PENTA 20 (Odyssey)

21

Feb, 2022

Borrowing information across patient subgroups in clinical trials, with application to a paediatric trial

 

Authors: R.M. Turner, A Turkova, C.L. Moore, A Bamford, M Archary, L.N. Barlow-Mosha, M.F. Cotton, T.R. Cressey, E Kaudha, A Lugemwa, H Lyall, H.A. Mujuru, V Mulenga, V Musiime, P Rojo, G Tudor-Williams, S.B. Welch, D.M. Gibb, D Ford, I.R. White & and the ODYSSEY Trial Team

Published in: BMC Medical Research Methodology

21

Feb, 2022

Dolutegravir dosing for children with HIV weighing less than 20 kg: pharmacokinetic and safety substudies nested in the open-label, multicentre, randomised, non-inferiority ODYSSEY trial

 

Authors: H Waalewijn, M.K Chan, P.D.J Bollen, H.A Mujuru, S Makumbi, A.R Kekitiinwa, E Kaudha, T Sarfati, G Musoro, A Nanduudu, A Lugemwa, P Amuge, C.L Moore, P Rojo, C Giaquinto, A Colbers, D.M Gibb, D Ford, A Turkova, D.M Burger

Published in: The Lancet

21

Feb, 2022

Antenatal Seroprevalence of Zika and Chikungunya Viruses, Kingston Metropolitan Area, Jamaica, 2017–2019

 

Authors: J.J. Anzinger, C.D. Mears, A.E. Ades, K Francis, Y Phillips, Y.E. Leys, M.J. Spyer, D Brown, A.M.B.d Filippis, E Nastouli, T Byrne, H Bailey, P Palmer, L Bryan, K Webster-Kerr, C Giaquinto, C Thorne, C.D.C. Christie, and on behalf of the ZIKAction Consortium

Published in: Emerging Infectious Diseases Journal

 

16

Feb, 2022

VERDI General Assembly Meeting

 

On 26-28 January the VERDI General Assembly Meeting took place – an exciting 3-day online event bringing together experts in infectious diseases from the EU and beyond. The aim was to share our workplan, identify research areas of interest for the Consortium and prioritize crucial scientific questions about the epidemiology, transmission, disease progression and treatment of variants of SARS-CoV-2 among children and pregnant women, which the Consortium will collaboratively seek to answer.

There are several issues concerning the evolution of the pandemic that have emerged over the last months, many of which still require a coordinated effort in order to protect the health of women and children worldwide. For instance: What is the role of children in fuelling transmission of variants and future waves of infection? What are the short- and longer-term clinical consequences of infection with variants in children and pregnant women? And to what extent do newly emerging variants overcome existing natural and vaccine induced immunity in children and pregnant women, and do they impact on pregnancy outcomes?

VERDI is bringing together a diverse range of cohort studies: together we will collect and analyze data on variants of concern (VoC) from a wide and comprehensive variety of sources, and build on multi-disciplinary expertise from different institutions. By sharing information across existing cohorts, coordinating our efforts with other research consortia, sustaining plans for operational readiness of the cohorts, and recommending effective control and preventive measures for the spread of the virus, we wish to make the most out of this collaboration, seizing an incredible opportunity to learn from each other and make progress together.

15

Feb, 2022

Ecraid begins its fight against infectious diseases 

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New foundation: The European Clinical Research Alliance for Infectious Diseases has begun

 

Utrecht, Tuesday 15 February 2022 – In January 2022, Ecraid became a legal entity and is now fully operational to advance knowledge in the field of infectious diseases. This is Ecraid’s initial step as it evolves into a self-sustaining, not-for-profit organisation conducting clinical research for both public and private sponsors.

The expertise required to clinically evaluate new diagnostics, treatments, vaccines and other preventive and/or therapeutic interventions is not confined to a single institute or country. In fact, a lack of international collaboration and solidarity leads to fragmentation and isolation of research efforts, inefficient use of scarce research resources and suboptimal impact on the combat of infectious diseases. Ecraid will remedy this issue.

Thanks to funding by the European Commission and the Innovative Medicines Initiative (IMI) in recent years, the Ecraid network is able to conduct clinical research in reduced time, for reduced cost and of high quality. Ecraid’s clinical research network encompasses more than 2,000 sites in 40+ European countries. It includes primary care settings (general practitioners), hospital settings (emergency rooms and intensive care units), paediatric care settings, clinical laboratories, and long-term care facilities.

“This is an historical opportunity to amplify the public and private resources already invested in Europe to build sustainable clinical trial networks. Ecraid will enhance the effectiveness of clinical trials, in order to scientifically demonstrate the optimal care for patients with infections, either caused by emerging pathogens, such as SARS-CoV-2, or microorganisms no longer susceptible to current treatment, such as antibiotic-resistant bacteria” Marc Bonten, CEO of Ecraid and Professor of molecular epidemiology of infectious diseases at University Medical Center, Utrecht (the Netherlands).

The network will provide an efficient European infrastructure capable of performing all aspects of clinical studies from design to dissemination. It will function as the backbone of clinical research activity in the field of infectious diseases led by world-leading experts. Key design principles built into the network’s organisation and operations will ensure the delivery of rapid and coordinated research responses to public health emergencies that represent an imminent or immediate threat to the health and security of people living in Europe.

Led By Prof. Carlo Giaquinto, Penta will be representing the paediatric network in Ecraid. As such, Penta will coordinate studies in children and provide expertise in respiratory infections and neonatal sepsis. “Despite infections being one of the major causes of morbidity and mortality globally, still few anti-infective drugs are studied in the paediatric population. ECRAID will contribute to studying drugs in children in a multidisciplinary partnership”. 

 

Note for the editors

Ecraid is the envisaged, long-term successor of the European-funded projects COMBACTE and PREPARE. Over the next five years, ECRAID-Base will continue to develop Ecraid into a sustainable not-for-profit clinical research network.

COMBACTE (Combatting Bacterial Resistance in Europe) is part of the IMI-funded programme ND4BB (New Drugs for Bad Bugs) and focuses on improving the clinical development of antibiotics.

COMBACTE-NET, COMBACTE-CARE, and COMBACTE-MAGNET receive support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115523 | 115620 | 115737 resources of which are composed of financial contribution from the European Union Seventh Framework Programme (FP7/2007-2013) and EFPIA companies in kind contribution. COMBACTE-CDI receives support from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement n° 777362 resources of which are composed of financial contribution from the European Union’s Horizon 2020 research and innovation programme, and EFPIA.

PREPARE (the Platform for European Preparedness Against (Re-)emerging Epidemics) is a large scale European network, including 27 beneficiaries and is funded by the EU FP7 Programme. PREPARE started its activities in February 2014. PREPARE was funded by the European Commission’s 7th framework programme under grant agreement No 602525.

ECRAID-Base has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 965313.

Ecraid brand video: follow this link.

 

Contact for queries:Marc Bonten, CEO of Ecraid: M.J.M.Bonten@umcutrecht.nl

15

Feb, 2022

European RBDCOV project to study HIPRA’s COVID-19 vaccine in children adolescents and immunocompromised patients

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Funded by the Horizon Europe programme, RBDCOV will test the efficacy, tolerability, and safety of the vaccine against the different variants of COVID-19 using a recombinant protein.                

 

RBD Dimer recombinant protein vaccine against SARSCoV2” (RBDCOV) is a new Horizon Europe project led by the biotech pharmaceutical company HIPRA. Launched on 1st December, RBDCOV project objective is to test the efficacy, tolerability, and safety of the HIPRA’s recombinant Covid-19 vaccine in children (including adolescents) and immunocompromised people. The trials will last 2.5 years.

To carry out this project, HIPRA will work with an international consortium including companies and institutions from five European countries: Spain (IRSICAIXA, FUNDACIO HOSPITAL UNIVERSITARI VALL D’HEBRON, FUNDACION FILS DE LUCHA CONTRA ELSIDA (FLS), IDIBAPS, IDIBGI, ASPHALION, VINCES CONSULTING, ZABALA INNOVATION), United Kingdom (VERISTAT INTERNATIONAL), Italy (FONDAZIONE PENTA), Germany  (EUROPEAN AIDS TREATMENT GROUP), and Turkey (METPHARM ARASTIRMA GELISTIRME SAGLIK DANISMANLIK). The project will manage a budget of EUR 9.779.211,25 euros.

 

Prolonging the protection of immunocompromised persons

The RBDCOV project foresees two clinical trials, one in a group of immunocompromised individuals and the second study in one or more groups of children and adolescents. The RBDCOV project will contribute to the development of the HIPRA vaccine which aims to protect against severe COVID infection including in immunocompromised individuals and to ensure a long-term immune response.

The Project also envisages that the vaccine will be made accessible for vaccination campaigns worldwide thanks to its 2-8º C storage temperature, which facilitates a longer lasting shelf-life, transport, and distribution.

 

HIPRA’s vaccine

The COVID-19 vaccine being developed by HIPRA is a recombinant adjuvanted protein vaccine based on a Receptor Binding Domain (RBD) fusion heterodimer containing the B.1.1.7 (alpha) and B.1.351 (beta) variants of SARS-CoV-2.

  

RBDCOV and the impulse for innovation against COVID-19 in Europe

The Horizon Europe Framework Programme is Europe’s largest research and innovation programme (2021-2027), and one of its priorities is to support urgent research on coronavirus and its variants. The European Commission has selected eleven projects involving 312 research teams from 40 countries. RBDCOV is one of the selected projects that will support clinical trials for a new vaccine that can reach beyond Europe’s borders by creating links with other European initiatives.

Mariya Gabriel, European Commissioner for Innovation and Research, announced last year the approval of the RBDCOV project along with other 10 initiatives, stressing that investment in innovation is key to tackling the coronavirus crisis and strengthening current research infrastructures for the pandemic and future emergencies.

 

More information:

Press Officer:

Susana Garayoa sgarayoa@zabala.eu

Phone number: M (+32) 484 61 91 64

(Brussels)

 

Amaia Cabezón acabezon@zabala.es

Phone number: M (+34) 673 744 542

(Pamplona)

15

Feb, 2022

The European RBDCOV project will study HIPRA’s COVID-19 vaccine in children, adolescents and immunocompromised patients

Tags: ,

Funded by the Horizon Europe programme, RBDCOV will test the efficacy, tolerability, and safety of the vaccine against the different variants of COVID-19 using a recombinant protein.                

 

RBD Dimer recombinant protein vaccine against SARSCoV2” (RBDCOV) is a new Horizon Europe project led by the biotech pharmaceutical company HIPRA. Launched on 1st December, RBDCOV project objective is to test the efficacy, tolerability, and safety of the HIPRA’s recombinant Covid-19 vaccine in children (including adolescents) and immunocompromised people. The trials will last 2.5 years.

To carry out this project, HIPRA will work with an international consortium including companies and institutions from five European countries: Spain (IRSICAIXA, FUNDACIO HOSPITAL UNIVERSITARI VALL D’HEBRON, FUNDACION FILS DE LUCHA CONTRA ELSIDA (FLS), IDIBAPS, IDIBGI, ASPHALION, VINCES CONSULTING, ZABALA INNOVATION), United Kingdom (VERISTAT INTERNATIONAL), Italy (FONDAZIONE PENTA), Germany  (EUROPEAN AIDS TREATMENT GROUP), and Turkey (METPHARM ARASTIRMA GELISTIRME SAGLIK DANISMANLIK). The project will manage a budget of EUR 9.779.211,25 euros.

 

Prolonging the protection of immunocompromised persons

The RBDCOV project foresees two clinical trials, one in a group of immunocompromised individuals and the second study in one or more groups of children and adolescents. The RBDCOV project will contribute to the development of the HIPRA vaccine which aims to protect against severe COVID infection including in immunocompromised individuals and to ensure a long-term immune response.

The Project also envisages that the vaccine will be made accessible for vaccination campaigns worldwide thanks to its 2-8º C storage temperature, which facilitates a longer lasting shelf-life, transport, and distribution.

 

HIPRA’s vaccine

The COVID-19 vaccine being developed by HIPRA is a recombinant adjuvanted protein vaccine based on a Receptor Binding Domain (RBD) fusion heterodimer containing the B.1.1.7 (alpha) and B.1.351 (beta) variants of SARS-CoV-2.

  

RBDCOV and the impulse for innovation against COVID-19 in Europe

The Horizon Europe Framework Programme is Europe’s largest research and innovation programme (2021-2027), and one of its priorities is to support urgent research on coronavirus and its variants. The European Commission has selected eleven projects involving 312 research teams from 40 countries. RBDCOV is one of the selected projects that will support clinical trials for a new vaccine that can reach beyond Europe’s borders by creating links with other European initiatives.

Mariya Gabriel, European Commissioner for Innovation and Research, announced last year the approval of the RBDCOV project along with other 10 initiatives, stressing that investment in innovation is key to tackling the coronavirus crisis and strengthening current research infrastructures for the pandemic and future emergencies.

 

More information:

Press Officer:

Susana Garayoa sgarayoa@zabala.eu

Phone number: M (+32) 484 61 91 64

(Brussels)

 

Amaia Cabezón acabezon@zabala.es

Phone number: M (+34) 673 744 542

(Pamplona)

11

Feb, 2022

Closer to micro-elimination of HCV in Russian adolescents and children

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The REACH Consortium has just published the results of a multi-centre survey, aimed at assessing the uptake of Direct-acting antivirals (DAAs) for the treatment of HCV in children and adolescents living in Russia. The article is available as Open access in the Journal of Virus Eradication.

DAAs, new drugs used to treat chronic HCV, have demonstrated high rates of cure with minimal toxicity when compared to interferon-based regimens. They have been available for adults in Russia since 2015 and in 2019 they were approved for treatment of HCV in adolescents aged 12 and older. Several regimens are now approved for use in paediatric patients as young as 3 years of age. But there are knowledge gaps about the uptake of DAAs and no age-specific measures available that explore DAA uptake among adolescents and children.

The REACH survey is the first study focusing on the uptake of DAA treatment for Russian children and adolescents with HCV. It was conducted in 268 clinics in 85 administrative regions of the Russian Federation in September 2020. The REACH researchers have been able to identify and document contemporary policies and practices across Russia on clinical and therapeutic management of children with HCV, including pre-treatment monitoring strategies. Since DAAs were registered in Russia for treating adolescents in 2019 and recommended in the subsequent national paediatric HCV treatment guidelines, only 15% of adolescents in follow-up have received treatment.

Although the rollout of DAA in Russia is in the early stages, the uptake baseline established by the REACH Consortium is an essential step for the development of treatment guidelines and can inform the optimised use of DAAs, thereby improving the quality of life for patients and leading, in the long term, to the reduction of the burden of HCV.

The Russian Federation has the largest paediatric HCV disease burden in Europe with an estimated 118,000 children living with the disease. It is expected that by 2030, the prevalence of HCV in Russia could rise, emphasizing the importance of accelerating access to safe and effective treatments. Scaling-up of testing and treatment with the new drugs is a key strategic intervention set by WHO to achieve the treatment coverage targets for the elimination of viral hepatitis as a public health threat by 2030. The inclusion of children and adolescents in strategies to achieve this goal is essential especially because the development of paediatric drugs lags behind the development of adult formulations.

Read the full article here

11

Feb, 2022

Registration now open! PentaTr@ining 2022: HIV & other Congenital Infections

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We are delighted to announce that registrations are now open for our interactive training course ‘PentaTr@ining 2022: HIV & other Congenital Infections‘.

Building on the remarkable success of the previous online course in 2020/21, we have adapted our training content to deliver a cutting-edge training programme centered around updates in the management of paediatric HIV and a variety of different congenital infections. We have listened to participant feedback and carefully tailored the course to address the key issues that currently face paediatric infectious disease healthcare professionals and students.

The course is divided into two parts: in-depth online distance learning run over 3 months, later followed by a 3-day face-to-face workshop. The upgraded online course boasts a highly engaging design and user friendly interface, purposely designed to kindle engagement and encourage intercommunication among the participants and faculty team. The innovative online programme comprises 6 comprehensive and thought-provoking training modules, a variety of real life clinical cases for discussion, live webinars and dedicated tutoring from our expert trainers.

 

Modules covered:

  1. Preventing Vertical Transmission of HIV
  2. Congenital ‘SCORTCH’ Infections
  3. Children presenting with HIV
  4. Treating HIV in Children
  5. Complexities of HIV, Co-infections and Co-morbidities
  6. Adolescents, Sexual Health and ‘Living with HIV’

 

To complement the online training, our experienced international faculty will deliver a 3-day face-to-face training workshop on 28th-30th September 2022. The residential course embraces a true collegiate spirit, consisting of lectures, interactive working groups, real-life clinical case discussions and quizzes. The workshop is purposefully structured in a way that maximizes teacher/student interaction, encourages delegates to be proactive participants and consolidates the knowledge they will have acquired during the online component.

The course will be held at the historic venue of Pontificia Università Urbaniana, Rome (Italy).

The online course kicks off on 25th April 2022

==========>>    Sign up today for our special ‘Early Bird’ rate    <<==========

 

10

Feb, 2022

Save the date! Penta aperitivo webinar 17 Feb 2022

 

The Penta Aperitivo webinars are here to keep you up to date with the latest Penta activities and on the new developments on the prevention, diagnosis, and treatment of infectious diseases in children.

The next webinar with top experts from our Network will focus on pediatric ARV trials and on the treatment of congenital CMV.

 

Date: Thursday, 17 February 2022

Time: 19:00 – 20:00 CET (Italy time) // 18:00-19:00 (UK time)

Chairs:

Di Gibb, MRC Clinical Trials Unit at UCL, UK

Pauline Amuge, Baylor College of Medicine Children’s Foundation, Uganda

 

Agenda:

  • What is new in Penta pediatric ARV trials? (20 minutes)

Pablo Rojo Conejo, Universidad Complutense de Madrid, Spain

 

  • What could be the next trials on cCMV? (20 minutes)

Hermione Lyall, Imperial College Healthcare NHS Trust, UK 

Daniel Blazquez Gamero, Hospital Universitario 12 de Octubre de la Comunidad de Madrid, Spain

 

  • Q&A time (20 minutes)

 

If you have not received the invite and are interested to join the webinar, contact us at network@pentafoundation.org

NEWSLETTER

We would like to update you on our recent activities