Search results
Found 2819 matches for
Dr Samantha Vanderslott and Dr Seilesh Kadambari discuss their collaborative approach to providing ethnic minority groups with information on vaccines.
Antibiotic use attributable to RSV infections during infancy - an international prospective birth cohort study
Background Early-life antibiotic use impacts microbiome composition and contributes to the emergence of antimicrobial resistance. Despite respiratory syncytial virus (RSV) being a leading cause of acute respiratory infections (ARI), accurate estimates of antibiotic use attributable to RSV are lacking. Objectives To assess RSV-associated antibiotic use during the first year of life. Patients and methods The RESCEU birth cohort study followed healthy term infants, born (n = 9154) between 1 July 2017 and 31 July 2020 from five European countries, to identify RSV-ARI hospitalizations during infancy. In a nested cohort (n = 993), we performed active RSV surveillance by collecting nasal swabs in case of ARI symptoms during RSV seasons (October-April). Antibiotic use during hospitalization was identified through chart review, while outpatient data were collected via parental questionnaires. Results In the total cohort, antibiotics were used in 22.8% of RSV hospitalizations (33/145) and 62.5% of RSV intensive care admissions (5/8). In the nested cohort, antibiotics were used in 5.2% of any-severity RSV-ARI (13/250) and 9.9% of medically attended RSV-ARI (13/131). This results in an estimated incidence of 1.3% (95%CI: 0.8-2.0) of healthy term infants receiving ≥1 course of antibiotics associated with RSV infection in their first year, with an incidence rate of 1.1 RSV-associated antibiotic prescriptions per 1000 infant-months (95%CI: 0.6-1.9). As such, RSV accounts for 22.9% of antibiotic prescriptions for ARI during RSV seasons. Conclusions One in 77 healthy term infants receives antibiotics during RSV infection before their first birthday. Real-world evidence is needed to establish the impact of RSV immunization on antibiotic use during infancy.
Two distinct subpopulations of human stem-like memory T cells exhibit complementary roles in self-renewal and clonal longevity.
T stem cell-like memory cells (TSCM cells) are considered to be essential for the maintenance of immune memory. The TSCM population has been shown to have the key properties of a stem cell population: multipotency, self-renewal and clonal longevity. Here we show that no single population has all these stem cell properties, instead the properties are distributed. We show that the human TSCM population consists of two distinct cell subpopulations which can be distinguished by the level of their CD95 expression (CD95int and CD95hi). Crucially, using long-term in vivo labelling of human volunteers, we establish that these are distinct populations rather than transient states of the same population. These two subpopulations have different functional profiles ex vivo, different transcriptional patterns, and different tissue distributions. They also have significantly different TREC content indicating different division histories and we find that the frequency of CD95hi TSCM increases with age. Most importantly, CD95hi and CD95int TSCM cells also have very different dynamics in vivo with CD95hi cells showing considerably higher proliferation but significantly reduced clonal longevity compared with CD95int TSCM. While both TSCM subpopulations exhibit considerable multipotency, no single population of TSCM cells has both the properties of self-renewal and clonal longevity. Instead, the "stemness" of the TSCM population is generated by the complementary dynamic properties of the two subpopulations: CD95int TSCM which have the property of clonal longevity and CD95hi TSCM which have the properties of expansion and self-renewal. We suggest that together, these two populations function as a stem cell population.
Respiratory Syncytial Virus-related Community Chronic Obstructive Pulmonary Disease Exacerbations and Novel Diagnostics: A Binational Prospective Cohort Study.
Rationale: Respiratory syncytial virus (RSV) is a common global respiratory virus that is increasingly recognized as a major pathogen in frail older adults and as a cause of chronic obstructive pulmonary disease (COPD) exacerbations. There is no single test for RSV in adults that has acceptable diagnostic accuracy. Trials of RSV vaccines have recently shown excellent safety and efficacy against RSV in older adults; defining the frequency of RSV-related community infections and COPD exacerbations is important for vaccine deployment decisions. Objectives: This prospective study aimed to establish the frequency of outpatient-managed RSV-related exacerbations of COPD in two well-characterized patient cohorts using a combination of diagnostic methods. Methods: Participants were recruited at specialist clinics in London, United Kingdom, and Groningen, the Netherlands, beginning in 2017 and observed for three consecutive RSV seasons, during exacerbations, and at least twice yearly. RSV infections were detected by RT-PCR and serologic testing. Measurements and Main Results: A total of 377 patients with COPD attended 1,999 clinic visits and reported 310 exacerbations. There were 27 RSV-related exacerbations (8.7% of the total); of these, seven were detected only by PCR, 16 only by serology, and four by both methods. Increases in RSV-specific Nucleoprotein antibody were as sensitive as those in the antibody to Pre-Fusion or Post-Fusion for serodiagnosis of RSV-related exacerbations. Conclusions: RSV is associated with 8.7% of outpatient-managed COPD exacerbations in this study. Antibodies to RSV Nucleoprotein may have diagnostic value and are potentially important in a vaccinated population. The introduction of vaccines that prevent RSV is expected to benefit patients with COPD.
Serum and mucosal antibody-mediated protection and identification of asymptomatic respiratory syncytial virus infection in community-dwelling older adults in Europe.
INTRODUCTION: Respiratory syncytial virus (RSV) causes acute respiratory tract infection (ARTI) and reinfects adults throughout life, posing a risk for hospitalization in older adults (>60 years) with frailty and comorbidities. METHODS: To investigate serum and mucosal antibodies for protection against RSV infections, baseline serum samples were compared for RSV-pre- and -post-fusion (F) binding, and RSV-A2 neutralizing IgG antibodies between symptomatic RSV-ARTI (N = 30), non-RSV (RSV negative) ARTI (N = 386), and no ARTI (N = 338). Mucosal RSV-pre-F IgA and IgG levels, as well as serum RSV-G IgG antibodies, were analyzed to determine their association with protection from symptomatic RSV-ARTI in a subset study. RESULTS: Using a receiver operating characteristic (ROC) analysis, we established thresholds of 1.4- to 1.6-fold change (FC) for RSV-pre-F and -post-F, and RSV-A2 neutralizing IgG antibodies, respectively, enabling the identification of asymptomatic RSV cases with high sensitivity and specificity (>80% and >90%, respectively). As a result, serum RSV-pre-F, RSV-G IgG, and mucosal pre-F binding IgA antibodies showed correlations with protection against symptomatic RSV infection. RSV-pre-F IgG antibodies were correlated with protection from RSV infections irrespective of the symptoms. DISCUSSION: This study provides insights into antibody-mediated protection for symptomatic RSV infection in a community-dwelling older-adult population and establishes a threshold to identify asymptomatic RSV infection using a data-driven approach.
Antifungal Use in Immunocompromised Children in Europe: A 12-Week Multicenter Weekly Point Prevalence Survey (CALYPSO)
We prospectively analyzed antifungal use in immunocompromised children through a multicenter 12-week weekly point-prevalence survey in 31 hematology-oncology (HO) and hematopoietic stem cell/solid organ transplant (HSCT/SOT) units of 18 hospitals in 11 European countries. All patients hospitalized and receiving systemic antifungals were included. Ward policies, and weekly ward/patient data were collected. All 21 HO and 10 HSCT/SOT units had prophylaxis policies for high-risk patients (27/31 used azoles, 14/31 echinocandins and 15/31 liposomal amphotericin B [LAMB]). Among 572 courses recorded, prophylaxis was indicated in 439/572 (77%) and treatment in 133/572 (62/133 empirical, 43/133 pre-emptive, 28/133 targeted). Among patients receiving prophylaxis, 56% belonged to the non-high-risk group. Most common reasons for empirical, pre-emptive and targeted treatment were antibiotic-resistant febrile neutropenia (52%), abnormalities on chest-CT with/without positive galactomannan (77%) and candidiasis (82%), respectively. Fluconazole and LAMB were the most frequently prescribed agents both for prophylaxis (31%, 21%) and treatment (32%, 23%). Underdosing of micafungin for treatment in 50% of prescriptions and of fluconazole for treatment and prophylaxis in 70% of cases was noticed. In conclusion, most antifungal prescribing was for prophylaxis, with fluconazole being the main antifungal prescribed. Inadequate doses of antifungal prescribing and prophylaxis of non-high-risk patients could be targets for improvement.
Communicating about paediatric infectious diseases at the beginning of the 20th century.
The Charta of paediatric infectious diseases, which was printed in Athens, Greece in 1912, contains instructions for school students on the prevention of paediatric infectious diseases occurring in Greece at the beginning of the 20th century. It consists of four sections: i) The official circular of the Department of the School of Hygiene of the Hellenic Ministry of Education on the protection of school students from acute infectious diseases signed by the minister on January 31, 1912; ii) an introductory section on the definition of infectious diseases, the modes of their transmission and the conditions required for the inactivation of microbial activity; iii) a section with general preventative measures against paediatric infectious diseases; and iv) a section with information and specialized measures against specific paediatric infectious diseases. It also contains colourful images of children with different infectious diseases, including smallpox, measles, diphtheria, varicella, eye trachoma and other infectious diseases involving the skin. The Charta of paediatric infectious diseases is exhibited at the Museum of School Students' Life in Aliveri, on the island of Euboea in Greece and was recently reprinted in the context of the 10th workshop on paediatric virology organized by the Institute of Paediatric Virology on November 9, 2024.
180-day efficacy of nirsevimab against hospitalisation for respiratory syncytial virus lower respiratory tract infections in infants (HARMONIE): a randomised, controlled, phase 3b trial.
BACKGROUND: Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract infection and hospitalisations in infants worldwide. The primary analyses of HARMONIE showed that nirsevimab reduced infant hospitalisations due to RSV-associated lower respiratory tract infection through the RSV season. This analysis aims to evaluate nirsevimab's efficacy at 180 days after dosing, a period exceeding the typical 5-month RSV season. METHODS: HARMONIE is an ongoing, open-label, parallel arm, randomised, controlled, phase 3b study conducted in France, Germany, and the UK. Infants aged 12 months or younger, born at a gestational age of at least 29 weeks, were randomly assigned (1:1) to receive either a single intramuscular dose of nirsevimab (50 mg for children <5 kg or 100 mg for children ≥5 kg) or standard care (without RSV prophylaxis) before or during their first RSV season. Randomisation was electronically done, stratified by country and age-group. The primary efficacy endpoint for this analysis was the incidence of hospitalisations due to RSV-associated lower respiratory tract infection up to 180 days after nirsevimab administration or randomisation in all randomised participants. Safety up to 365 days following nirsevimab administration was also assessed. This trial is ongoing and registered with ClinicalTrials.gov, number NCT05437510. FINDINGS: Between Aug 8, 2022, and Feb 28, 2023, 8057 infants were randomly assigned to either the nirsevimab group (n=4038) or the standard care group (n=4019). The median age at randomisation was 4·00 months (IQR 1·0-7·0; range 0·0-12·0, and 4195 (52·1%) were male and 3862 (47·9%) were female. Up to 180 days, 12 (0·3%) of 4038 infants in the nirsevimab group and 68 (1·7%) of 4019 infants in the standard care group had been hospitalised for RSV-associated lower respiratory tract infection, corresponding to a nirsevimab efficacy of 82·7% (95% CI 67·8-91·5; p<0·0001). Most participants experienced grade 1 (2759 [68·7%] of 4016 in the nirsevimab group; 2696 [67·1%] of 4018 in the standard care group) or grade 2 (1447 [36·0%] of 4016 in the nirsevimab group; 1436 [35·7%] of 4018 in the standard care group) treatment-emergent adverse events, and no apparent safety concerns were raised up to 365 days after dosing. INTERPRETATION: Nirsevimab offers consistent and sustained protection against hospitalisation due to RSV-associated lower respiratory tract infection for at least 6 months. This finding provides global health systems greater flexibility when implementing nirsevimab, providing substantial benefit in the ongoing effort to reduce the burden of infant RSV and the potential wider public health value. FUNDING: Sanofi and AstraZeneca.
Recent advances in the prevention and treatment of respiratory syncytial virus disease.
Respiratory syncytial virus (RSV) is associated with considerable healthcare burden; as such, prevention and treatment of RSV have long been considered a priority. Historic failures in RSV vaccine development had slowed the research field. However, the discovery of the conformational change in the RSV fusion protein (F) has led to considerable advancements in the field. The RSV pharmaceutical landscape has drastically changed in recent years with successful trials of both vaccines and second-generation mAbs leading to licensing and roll-out of these agents in several countries. RSV preventative and therapeutic measures will likely have a significant impact on RSV-related morbidity and mortality. However, there are still gaps in the protection that these immunizations offer that should be addressed. Many unanswered questions about RSV infection dynamics and subsequent disease should be a focus of ongoing research. This review discusses the currently licensed RSV pharmaceuticals and others that have recently progressed to clinical trials.
Antiviral Treatment and Risk of Hearing Loss in Asymptomatic and Mild Symptomatic Infants With Congenital Cytomegalovirus.
BACKGROUND: To assess hearing outcomes at 24 months of age in infants with mild congenital cytomegalovirus (cCMV) infection, depending on whether they have received antiviral treatment or not. METHODS: A retrospective study within the European Registry of Children with cCMV was performed. Included children had cCMV diagnosed in utero/in the first 21 days of life, with normal physical examination, alanine aminotransferase <80 U/L and platelets >100,000 cs/mm 3 and absence of hearing loss (HL) at birth. Cranial ultrasound (cUS) and/or cranial magnetic resonance imaging was normal or with minor findings (isolated lenticulostriate vasculopathy and/or germinolysis/caudothalamic or subependymal cysts, and/or focal/multifocal white matter involvement). The main outcome was the presence of HL at 24 months of age. RESULTS: One hundred ninety-six patients met inclusion criteria. A total of 34.7% received antiviral treatment with valganciclovir/ganciclovir. Children treated had lower gestational age, birth weight and head circumference, and maternal primary infection was less frequent. Among treated children, 21.3% presented minor findings in cUS versus 6.3% in nontreatment group ( P = 0.003). Nine patients (4.6%) developed HL at 24 months. Among children with HL, 20% presented minor findings in cUS versus 11.3% in non-HL group ( P = NS). HL rate was similar in treated and nontreated groups (4.6% vs. 6.3%; P = 0.6). CONCLUSIONS: One-third of the children were treated with antivirals and infants with minor neuroimaging findings at birth were more likely to receive antiviral. There were no differences in the prevalence of HL at 2 years of age between treated and not-treated children. Minor neuroimaging findings were not clearly associated with an increased risk of delayed onset HL.
In Vitro Characterization of the Immune Response to an Epitope Ensemble Vaccine Against Rhinovirus in Pediatric Asthma and Adults With Chronic Obstructive Pulmonary Disease: Protocol for an Observational and Exploratory Study.
BACKGROUND: Human rhinoviruses (HRVs) are the leading cause of upper respiratory tract infections, responsible for over half of all such infections. Infection rates among young children can reach as high as 8-12 episodes per year. While HRV infections typically result in mild common colds, they can also lead to more severe respiratory conditions, often in conjunction with bacterial coinfections. In addition, HRVs are implicated in the exacerbation of obstructive respiratory diseases, including asthma and chronic obstructive pulmonary disease (COPD). T-cell responses play a crucial role in the immune defense against HRV. However, in patients with obstructive respiratory diseases, altered or dysregulated T-cell responses to HRV may not only fail to efficiently eliminate the virus but can also exacerbate inflammation and airway remodeling. Therefore, a deeper understanding of T-cell-mediated responses in the context of HRV infection, especially in vulnerable populations like those with COPD, is critical. It can provide new insights into mechanisms of both protection and disease exacerbation, potentially guiding the development of targeted therapies or vaccines that enhance protective immunity while minimizing harmful inflammation. OBJECTIVE: This study aims to (1) determine the population-wide coverage of HRV-specific T-cell responses, (2) characterize HRV-specific T-cell recall responses in disease cohorts compared to age-match healthy controls, and (3) identify biomarkers of protection and susceptibility within disease cohorts through a comparative analysis. METHODS: Participants with asthma and those with COPD, aged 5-15 and 40-70 years, respectively, will be recruited alongside healthy age-matched controls. Peripheral blood samples will be collected following informed consent from adult participants and from parents or guardians of minors, as applicable. Clinical, demographic, immunological, and genetic responses will be assessed both prior to and following in vitro stimulation with a pool of HRV-specific T-cell epitopes. Flow cytometry and functional assays will be used to analyze T-cell responses to HRV epitopes in the context of obstructive respiratory diseases. RESULTS: This study was funded in January 2023 by the Ministry of Science and Innovation of Spain. The primary aim of the study was achieved within the same year. Recruitment for the secondary and tertiary aims is currently ongoing. Preliminary findings highlight the potential significance of HRV-specific T-cell responses in individuals with asthma and those with COPD. A detailed characterization of these immune responses will provide critical insights into host-pathogen interactions and may serve as a foundation for the development of effective T-cell-based vaccines or immunotherapies targeting HRV. CONCLUSIONS: Here, we present an ethically approved study protocol for an observational and exploratory study investigating a novel epitope-based vaccine targeting HRV, with a focus on pediatric asthma and adult COPD cohort populations. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/73383.
The respiratory microbiome is linked to the severity of RSV infections and the persistence of symptoms in children.
Respiratory syncytial virus (RSV) is the leading cause of infant respiratory infections and hospitalizations. To investigate the relationship between the respiratory microbiome and RSV infection, we sequence nasopharyngeal samples from a birth cohort and a pediatric case-control study (Respiratory Syncytial virus Consortium in Europe [RESCEU]). 1,537 samples are collected shortly after birth ("baseline"), during RSV infection and convalescence, and from healthy controls. We find a modest association between baseline microbiota and the severity of consecutive RSV infections. The respiratory microbiota during infection clearly differs between infants with RSV and controls. Haemophilus, Streptococcus, and Moraxella abundance are associated with severe disease and persistence of symptoms, whereas stepwise increasing abundance of Dolosigranulum and Corynebacterium is associated with milder disease and health. We conclude that the neonatal respiratory microbiota is only modestly associated with RSV severity during the first year of life. However, the respiratory microbiota at the time of infection is strongly associated with disease severity and residual symptoms.
Respiratory viral detection in children hospitalized with pneumonia during periods of major population disruptions in Nepal, 2014-2018.
BACKGROUND: Respiratory viruses commonly cause pneumonia in children. We aimed to identify respiratory viral nucleic acids in the nasopharynx of children admitted with pneumonia from 2014 to 2018, a period including a major earthquake (April 2015), PCV10 introduction (August 2015), and a fuel shortage (October 2015 to March 2016). METHODS: Children 2 months to 14 years admitted to Patan Hospital between March 2014 and February 2018 with a clinical diagnosis of pneumonia had nasopharyngeal swabs collected and tested with a multiplex panel for the presence of genetic material from 23 respiratory pathogens. RESULTS: Of 1343 children with pneumonia, 974 (72.5%) had the nucleic acids of at least one respiratory virus in the nasopharynx. The median age of children with any viral genetic material detected was lower than those without (1.18, IQR: 0.59-2.39 years; versus 2.01 years, IQR: 0.81-4.34 years; p<0.001). Commonly detected viral nucleic acids included those of RSV (21.0%), rhino/enterovirus (30.8%), and parainfluenza (7.4%). The odds of detecting any respiratory viral genetic material in children with pneumonia increased by 1.88 (95% confidence interval: 1.15, 3.06) in the year after the earthquake, when there were several aftershocks and a fuel crisis, relative to other periods and accounting for other potential confounding factors. CONCLUSIONS: These findings highlight the importance of viral diagnostics in pediatric pneumonia and suggest that public health measures addressing environmental conditions during disasters might help reduce respiratory infections.
Prediction and characterisation of the human B cell response to a heterologous two-dose Ebola vaccine.
Ebola virus disease (EVD) outbreaks are increasing, posing significant threats to affected communities. Effective outbreak management depends on protecting frontline health workers, a key focus of EVD vaccination strategies. IgG specific to the viral glycoprotein serves as the correlate of protection for recent vaccine licensures. Using advanced cellular and transcriptomic analyses, we examined B cell responses to the Ad26.ZEBOV, MVA-BN-Filo EVD vaccine. Our findings reveal robust plasma cell and lasting B cell memory responses post-vaccination. Machine-learning models trained on blood gene expression predicted antibody response magnitude. Notably, we identified a unique B cell receptor CDRH3 sequence post-vaccination resembling known Orthoebolavirus zairense (EBOV) glycoprotein-binding antibodies. Single-cell analyses further detailed changes in plasma cell frequency, subclass usage, and CDRH3 properties. These results highlight the predictive power of early immune responses, captured through systems immunology, in shaping vaccine-induced B cell immunity.
Understanding the interaction of upper respiratory tract infection with respiratory syncytial virus and Streptococcus pneumoniae using a human challenge model: a multicenter, randomized controlled study protocol.
BACKGROUND: Streptococcus pneumoniae (pneumococcus) and respiratory syncytial virus (RSV) are major causes of respiratory infections globally. Viral and bacterial co-infections are commonly observed in respiratory infections and there is evidence that these pathogens interact synergistically to evade host responses and lead to more severe disease. Notably, RSV seasonal outbreaks are associated with increased hospitalization and a subsequent peak in invasive pneumococcal disease cases, particularly in pediatric populations. Here, we summarize a protocol for a controlled human infection model aiming to evaluate pathogen interaction dynamics and immune responses in a combined pneumococcus and RSV model. The primary objective is to determine whether primary RSV challenge increases the risk of secondary pneumococcal colonization. METHODS: This is an open-label, multi-center, randomized controlled human co-infection study, inclusive of a pilot phase. Individuals will be randomized to primary inoculation with either pneumococcus (serotype 6B) or RSV (subtype RSV-A) intra-nasally on day 0 followed by a reciprocal challenge on day 7. During pilot phase A up to 10 participants will be monitored in an in-patient facility for 7-10 days following RSV-A challenge. If there are no safety concerns, we will then progress to an outpatient phase where participants will self-isolate at home. Clinical samples to be taken from participants include nasal swabs and washes for pathogen detection; and nasal cells, nasal lining fluid, and blood samples to examine mucosal and systemic immune responses. DISCUSSION: This work will lead to important scientific knowledge on the interaction and dynamics between pneumococcus and RSV. This knowledge could help inform pneumococcal and RSV vaccination strategies, particularly for groups at risk of developing severe pneumococcal and RSV disease. TRIAL REGISTRATION: The study is registered on ISRCTN (The UKs Clinical Study Registry). DOI https://doi.org/10.1186/ISRCTN12036902.
Placental transfer of SARS-CoV-2 antibodies in mother-neonate pairs: a prospective nested cohort study.
BACKGROUND: Newborns depend on the transfer of IgG across the placenta to acquire protection against pathogens. We assessed the placental transfer of SARS-CoV-2 antibodies, primarily derived from infection, from seropositive pregnant women enrolled in a pregnancy cohort in Kilifi, Kenya. METHODS: The study was nested within a prospective observational multi-country cohort study. All available paired maternal delivery and cord blood samples were selected. Maternal sera were tested for SARS-CoV-2 receptor binding domain (RBD) IgM/IgG total antibodies using the Wantai assay. For positive samples, maternal and corresponding cord blood samples were tested for SARS-CoV-2 IgG antibodies against the spike (anti-spike) and nucleocapsid proteins (anti-NCP) using ELISA kits from Euroimmun. RESULTS: A total of 492 (56.1%) out of 877 maternal delivery samples were positive for RBD IgM/IgG total antibodies. Of these, 416 (84.6%) were seropositive for either anti-NCP IgG, anti-spike IgG antibodies or both. A total of 412 out of 496 (83%) cord blood samples tested positive for either anti-NCP or anti-spike antibodies. The geometric mean ratio was 1.04 (95% CI: 0.90, 1.21), indicating no significant difference between the anti-spike IgG concentration in cord and maternal blood samples. The log-transformed maternal and cord blood anti-spike IgG concentrations showed a weak positive correlation (r = 0.364, n = 496, p
Roles and responsibilities of participants, researchers, and the media in the communication of vaccine trials: Experience from the United Kingdom's first COVID-19 vaccine trial.
BACKGROUND: The media have played an important part in presenting arguments for and against vaccination. The potential for the media to influence public attitudes to vaccines is becoming increasingly crucial to address. METHODS: To understand the differing roles and responsibilities in the communication of vaccine trials we draw insight from a retrospective study of 349 survey responses and 102 semi-structured interviews conducted in 2020 with participants in the United Kingdom's first-in-human clinical trial of the Oxford-AstraZeneca COVID-19 vaccine. RESULTS: We found that trial participants had mixed views as to whether their participation conferred responsibility to communicate more widely about their trial experiences. Some participants perceived themselves to have an altruistic obligation to communicate to the media about the trial, and others felt that those who did share their participation had 'attention-seeking' motives. When participants did speak out they preferred to do so anonymously. Frustration was also reported with sensationalised and false media stories. Social media was viewed as a means to accelerate misinformation or as a force for recruitment and public education about trials. Participants were pleased to see trial investigators and trial team playing prominent roles in the media and this instilled confidence in the vaccine and the trial. We discuss these evolving roles and responsibilities for trial communication, concentrating on the views of participants about experiences, opportunities, and risks. CONCLUSIONS: We argue that the pandemic has demonstrated the need for clinical trials to be made more transparent as a scientific practice that requires better public understanding and engagement. For high-profile vaccine trials we recommend; (1) explicit and comprehensive guidance aimed at all participants for interactions with the media; (2) prioritising having open and effectively expressed accounts of trial composition, processes, and participation; (3) offering support and a direct communication channel for journalists to report trials by utilising internal press officers to engage with journalists.