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Have Aliu,1–3 Carola Rask,1 Jens Brimnes,1 Thomas Lars Andresen2,3 1Immunology Department, In vivo Biology Team, ALK Abelló A/S, Hørsholm, 2Department of Micro- and Nanotechnology, Technical University of Denmark, 3Center for Nanomedicine and Theranostics, Technical University of Denmark, Kgs Lyngby, Denmark Abstract: Immunotherapy by sublingual administration of allergens provides high patient compliance and has emerged as an alternative to subcutaneous immunotherapy for the ­treatment of IgE-associated allergic diseases. However, sublingual immunotherapy (SLIT) can cause adverse events. Development of allergen delivery systems enabling more efficient delivery and hence lower allergen load might reduce the adverse events. In the present study, we have investigated neutral and cationic liposomes as delivery systems of ovalbumin (OVA), as a model allergen, in an OVA-induced allergic airway inflammation model. We investigated the liposome carriers’ ability to improve tolerance induction of antigens compared to the ­corresponding dose of free OVA. Mice were treated sublingually over 2 weeks with free or liposome encapsulated OVA followed by intraperitoneal injections and intranasal challenge. Mice sublingually treated with OVA-liposomes showed a significant reduction of airway eosinophilia and splenocyte proliferation in comparison to free OVA. A similar nonsignificant pattern was seen for OVA-specific IgE antibodies. In addition, reduced levels of interferon-γ and interleukin-5 were observed in spleen cell culture supernatants from OVA-liposome-treated mice compared to the sham-treated group. In conclusion, in vivo efficacy data showed that prophylactic SLIT with OVA-liposomes is significantly more effective in preventing allergic inflammation than the corresponding dose of free OVA. Keywords: sublingual immunotherapy, drug delivery, allergy, liposome

STUDY QUESTION Are there some characteristics that render individuals more susceptible to report menstrual changes following the Coronavirus disease 2019 (COVID-19) vaccination? SUMMARY ANSWER We found that 30% of menstruating women reported menstrual changes following COVID-19 vaccination and several potential risk factors including stress, vaccine concerns, severe COVID-19 infection, and immediate vaccine symptoms were associated with these reports. WHAT IS KNOWN ALREADY Studies suggest that COVID-19 vaccination might temporarily prolong menstrual cycle length by less than 1 day. Specific characteristics may trigger menstrual changes in temporal relation to the vaccination simply by chance or render women more vigilant to potential menstrual changes after being vaccinated. However, research investigating potential risk factors for reporting menstrual changes following COVID-19 vaccination is limited. STUDY DESIGN, SIZE, DURATION A population-based Danish cohort study. Data were collected from May 2021 to December 2021 as a part of the BiCoVac Cohort with the aim of examining non-specific effects following COVID-19 vaccination. The main study population included 13 648 menstruating women aged 16–65 years who completed all surveys, received their first dose of a COVID-19 vaccine during the data collection period, and completed questions related to their menstrual cycle. PARTICIPANTS/MATERIALS, SETTING, METHODS Potential risk factors included 14 biological, physical, or psychological measures. Information on most potential risk factors was self-reported and collected before the participants' first COVID-19 vaccination. Information about any menstrual change following COVID-19 vaccination was self-reported at the end of the data collection period. Logistic regression analyses were used to estimate crude and adjusted odds ratios (ORs) with 95% CIs for the association between each potential risk factor and reporting menstrual changes following COVID-19 vaccination. MAIN RESULTS AND THE ROLE OF CHANCE Any menstrual change following COVID-19 vaccination was reported by 30% of menstruating women. Most of the potential risk factors were associated with reports of menstrual changes following COVID-19 vaccination. In particular, higher odds were found among women who reported ≥5 immediate vaccine symptoms; OR 1.67 [1.50–1.86], had had a prior severe COVID-19 infection; OR 2.17 [1.40–3.35], had a high-stress level at baseline; OR 1.67 [1.32–2.10], or were concerned about COVID-19 vaccines prior to vaccination; OR 1.92 [1.50–2.45]. Lower odds were found among women with regular menstrual cycles using hormonal contraception; OR 0.71 [0.65–0.78]. LIMITATIONS, REASONS FOR CAUTION We were unable to address the causal effect of COVID-19 vaccination on the reported menstrual changes, as information about menstrual changes was not available among non-vaccinated women. WIDER IMPLICATIONS OF THE FINDINGS The study identified several potential risk factors for reporting menstrual changes following COVID-19 vaccination. Further studies are needed to establish causal associations and the clinical impact of self-reported menstrual changes. STUDY FUNDING/COMPETING INTEREST(S) The BiCoVac data collection was funded by TrygFonden (id-number: 153678). No competing interests are declared. TRIAL REGISTRATION NUMBER N/A. [ABSTRACT FROM AUTHOR]

The covid-19 pandemic has influenced children and parents worldwide. The pandemic has also been suggested to especially affect and exacerbate health anxiety (HA) symptoms in children and adolescents. However, there is limited understanding of the potential mechanisms challenges of families where parents themselves experience mental health issues such as high degree of HA symptoms.

Tina Hovgaard Lützen,1 Charlotte Ulrikka Rask,2,3 Oleguer Plana-Ripoll,4 Bodil Hammer Bech,1 Lene Wulff Krogsgaard,1 Nanna Rolving,5,6 Dorte Rytter1 1Research Unit for Epidemiology, Department of Public Health, Aarhus University, Aarhus C 8000, Denmark; 2Research Unit, Department of Child and Adolescent Psychiatry, Aarhus University Hospital, Aarhus N 8200, Denmark; 3Department of Clinical Medicine, Aarhus University, Aarhus N 8200, Denmark; 4National Centre for Register-Based Research, Department of Economics and Business Economics, Aarhus University, Aarhus V 8210, Denmark; 5University Clinic of Innovative Patient Pathways, Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg 8600, Denmark; 6DEFACTUM, Corporate Quality, Central Denmark Region, Aarhus N 8200, DenmarkCorrespondence: Tina Hovgaard Lützen Research Unit for Epidemiology, Department of Public HealthAarhus University, Bartholins Allé 2, Aarhus C 8000, DenmarkTel +45 22410722Email tina.lutzen@ph.au.dkAim: This study aimed to describe and compare general practitioner (GP) attendance patterns in the years surrounding HPV-vaccination among cases suspected to experience adverse events and their matched controls in order to determine if a potential larger change in GP attendance among cases was observed in temporal relation to vaccination.Methods: Register-based, matched case–control study. Cases were defined as women referred to specialized hospital settings (HPV-centers) for suspected adverse event between June 1st 2015 and December 31st 2015 (n=1458). Information on referral was obtained from the HPV-centers directly. Each case was matched with five controls on age at vaccination, region, time of first vaccine registration and total number of doses, resulting in a total study population of 8670 girls and women. Negative binomial regression analyses were used (i) to estimate mean yearly GP contacts among cases and controls, and (ii) to further investigate the relative difference in change in GP attendance following vaccination between cases and controls.Results: Overall, cases displayed higher GP attendance than controls from five years before vaccination up until five years after. Compared to controls, cases increased their GP attendance more in the years following HPV vaccination, corresponding to a 40% increase in the incidence rate ratios (IRR) from before to after vaccination (ratio-IRR = 1.40 [1.36; 1.44]). The change occurred in close proximity to vaccination, and the pattern was the same independently of the year of vaccination. However, for the later vaccination years cases displayed an additional increase in their GP attendance around time of extensive media attention.Conclusion: Girls and women being referred for suspected adverse events after HPV-vaccination changed their GP attendance pattern in close proximity to their first HPV-vaccination and not solely in temporal linkage to the onset of public debate.Keywords: HPV vaccination, general practice attendance, adverse effects, case–control