies conducted both in European HIV infected cohorts as well as in HIV positive African children, has gathered further evidence of efficacy of early therapy to reduce the amount of the virus within individuals and boost of specific immune responses. These studies will pave the way for further therapeutic strategies towards HIV remission using immunotherapeutic approaches.

From the clinical perspective, adherence in mother and child are strongly associated with achieving any therapeutic success. Barriers to the mother taking her therapy often mean that the child will also not be protected! But the mothers, if given the opportunity, do an amazing job at administering therapy to their children. It takes a community of people working together to achieve the results we are looking for and the work of social scientists plays a crucial role in identifying interventions that address non-adherence in mothers and children.

Holly Peay, senior Research Scientist at RTI International and EARTH social and behavioural study lead in EPIICAL, states that “Young children with HIV cannot control their own adherence. It is important to understand attitudes and barriers to adherence experienced by caregivers of children with HIV. That allows us to choose interventions that are targeted to the problems that caregivers experience and gives us hope that improving adherence in children will also improve adherence in their mothers and other HIV positive caregivers.”

The bottom line is, testing should never be delayed and early intervention can save the lives of both mother and the young child because when the mother is suppressed, the child is also likely to be suppressed.

Visit the EPIICAL website to learn more about the project.

Neonatal Intensive Care Unit in Padova University Hospital, Italy

27

Nov, 2021

NeoVanc: New study finds no clear benefit from a shorter optimised vancomycin treatment in babies with Gram positive late onset sepsis

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NeoVanc, a European trial featured in The Lancet Child & Adolescent Health, has published the findings of the largest neonatal vancomycin efficacy trial ever conducted. NeoVanc was a European, multicentre research study coordinated by Penta and funded by the European Commission’s 7th Framework Programme. It compared the efficacy, safety and pharmacokinetics of an optimised dosing regimen with a standard dosing regimen of vancomycin in infants with late onset sepsis. The NeoVanc programme* took place between March 2017 and July 2019 and involved 242 infants with serious infections from 22 neonatal intensive care units in Italy, Greece, Estonia, Spain and the UK. The aim of the study was to compare recovery from sepsis as well as relapses or new infections requiring further treatment between the two groups.

Dr Louise Hill, Lecturer in Paediatric Infectious Diseases at St George’s, University of London said, “Neonatal sepsis is a global health priority with around 3 million cases per year worldwide.  Premature babies and infants in the first 3 months of life represent a particularly vulnerable group because their immune systems are not yet fully developed. In Europe, coagulase-negative staphylococci (CoNS) are the most frequently identified bacteria in neonatal late onset sepsis and vancomycin is the antibiotic most commonly used to treat them.  However, despite being used for over 50 years, there are very few studies comparing different dosing regimens of vancomycin.”

To bridge this gap, the NeoVanc set out to compare the efficacy of administering an optimised regimen with a first (loading) dose of 25 mg/kg of vancomycin followed by lower doses of 15 mg/kg (at intervals determined by postmenstrual age (PMA)) over a shorter 5-day course with a standard 10-day course with lower daily dosing of 15 mg/kg of the drug throughout.

According to the Chief Investigator, Professor Mike Sharland of the Paediatric Infectious Diseases Research Group at St George’s, University of London, “the results of the study show that there is no clear advantage for adopting a shorter 5-day course, with a loading dose, over the standard 10-day course in infants under 3 months of age with severe sepsis.”

What emerged from the study was that babies in the shorter 5-day course group were more commonly assessed as not fully recovered by the end of treatment as compared with babies in the longer course group. Furthermore, twice as many babies (30%) in the short course group failed routine hearing testing compared to the longer course (15%), making further research in this area a priority.

In light of this finding, Professor Sharland added: “A NeoVanc follow-up study is currently underway to collect long-term hearing data on those infants who were affected by hearing dysfunction, particularly in relation to the use of the shorter treatment course.”

Read the paper on The Lancet Child Adolescent Health

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About the article

The article is: Optimised versus standard dosing of vancomycin in infants with Gram-positive sepsis (NeoVanc): a multicentre, randomised, open-label, phase 2b, non-inferiority trial

Louise F Hill*, Michelle N Clements*, Mark A Turner, Daniele Donà, Irja Lutsar, Evelyne Jacqz-Aigrain, Paul T Heath, Emmanuel Roilides, Louise Rawcliffe, Clara Alonso-Diaz, Eugenio Baraldi, Andrea Dotta, Mari-Liis Ilmoja, Ajit Mahaveer, Tuuli Metsvaht, George Mitsiakos, Vassiliki Papaevangelou, Kosmas Sarafidis, A Sarah Walker, Michael Sharland, on behalf of the NeoVanc Consortium†

The Lancet Child & Adolescent Health 2021, published online Nov 26 https://doi.org/10.1016/S2352-4642(21)00305-9

Lancet (thelancet.com)


*About NeoVanc
The NeoVanc project set out to analyse the adaptability of an off-label medicine, vancomycin, to the specific needs of neonates and infants, by developing an optimal dosing regimen. Coordinated by Penta and funded by the European Commission’s 7th Framework Programme, NeoVanc has successfully recruited almost 250 participants, and involved more than 20 sites in 5 European countries. This randomised, open label, phase IIb study compares the efficacy, safety and pharmacokinetics of an optimised dosing regimen with a standard dosing regimen of vancomycin in neonates and infants with late onset bacterial sepsis. The study team is currently developing publications to present the results to the wider public.

25

Nov, 2021

Public consultation on the draft WHO Essential Medicines List Antibiotic Book

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WHO has launched a public call for comments on the draft of WHO Essential Medicines List Antibiotic Book.

The book provides guidance on the prescribing and use of the antibiotics on the WHO Model List of Essential Medicines for over 30 common infections in both the community and hospital setting for children and adults. The draft publication has been developed by an international expert working group of specialists in infectious diseases, antimicrobial resistance and public health. It reflects the recommendations for antibiotics made by the WHO Expert Committee on Selection and Use of Essential Medicines, including the AWaRe (Access-Watch-Reserve) classification of antibiotics.

The draft publication is accompanied by a series of infographics for individual infectious syndromes and Reserve group antibiotics, intended to be a quick-reference, user-friendly and portable resource for clinicians to carry with them while seeing patients.

We encourage individuals and groups to engage with this public consultation, that aims to ensure that the content is accurate, relevant and addresses the needs of the intended audience.

The consultation is open to healthcare providers, government officials, civil society organizations, international organizations, research institutions, and interested citizens and stakeholders from all over the world. Inputs collected during the public consultation will be considered in the revision and finalization of the publication and infographics.

All comments related to the draft WHO Essential Medicines List Antibiotic Book shall be submitted through the online platform (preferred), or via email to aware@who.int

The public consultation ends on 31 January 2022, 23:59, CET.

19

Nov, 2021

In Memory of Dr Scott M. Hammer

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With a great sadness I learnt today that Scott passed away. The IAS obituary says everything about him as a great scientist. I just would like to remember him as a very good friend who cared about children throughout his professional life. In 2006 we chaired together the WHO working group to develop the guidelines for antiretroviral  therapy “Toward universal access”. Scott has been mentoring me in an unforgettable way !

Carlo Giaquinto on behalf of Penta

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The IAS-USA is deeply saddened by the passing of Dr Scott M. Hammer on November 17, 2021. Dr Hammer has been a hero in the HIV pandemic during his 5-plus decades of work in the field of infectious diseases.

For the IAS-USA, Dr Hammer served as a pivotal contributor to all of our educational activities, including the first Antiretroviral Therapy Guidelines panel established in 1996, published in the Journal of American Medical Association every other year. Dr Hammer served as Chair of the ARV Guidelines in 2006 and 2008.

Most importantly, we remember Dr Hammer as a brilliant scientist, compassionate physician, extraordinary, generous, and caring friend, and one of the most humble individuals that anyone in our field has had the honor to work with.

Dr Hammer was presented with the IAS-USA Lifetime of Leadership Award in 2019. Although it is with a profound sense of loss at his passing, Dr Hammer’s example inspires us to redouble our efforts to advance the IAS-USA mission. He will be missed, but the legacy of all of his contributions and kindness will endure in the hearts and minds of all of us.

IN MEMORIAM: Dr Scott M. Hammer – IAS-USA (iasusa.org)

15

Nov, 2021

VERDI project launches

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Today we launch VERDI, a project that prioritizes women and children in the research on new coronavirus variants

The University of Padua and Penta Foundation are leaders of VERDI, a new European research consortium on coronavirus in children and pregnant women. Carlo Giaquinto, Professor at University of Padova and President of Penta, together with Professor Ali Judd at University College London, will be the scientific coordinators of VERDI.

 

Padova, Italy – 15 November 2021

Children and pregnant women have taken a back seat during the COVID-19 pandemic. With children most likely to be the last to be vaccinated and pregnant women often advised against the vaccine, they risk becoming a population at high risk of developing new variants of the SARS-CoV-2 virus.

In fact, children have generally been developing the disease in a mild and asymptomatic form, and pregnant women rarely transmit the virus to the fetus. With the emergence of coronavirus variants, however, the potential impact of the infection on this population and its role in the transmission of the virus (e.g. in the family, at school and/or other life contexts) is unknown.

“The research on COVID-19 in children started very late, due to the false belief that children were not affected and not important for understanding the dynamics of the pandemic”, stated Carlo Giaquinto, Professor at the University of Padua and President of the Penta Foundation. “It is extremely important that we eventually recognize the key role that children and adolescents play in the epidemic and the natural history of childhood infection, with particular reference to the long-term consequences of the infection.”

VERDI (SARS-CoV-2 variants Evaluation in pRegnancy and paeDIatrics cohorts), funded by the European Commission with a contribution of 10 million euros, devotes an international and collaborative effort to analyse the impact of new variants in these vulnerable populations.

The research group, made up of 22 centers of excellence in Europe, USA, South Africa, the Caribbean, the Middle East and Asia, coordinated by the University of Padua and Penta Foundation (Italy), will study the mechanisms of development and diffusion of coronavirus variants as well as their impact on health. It will thus provide useful information for the control of this infection in the various geographical contexts and the improvement of vaccination strategies.

The consortium will share data on coronavirus variants from patient medical records, cohort studies, home transmission studies and screening programs, which will be analyzed in a harmonized manner across the research centers. The monitoring of this population remains a fundamental action to tackle the coronavirus and control the spread of variants, especially in a rapidly evolving epidemiological context due to the increase in vaccination activity as well as the variants.

“The University of Padua and its partners bring to the VERDI project an extraordinary ability to collect and analyse epidemiological data. VERDI Consortium will collaborate with other European research infrastructures (ORCHESTRA, RECOVER, RECODID and ECRAID) to ensure full circulation of research results and their immediate application to treatment and prevention strategies at global level” announced Prof. Carlo Giaquinto.

The results of this collaborative research will serve to find ourselves less unprepared for future health emergencies.

12

Nov, 2021

World Pneumonia Day 2021: Every breath counts

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It’s impossible to ignore the Covid-19 pandemic and how it has gripped the lives of everyone around the world, but it is equally impossible to ignore the thousands of lives that are lost daily to chest infections (pneumonia). According to UNICEF, pneumonia is the single largest cause of death in children under five and the majority of these deaths occur in low- and middle-income countries.

Pneumonia needn’t be the deadly infectious disease that it is today. Through immunization, nutritional interventions, and controlling environmental risk factors the burden of child pneumonia can be reduced.

Progress in reducing pneumonia deaths in children under five has been significantly slower than for other infectious diseases and more needs to be done.

Clinical trials play a crucial role in improving the evidence for the right drug, dose, duration and delivery of medicines for children. However, there are currently very few trials that are aimed at the optimal management of children admitted to hospital with severe pneumonia. For the well-being of these children, this needs to change and PediCAP is now recruiting across Africa to try and help answer these questions.

Visit the PediCAP website to find out more about our effort to support clinical decision-making for severe childhood pneumonia requiring inpatient care in lower and middle-income countries.

29

Oct, 2021

ODYSSEY trial wins 2021 Hector Award

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It was announced at the 8th European AIDS Conference that Angela Colbers and David Burger received the Hector Research Award in HIV 2021 in clinical and/or epidemiological science on behalf of the ODYSSEY trial team!

The winning paper Simplified dolutegravir dosing for children with HIV weighting 20kg or more pharmacokinetic and safety substudies of the multicentre randomised ODYSSEY trial, can be found here.

Congratulations to the entire study team and thank you to all the families and children who participated in the ODYSSEY trial.

Sponsored by Penta and funded by ViiV Healthcare, the ODYSSEY trial’s main objective was to evaluate the efficacy and safety of a once daily dose of dolutegravir-based antiretroviral therapy compared with the current standard HIV treatment in children and adolescents with HIV.

20

Sep, 2021

PentaTr@ining kicks off HIV and other Congenital Infections course, in Spanish

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The Spanish language version of our online course “PentaTr@ining: HIV and other Congenital Infections” kicks off today! We look forward to welcoming over 100 participants for this year’s edition of our newly upgraded online training course.

Unique in its design and delivery, ‘PentaTr@ining’ is an innovative training platform which continues to develop and evolve in response to the changing needs of children, young people and pregnant women living with HIV and other congenital infections. Our flagship online course is highly interactive and clinical case based, designed to kindle engagement and foster intercommunication among the students and faculty team. It consists of 6 fortnightly modules with associated pictures, infographs, tables and figures, references and links to major paediatric infectious disease websites of interest. The modules are designed in a way that consolidates knowledge acquired as the course progresses, always encouraging the delegates to be proactive participants.

Visit the Pentatr@ining website for more information about our training initiatives.

7

Sep, 2021

Project New Generation (PNG+)

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Project New Generation (PNG+) are a group of young people living with HIV who serve as the voice of the youth involved in the REACH study. Made up of two groups, one based in St. Petersburg and the other in Irkutsk, and supported by local psychologists, this group of 20 bring to the forefront, issues that the youth living with HIV are directly affected by. The activities of PNG+ are led by the Penta PPI team.

Pre-COVID-19, the PPI team held a number of in-person meetings with the young people, running training on Cohort Studies and understanding REACH, exploring the issues faced by young people living with HIV, Hepatitis C and TB and then looking at ways to share the findings from the study. Given the circumstances the world finds itself in today, the meetings moved to Zoom to continue the engagement, using similar techniques and approaches but tailoring the meetings to suit a digital format. Doing this has allowed the work to continue.

During the meetings, time was spent discussing how the key findings reflect what it’s like to be a young person living with HIV in Russia, and the group decided on the best ways to share the findings with young people living with HIV and their families across Russia. In between virtual meetings, the young people have been engaged via WhatsApp, sharing images and information to discuss and images and ideas for them to comment on. The PPI team have created an Instagram profile, @penta.youth which is being used to share the young people’s work and findings. The learning from this work it is now being rolled out across Penta’s other PPI work.

Young people having a voice and understanding of cohort studies and research is extremely important. The group reported that they enjoyed being a part of REACH and learning about studies. This group are keen to share their experiences and educate their peers and the general public. There is still much work to do to continue to build the relationship between them and medical professionals and develop robust youth engagement at all levels. Over the lifespan of REACH have seen the group grow and develop their soft skills such as confidence, teamwork, and communication. Our hope is to be able to continue engaging them with activities and opportunities in the future.

Here is to many more adventures with PNG+!

Find out more about PNG+ here

NEWSLETTER

We would like to update you on our recent activities