Safety and immunogenicity of novel modified vaccinia Ankara-vectored RSV vaccine: A randomized phase I clinical trial.

Respiratory disease caused by RSV infection is recognized as a severe public health issue in infants, young children and elderly with no specific treatment option. Vaccination may be the most effective strategy to combat this highly infectious virus although no vaccine has been approved. The novel vaccine candidate MVA-BN-RSV encodes RSV surface proteins F and G (subtypes A, B) as well as internal proteins N and M2 in the MVA-BN viral vector backbone to provide broad protection against RSV. This was a first in human study to investigate safety, reactogenicity and immunogenicity of MVA-BN-RSV. Sixty-three participants were allocated to 3 groups: adult (18-49 years) low (1 × 107 TCID50) or high (1 × 108 TCID50) dose and older adult (50-65 years) high dose. Participants in each group were randomized in a 6:1 ratio to receive 2 doses of MVA-BN-RSV or placebo 4 weeks apart and were monitored for 30 weeks. All participants completed the study, receiving both doses. No serious AEs or AEs of special interest were reported. The most common AEs were injection site pain (56% in the combined high dose groups, 17% in the low dose group). MVA-BN-RSV induced robust T cell responses covering all 5 inserts with fold increases ranging from 1.8 to 3.8. Higher and broader responses were observed in the high dose groups (83% responders to at least 3 peptide pools in the combined high dose groups compared to 63% in the low dose group). Moderate but consistent humoral responses were observed against A and B RSV subtypes (up to approximately 2-fold increases in the high dose groups). No differences were observed between the adult and the older adult groups in safety, reactogenicity or immunogenicity. The study demonstrated that the well tolerated MVA-BN-RSV vaccine candidate induces broad cellular and humoral immune responses, warranting further development.

[Facilitating environment for dementia patients--the Pixel study]. / Environnement contenant chez la personne âgée démente--Etude Pixel.

UNLABELLED: Caregivers of demented outpatients can suffer from poor health, are often anguished and unable to cope with the cared patient, and this burden can generate frailty. OBJECTIVES: This survey attempted to determine the psychological parameters and effective capability influence of the caregiver's Quality of Life (QoL) and vulnerability, and measured the consequences of their alteration. METHODS: 4 categories of situations were studied, according to the angst and coping capability of caregivers. Caregiver's QoL and vulnerability were assessed in these situations. Data were related to the socio-demographic data of both patients and their principal caregivers, and to the patients' medical and therapeutic data. RESULTS: 1,410 and 10 patients diagnosed with dementia who lived at home with their principal caregivers were recruited for this survey. Angst and inability to cope with patients alter caregivers' QoL and was correlated to their vulnerability. Female caregivers were often in these situations, had a poorer QoL and were more vulnerable than men. Caregivers anguished and/or nab to cope with the cared patient were less satisfied with their own care and did not enjoy their relationships with their patients. Caregivers with psychological difficulties and failure to cope had to deal with nutritional difficulties with the demented patient. DISCUSSION: Caregivers' QoL and vulnerability, are related to angst and inability to cope with patients. We could imagine that both patients and caregivers would benefit by taking care of carers.