To assess the effects of behaviourally informed short message service (SMS) reminders on demand for human papillomavirus (HPV) immunisation.

Individually randomised, five-group, controlled parallel trial.

A country-wide trial in Georgia.

55 176 girls aged 10–12, the entire population of unvaccinated girls of this age in the country, for whom there existed caregiver contact details.

Girls were randomised into five arms (four with n=11 035, with one n=11 036). Caregivers of the girls in four of the arms (treatment groups) were sent different versions of an SMS reminder (SMSR), reminding them that the girl was due to receive the HPV vaccine. The control group was sent no SMSR.

The primary outcome was a girl’s HPV vaccination status at the end of the trial.

Girls and their caregivers were blinded to group assignment.

The number of participants analysed in the four treatment groups was 10,784, 10,802, 10,794 and 10,820, with 10 828 analysed in the control group.

Each of the SMSRs was more effective than the control (no reminder) in encouraging HPV vaccination. Girls whose caregiver(s) were sent version 3 had 65% greater odds of receiving the vaccine relative to the control group (OR=1.65; 95% CI 1.38 to 1.97). Among girls whose caregivers received version 1, version 2 and version 4 of the SMS, the odds of receiving the HPV vaccine were respectively 42% (OR=1.42; 95% CI 1.18 to 1.70), 34% (OR=1.34; 95% CI 1.12 to 1.61) and 35% (OR=1.35; 95% CI 1.13 to 1.62) higher compared with the girls in the control arm.

We find a positive and statistically significant effect for each version of the SMSR, relative to the control condition.

NCT05536674.

This study investigated the perceived clinicians’ roles in penicillin allergy assessment among medical staff in tertiary hospitals in China.

This was a multicentre cross-sectional survey.

The study was conducted at 89 tertiary hospitals in eastern and western China from March to May 2024.

A survey was conducted involving 8493 medical staff from tertiary hospitals in eastern and western China using multistage sampling.

A self-designed questionnaire was used to assess evaluation status of penicillin allergy assessment, including allergy history assessment and recording, skin test result evaluation during hospitalisation, allergic reaction recording at discharge and awareness of allergy assessment teams.

Among 8493 healthcare professionals (doctors 40.0%, nurses 56.3%, pharmacists 3.7%), significant gaps existed in penicillin allergy documentation: while 92.0% acknowledged the need to document specific drug names, only 66.2% practised this (nurses 62.2% vs pharmacists 82.0%, p

Currently, the assessment and recording methods for antimicrobial allergies by the medical staff of tertiary hospitals in China are not sufficiently accurate. Nurses play a key role in the assessment of antimicrobial allergies. Thus, medical staff, especially nurses, should receive more vigorous training, and structured assessment tools for antimicrobial allergies based on clinical decision support systems should be devised for them. Our findings also reiterate the need to establish penicillin allergy assessment teams at the hospital level.

The predisposition to food allergy development and the induction of allergen-specific immune responses appears to be initiated early in infancy. Early exposure to food allergens, such as peanut and cashew nut, via human milk is likely important in initiating oral tolerance and reducing risk of food allergy development. This trial aims to determine if the risk of developing peanut and cashew nut allergy during infancy can be reduced by a high peanut and cashew nut maternal diet during lactation.

This is a multisite, parallel, two-arm (1:1 allocation), single-blinded (outcome assessors, statistical analyst and investigators), randomised controlled trial. Target sample size is 4412 participants (2206 per group). Women (aged 18–50 years) with a singleton pregnancy, who are planning to breastfeed and do not have peanut and/or cashew nut allergies are eligible to participate. After obtaining written informed consent, participants are randomised to either a high peanut and cashew nut diet (at least 60 peanuts and 40 cashew nuts per week) or a low peanut and cashew nut diet (no more than 20 peanuts and 12 cashew nuts per week). Participants are asked to follow their allocated diet from birth to 6 months postnatal. Individual lactation consultant advice and support is provided as required. The study’s primary outcome is food challenge proven IgE-mediated peanut and/or cashew nut allergy during infancy (0–18 months). Key secondary outcomes include infant sensitisation to peanut and/or cashew nut. Analyses will be performed on an intention-to-treat basis according to a prespecified statistical analysis plan.

Ethical approval has been granted from the Western Australian Child and Adolescent Health Service Human Research Ethics Committee (approval number RGS0000006685). Trial results will be presented at scientific conferences and published in peer-reviewed journals.

Australian New Zealand Clinical Trials Registry (ACTRN ACTRN12624000134527)

Ebola virus disease remains a significant public health concern. For protection from Ebola virus, the main target populations are epidemiologically identified and often include healthcare workers and refugees. These target populations are also routinely offered vaccines for other vaccine-preventable diseases. However, concomitant use of rVSVG-ZEBOV-GP with other vaccines is not recommended, given the absence of data regarding its reactogenicity and antigen-specific immunogenicity profile when co-administered. The EbolaCov trial aims to inform whether rVSVG-ZEBOV-GP can be administered concurrent to a Pfizer–BioNTech COVID-19 booster dose without an unacceptable increase in reactogenicity and/or loss of humoral immunogenicity to Ebola vaccine antigen.

This is a single-centre, randomised, single-blinded, vaccine safety and immunogenicity study in healthy adults living in Rwanda. Seventy-two participants will be randomised in a 1:1 ratio to two study groups, the first receiving rVSVG-ZEBOV-GP with a placebo, the second group receiving rVSVG-ZEBOV-GP concurrently with a Pfizer–BioNTech COVID-19 booster dose. The primary outcome measures are quantitative serum anti-glycoprotein (GP) antibody responses, as measured by ELISA, 28 days after vaccination, and frequency and severity of adverse events in the 7 days following vaccination. Secondary outcome measures include day 28 and day 180 serum anti-GP and serum SARS-CoV-2 anti-spike protein-specific geometric mean antibody titres.

This trial was approved by the Rwanda National Ethics Committee (reference 442/2024) and the University of Birmingham (reference ERN_2661-Jun2024). All participants were required to provide written informed consent in accordance with good clinical practice. Dissemination of results will be through conference presentations and peer-reviewed publications.

Pan African Clinical Trials Registry (PACTR202407764378004) and ClinicalTrials.gov (NCT06587503)

Autoimmune disease can greatly affect pregnancy outcomes, leading to increased health risks for both mothers and fetuses. Vitiligo is a common chronic skin condition characterised by the loss of pigment. However, there is controversy regarding adverse pregnancy outcomes (APOs) associated with this condition. Our scoping review aims to explore and summarise the existing literature on pregnancy outcomes in patients with vitiligo.

This scoping review will follow the five-stage methodological framework introduced by Arksey and O’Malley. This stages approach encompasses the following stages: (a) identifying the research questions, (b) identifying relevant research studies, (c) selecting studies, (d) extracting and charting the data and (e) summarising, analysing and reporting the results. We will search two databases, PubMed and Scopus, for published literature up to January 2025 using keywords related to pregnancy outcomes and vitiligo. All retrieved articles will be organised using EndNote software. Two trained reviewers will complete title and abstract screening, full-text screening and data charting. The data will be presented using different strategies, including tables and graphs, to map pregnancy outcomes in patients with vitiligo.

The scoping review will not involve direct contact with humans or patients; therefore, ethical approval is not required for this protocol. The data analysis will focus on exploring APOs in patients with vitiligo. The results of this study will be published in peer-reviewed journals.

To develop a behavioural intervention package to support non-allergist healthcare workers (HCWs) to remove incorrect penA records from medical and surgical adult inpatients. This paper describes the development of the penicillin allergy de-labelling (PADL) intervention and the implementation intervention that will support non-allergist-delivered PADL.

We combined evidence-based, theory-based and person-based approaches. Qualitative research with healthcare professionals and patients explored barriers and enablers to implementation of the proposed PADL pathway. Key intervention design objectives and the key features of the implementation intervention required to achieve each objective were then developed and captured as guiding principles. We produced a logic model, integrating the theoretical domains framework to identify the behavioural influences on PADL and the behaviour change wheel to show how the implementation intervention is hypothesised to address the target behaviours. The implementation intervention package was then reviewed by stakeholders and topic experts for further refinement and optimisation. Finally, we outline how the implementation intervention will be evaluated.

Single-centre District General Hospital in the SW England servicing a rural community of 575 000 people without local allergy services.

HCWs reported PADL needed to be structured, standardised, evidence based and supported by hospital approved guidelines with easy to access patient information leaflets, supported by a sustained programme of education and training with named PADL leaders and visible PADL champions. Patients wanted a good explanation of the benefits and risks of testing and the benefits of having their ‘penA’ record removed. The identified HCW target behaviours were: taking a penA allergy focused history and to risk assess the patient’s penA history; to then either de-label the patient on history alone (direct de-label; DDL) or prescribe a direct oral challenge (DOC) dose; to perform baseline and post-test observations and counsel the patient on the risks of penA records and on the risks and the benefits of PADL. We identified barriers to target behaviours that we considered both important and modifiable, which included: lack of confidence in taking a penA focused history, PADL not viewed as a priority, low confidence with differentiating low-risk and high-risk penA histories, concerns about the safety of DOC, a requirement for senior support for nurses to deliver the observations and senior support for the other HCWs to deliver PADL, access to an expert for advice when required, a lack of PADL champions to promote PADL, and PADL not being supported by the organisation. The identified patient target behaviours were acceptance of the opportunity to be de-labelled via either DDL or DOC and willingness to take penicillin when prescribed. We developed intervention components to target the HCW and patient target behaviours which included: Education, expert advice made available from Infection specialists, a named PADL champion, hospital endorsed PADL guideline with necessary tools to enable PADL and patient information leaflets. The implementation intervention was further optimised through workshops with PADL researchers and stakeholders. The Consolidated Framework for Implementation Research outcome addendum was used to define both implementation intervention and PADL intervention outcomes.

We have developed a theory-based and stakeholder-developed implementation intervention to support inpatient PADL delivered by a multiprofession workforce. The intervention will be tested in a single hospital and scalability explored.

Systemic lupus erythematosus (SLE) is a chronic and complex multisystem autoimmune disease with high mortality. Telitacicept is a new strategy for the treatment of SLE, inhibiting the maturity, proliferation and differentiation of B cells, and thus, reduces disease activity. However, the effectiveness and safety of telitacicept in patients with SLE are not yet established.

Five English databases (Pubmed, Embase, Web of Science, Cochrane Central Register of Controlled Trials, Cumulative Index of Nursing and Allied Health Literature) and four Chinese databases (China National Knowledge Infrastructure, Wanfang Data, China Science and Technology Journal Database and Sinomed) will be searched from database inception to 1 June 2025. Two investigators will independently conduct study selection, data extraction and quality assessment. Outcomes include disease activity, incidence of flares, organ damage, several immune-related laboratory parameters and adverse events. Risk ratio with 95% CI and mean difference or standardised mean difference will be used as measures of effect sizes, in order to pool the data using either a random-effect model or fixed-effect model according to the heterogeneity of studies. Subgroup analysis and sensitivity analysis will be performed to explore the source of heterogeneity and evaluate the robustness of the results. We will use the Risk of Bias 2 tool and Risk of Bias In Non-Randomized Studies of Interventions tools to assess the quality of the included studies, and use the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) system to assess the certainty of evidence.

No ethical approval is required since this review is based on previously published studies. The findings of this study will be presented at international conferences or published in a peer-reviewed journal.

CRD42024558180.

The prevalence of food allergies, particularly IgE-mediated allergies, is rising in developed countries, with cashew nut allergy emerging as a significant public health concern due to its potential for severe anaphylaxis and frequent association with atopic disorders. Cashew nuts are among the most common allergens in Europe and Australia, often involving cosensitisation with pistachios, hazelnuts and other allergens. Diagnosis relies on clinical history, measurement of specific IgE (sIgE) levels, skin prick tests (SPT) and oral food challenges (OFCs). Current management strategies focus on allergen avoidance and emergency interventions, whereas oral immunotherapy (OIT) represents a promising approach to desensitisation. Recent studies, including the NUT CRACKER trial, have reported high desensitisation rates with cashew OIT, although these are associated with a risk of adverse events. This study introduces a novel randomised controlled trial aimed at evaluating the efficacy and safety of cashew immunotherapy in children.

This randomised, open-label, parallel-group trial, with a 2:1 allocation ratio, will be conducted at the Department of Paediatric Pneumology and Allergology, Medical University of Warsaw, Poland. Thirty-nine children, aged 4–17 years, with confirmed IgE-mediated cashew allergy via open OFC will be enrolled. Participants in the experimental group will undergo OIT, which involves gradually increasing doses of cashew protein up to a maintenance dose of 1200 mg. The duration of OIT will range from 12 to 60 weeks, depending on individual baseline tolerance. The control group will receive standard management, including strict cashew avoidance and emergency response strategies to accidental exposure, for 1 year.

The primary endpoint is to determine the proportion of participants tolerating a 4043 mg dose of cashew protein at the study’s end in the OIT group compared with the control group. Secondary outcomes include evaluating the safety profile of OIT, assessing changes in laboratory markers such as sIgE and IgG4 levels for cashew and the major cashew allergen Ana o 3, analysing basophil activation test responses and measuring changes in SPT wheal diameter at baseline and study completion.

The study has been approved by the Ethics Committee of the Medical University of Warsaw (approval number: KB/267/2023). Study findings will be published in peer-reviewed journals and presented at international conferences.

NCT06328504.