Dose escalation study of a personalized peptide-based neoantigen vaccine (EVX-01) in patients with metastatic melanoma.

Background: Neoantigens can serve as targets for T cell-mediated antitumor immunity via personalized neopeptide vaccines. Interim data from our clinical study NCT03715985 showed that the personalized peptide-based neoantigen vaccine EVX-01, formulated in the liposomal adjuvant, CAF09b, was safe and able to elicit EVX-01-specific T cell responses in patients with metastatic melanoma. Here, we present results from the dose-escalation part of the study, evaluating the feasibility, safety, efficacy, and immunogenicity of EVX-01 in addition to anti-PD-1 therapy.

Uptake of signposting to web-based resources: pregnant women's use of a preventive web-based intervention.

Background: Signposting to web-based interventions is becoming increasingly popular in primary care. Most resources are focused on individuals with clinical problems, but less is known about the uptake of general practice (GP) signposted web-based interventions. GPs in Denmark are responsible for scheduled preventive care during pregnancy and the child's first five years.

Evaluation of the Danish version of the prenatal parental reflective functioning questionnaire in early pregnancy as a screening tool.

Parental reflective functioning (PRF) is the capacity to focus on feelings and experiences in oneself as a parent and in the child. Research has demonstrated that, the better the PRF the better outcomes for the child. This paper evaluated the Danish version of the prenatal parental reflective functioning questionnaire (P-PRFQ).

Association of self-reported mother-infant relationship with child and adolescent mental health.

Background: The quality of the relationship between mother and infant may have profound implications for the development of a child. Early indicators of psychological vulnerability may allow targeting of support for the child's cognitive, emotional and social development. A challenging mother-infant relationship could be one indicator of risk.

Family wellbeing in general practice: a study protocol for a cluster-randomised trial of the web-based resilience programme on early child development.

Background: Social, emotional and behavioural problems in early childhood are associated with increased risk for a wide range of poor outcomes associated with substantial cost and impact on society as a whole. Some of these problems are rooted in the early mother-infant relationship and might be prevented. In Denmark, primary health care has a central role in preventive care during pregnancy and the first years of the child's life and general practice provides opportunities to promote a healthy mother-infant relationship in early parenthood.

A pre-post intervention study: Knowledge among parents about child infections and antibiotic use facilitated by maternal and child health nurses.

Aims: To investigate parent's knowledge and beliefs of common infections and antibiotics in children before and after an educational intervention provided by maternal and child health nurses. Second, to investigate sociodemographic differences in parent's knowledge before and following the intervention.

Design: A prospective pre-post intervention study.

Mental well-being during stages of COVID-19 lockdown among pregnant women and new mothers.

Background: Pregnancy and early motherhood are sensitive times where epidemic disease outbreaks can affect mental health negatively. Countries and health care systems handled the pandemic and lockdowns differently and knowledge about how the COVID-19 pandemic affected the mental well-being of pregnant women and new mothers is limited and points in different directions.

Aim: To investigate symptoms of anxiety and depression in a population of pregnant women and new mothers in various stages of infection pressure and lockdown during the first 15 months of the COVID-19 pandemic in Denmark.

Personalized therapy with peptide-based neoantigen vaccine (EVX-01) including a novel adjuvant, CAF®09b, in patients with metastatic melanoma.

The majority of neoantigens arise from unique mutations that are not shared between individual patients, making neoantigen-directed immunotherapy a fully personalized treatment approach. Novel technical advances in next-generation sequencing of tumor samples and artificial intelligence (AI) allow fast and systematic prediction of tumor neoantigens. This study investigates feasibility, safety, immunity, and anti-tumor potential of the personalized peptide-based neoantigen vaccine, EVX-01, including the novel CD8 T-cell inducing adjuvant, CAF®09b, in patients with metastatic melanoma (NTC03715985).

Depression and anxiety symptoms in pregnant women in Denmark during COVID-19.

Aims: Maternal mental distress in pregnancy can be damaging to the mother's and child's physical and mental health. This study aimed to provide an insight into mental well-being of pregnant women in Denmark during COVID-19 by assessing symptoms of depression and anxiety.

Methods: Data from two cohorts of pregnant women recruited from Danish general practice were compared.

Native and foreign healthcare workers' knowledge of appropriate use of antibiotics: a prospective pre-post study in Danish nursing homes.

Aim: The aim was to determine the association between healthcare workers' (HCWs) country of birth and their knowledge of appropriate use of antibiotics, and whether the association changed after an educational intervention.

Background: Older residents in nursing homes have been recognized to receive excessively antibiotic treatments. HCWs often represent an important link between the older resident and the general practitioner prescribing the antibiotics, thus their knowledge of appropriate use of antibiotics is important.

Prime-Pull Immunization with a Bivalent M-Protein and Spy-CEP Peptide Vaccine Adjuvanted with CAF®01 Liposomes Induces Both Mucosal and Peripheral Protection from Mutant Streptococcus pyogenes.

Infections with and their sequelae are responsible for an estimated 18 million cases of serious disease with >700 million new primary cases and 500,000 deaths per year. Despite the burden of disease, there is currently no vaccine available for this organism. Here, we define a combination vaccine P*17/K4S2 comprising of 20-mer B-cell peptide epitopes, p*17 (a mutant derived from the highly conserved C3-repeat region of the M-protein), and K4S2 (derived from the streptococcal anti-neutrophil factor, Spy-CEP).

Pregnant women's concerns and antenatal care during COVID-19 lock-down of the Danish society.

Introduction: Pandemics are known to cause stress and anxiety in pregnant women. During the coronavirus disease 2019 (COVID-19) lockdown of the Danish society, pregnant women were considered to be at increased risk, and access to antenatal care changed.

Methods: On 8 April 2020A, a questionnaire was sent to 332 pregnant women previously sampled by general practitioners in two Danish regions.

Effects of parenting interventions for mothers with depressive symptoms and an infant: systematic review and meta-analysis.

Background: Postpartum depression is common in the perinatal period and poses a risk for the development of the infant and the mother-infant relationship. Infancy is a critical developmental period of life and supportive parenting is crucial for healthy development, however, the effects of interventions aimed at improving parenting among mothers with depression are uncertain.

Aims: To assess the effects of parenting interventions on parent-child relationship and child development among mothers with depressive symptoms with 0-12-month-old infants.

Effects of parenting interventions for at-risk parents with infants: a systematic review and meta-analyses.

Objectives: Infancy is a critical stage of life, and a secure relationship with caring and responsive caregivers is crucial for healthy infant development. Early parenting interventions aim to support families in which infants are at risk of developmental harm. Our objective is to systematically review the effects of parenting interventions on child development and on parent-child relationship for at-risk families with infants aged 0-12 months.

The surface charge of liposomal adjuvants is decisive for their interactions with the Calu-3 and A549 airway epithelial cell culture models.

One of the main reasons for the unmet medical need for mucosal vaccines is the lack of safe and efficacious mucosal adjuvants. The cationic liposome-based adjuvant system composed of dimethyldioctadecylammonium (DDA) bromide and trehalose 6,6'-dibehenate (TDB) is a versatile adjuvant that has shown potential for mucosal vaccination via the airways. The purpose of this study was to investigate the importance of the liposomal surface charge on the interaction with lung epithelial cells.