Results from the WHO external quality assessment for the respiratory syncytial virus pilot, 2016‐17

Jackson, Sandra; Peret, Teresa C. T.; Ziegler, Thedi; Thornburg, Natalie J.; Besselaar, Terry G.; Broor, Shobha; Barr, Ian G.; Baumeister, Elsa; Chadha, Mandeep S.; Chittaganpitch, Malinee; Badarch, Darmaa; Ellis, Joanna; Fasce, Rodrigo; Herring, Belinda L.; Herve, Kadjo; Hirve, Siddhivinayak; Li, Yan; Pisareva, Maria; Moen, Ann; Naguib, Amel; Palekar, Rakhee; Potdar, Varsha; Siqueira, Marilda Mendonça; Treurnicht, Florette K.; Tivane, Almiro; Venter, Marietjie; Wairagkar, Niteen; Zambon, Maria; Zhang, Wenqing

doi:10.1111/irv.12771

Cited by 6 publications

(6 citation statements)

References 23 publications

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“…We should learn from past failures like the suptavumab trial 11 . Current programs include the WHO Global RSV Surveillance program 34 (Mozambique, Sierra Leone, South Africa, Argentina, Brazil, Canada, Chile, Egypt, Russia, the UK, India, Thailand, Australia, Mongolia) and the OUTSMART program (the USA) 35 . We demonstrated that almost all global RSV B strains collected between 2015 and 2018 reported amino acid mutations in the suptavumab target epitope sequence.…”

Section: Discussionmentioning

confidence: 94%

A systematic review on global RSV genetic data: Identification of knowledge gaps

Langedijk

Harding

Konya

et al. 2021

Reviews in Medical Virology

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Respiratory syncytial virus (RSV) is a major health problem. A better understanding of the geographical and temporal dynamics of RSV circulation will assist in tracking resistance against therapeutics currently under development. Since 2015, the field of RSV molecular epidemiology has evolved rapidly with around 20-30 published articles per year. The objective of this systematic review is to identify knowledge gaps in recent RSV genetic literature to guide global molecular epidemiology research. We included 78 studies published between 2015 and 2020 describing 12,998 RSV sequences of which 8,233 (63%) have been uploaded to GenBank. Seventeen (22%) studies were performed in low-and middle-income countries (LMICs), and seven (9%) studies sequenced whole-genomes. Although most reported polymorphisms for monoclonal antibodies in clinical development (nirsevimab, MK-1654) have not been tested for resistance in neutralisation essays, known resistance was detected at low levels for the nirsevimab and palivizumab binding site. High resistance was found for the suptavumab binding site. We present the first literature review of an enormous amount of RSV genetic data. The need for global monitoring of RSV molecular epidemiology becomes increasingly important in evaluating the effectiveness of monoclonal antibody candidates as they reach their final stages of clinical development. We have identified the following three knowledge gaps: whole-genome data to study global RSV evolution, data from LMICs and data from global surveillance programs.

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Section: Discussionmentioning

confidence: 94%

A systematic review on global RSV genetic data: Identification of knowledge gaps

Langedijk

Harding

Konya

et al. 2021

Reviews in Medical Virology

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“…Therefore, mAbs can show sustained efficacy during long-term clinical use, provided they are specific for a stable epitope of RSV (nirsevimab binding epitopes: amino acids 62–69, 196–212). Nevertheless, ongoing molecular surveillance of RSV globally is key, with current initiatives including the WHO Global RSV Surveillance program, the OUTSMART, and INFORM programs ( Figure 2 ) ( 123 – 125 ).…”

Section: Considerations Of the Different Strategies For Protecting Al...mentioning

confidence: 99%

RSV Prevention in All Infants: Which Is the Most Preferable Strategy?

et al. 2022

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Respiratory syncytial virus (RSV) causes a spectrum of respiratory illnesses in infants and young children that may lead to hospitalizations and a substantial number of outpatient visits, which result in a huge economic and healthcare burden. Most hospitalizations happen in otherwise healthy infants, highlighting the need to protect all infants against RSV. Moreover, there is evidence on the association between early-life RSV respiratory illness and recurrent wheezing/asthma-like symptoms As such, RSV is considered a global health priority. However, despite this, the only prevention strategy currently available is palivizumab, a monoclonal antibody (mAb) indicated in a subset of preterm infants or those with comorbidities, hence leaving the majority of the infant population unprotected against this virus. Therefore, development of prevention strategies against RSV for all infants entering their first RSV season constitutes a large unmet medical need. The aim of this review is to explore different immunization approaches to protect all infants against RSV. Prevention strategies include maternal immunization, immunization of infants with vaccines, immunization of infants with licensed mAbs (palivizumab), and immunization of infants with long-acting mAbs (e.g., nirsevimab, MK-1654). Of these, palivizumab use is restricted to a small population of infants and does not offer a solution for all-infant protection, whereas vaccine development in infants has encountered various challenges, including the immaturity of the infant immune system, highlighting that future pediatric vaccines will most likely be used in older infants (>6 months of age) and children. Consequently, maternal immunization and immunization of infants with long-acting mAbs represent the two feasible strategies for protection of all infants against RSV. Here, we present considerations regarding these two strategies covering key areas which include mechanism of action, “consistency” of protection, RSV variability, duration of protection, flexibility and optimal timing of immunization, benefit for the mother, programmatic implementation, and acceptance of each strategy by key stakeholders. We conclude that, based on current data, immunization of infants with long-acting mAbs might represent the most effective approach for protecting all infants entering their first RSV season.

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“…One of the aims of the initial phase of the global surveillance was to evaluate and standardise WHO recommended and other existing RSV molecular tests to enable the accurate detection of RSV by laboratories in all six WHO regions. To achieve this, in 2016, the first External Quality Assessment exercise for the molecular detection of RSV was successfully developed, launched, and completed by the 14 participating national laboratories 4 . Following the successful implementation of Phase I in 2018, this was expanded to 26 countries in Phase II, each with a national laboratory participating in the Global RSV surveillance Program (Table S1).…”

Section: Introductionmentioning

confidence: 99%

“…To achieve this, in 2016, the first External Quality Assessment exercise for the molecular detection of RSV was successfully developed, launched, and completed by the 14 participating national laboratories. 4 Following the successful implementation of Phase I in 2018, this was expanded to 26 countries in Phase II, each with a national laboratory participating in the Global RSV surveillance Program (Table S1 ). This study describes the second of the WHO External Quality Assessments (EQA) performed during 2019–2020 for the molecular detection of RSV.…”

Section: Introductionmentioning

confidence: 99%

Results from the second WHO external quality assessment for the molecular detection of respiratory syncytial virus, 2019–2020

Williams

Jackson

Barr

et al. 2023

Influenza Resp Viruses

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Background External quality assessments (EQAs) for the molecular detection of human respiratory syncytial virus (RSV) are necessary to ensure the standardisation of reliable results. The Phase II, 2019–2020 World Health Organization (WHO) RSV EQA included 28 laboratories in 26 countries. The EQA panel evaluated performance in the molecular detection and subtyping of RSV‐A and RSV‐B. This manuscript describes the preparation, distribution, and analysis of the 2019–2020 WHO RSV EQA. Methods Panel isolates underwent whole genome sequencing and in silico primer matching. The final panel included nine contemporary, one historical virus and two negative controls. The EQA panel was manufactured and distributed by the UK National External Quality Assessment Service (UK NEQAS). National laboratories used WHO reference assays developed by the United States Centers for Disease Control and Prevention, an RSV subtyping assay developed by the Victorian Infectious Diseases Reference Laboratory (Australia), or other in‐house or commercial assays already in use at their laboratories. Results An in silico analysis of isolates showed a good match to assay primer/probes. The panel was distributed to 28 laboratories. Isolates were correctly identified in 98% of samples for detection and 99.6% for subtyping. Conclusions The WHO RSV EQA 2019–2020 showed that laboratories performed at high standards. Updating the composition of RSV molecular EQAs with contemporary strains to ensure representation of circulating strains, and ensuring primer matching with EQA panel viruses, is advantageous in assessing diagnostic competencies of laboratories. Ongoing EQAs are recommended because of continued evolution of mismatches between current circulating strains and existing primer sets.

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Results from the WHO external quality assessment for the respiratory syncytial virus pilot, 2016‐17

Abstract: This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

Cited by 6 publications

References 23 publications

A systematic review on global RSV genetic data: Identification of knowledge gaps

A systematic review on global RSV genetic data: Identification of knowledge gaps

RSV Prevention in All Infants: Which Is the Most Preferable Strategy?

Results from the second WHO external quality assessment for the molecular detection of respiratory syncytial virus, 2019–2020

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