Prevalence of stress, anxiety and depression in with Alzheimer caregivers

<p>Abstract</p> <p>Background</p> <p>Alzheimer's disease presents a social and public health problem affecting millions of Italians. Those affected receive home care from caregivers, subjected to risk of stress.</p> <p>The present investigation focuses on stress, anxiety and depression in caregivers.</p> <p>Methods</p> <p>Data on 200 caregivers and their patients were collected using a specific form to assess cognitive, behavioural, functional patient (MMSE, and ADL-IAD) and caregiver stress (CBI). The relationship between stress, depression and disease has been assessed by means of a linear regression, logistic analysis which reveals the relationship between anxiety, stress and depression and cognitive problems, age, the patient's income.</p> <p>Results</p> <p>The caregivers are usually female (64%), mean age of 56.1 years, daughters (70.5%), pensioners and housewives (30%), who care for the sick at home (79%). Of these, 53% had little time for themselves, 55% observed worsening of health, 56% are tired, 51% are not getting enough sleep. Overall, 55% have problems with the patient's family and/or their own family, 57% at work. Furthermore, 29% feel they are failing to cope with the situation as they wish to move away from home. The increase in the degree of anxiety and depression is directly proportional to the severity of the illness, affecting the patient (r = 0.3 stress and depression r = 0.4 related to CBI score). The memory disorders (OR = 8.4), engine problems (OR = 2.6), perception disorders (OR = 1.9) sick of the patient with Alzheimer's disease are predictive of caregiver stress, depression is associated with the presence of other disorders, mainly behavioural (OR = 5.2), low income (OR = 3.4), patients < 65 years of age (OR = 2.9).</p> <p>Conclusion</p> <p>The quality of life of caregivers is correlated with the severity of behavioural disorders and duration of the Alzheimer's disease. The severity of the disease plays an important role in reorganization of the family environment in families caring for patients not institutionalised. It is important to promote measures to soften the impact that the patient has on the caregiver, and that, at the same time, improves the quality of life of the patient.</p

Safety, Immunogenicity and Dose Ranging of a New Vi-CRM197 Conjugate Vaccine against Typhoid Fever: Randomized Clinical Testing in Healthy Adults

Typhoid fever causes more than 21 million cases of disease and 200,000 deaths yearly worldwide, with more than 90% of the disease burden being reported from Asia. Epidemiological data show high disease incidence in young children and suggest that immunization programs should target children below two years of age: this is not possible with available vaccines. The Novartis Vaccines Institute for Global Health developed a conjugate vaccine (Vi-CRM₁₉₇) for infant vaccination concomitantly with EPI vaccines, either starting at 6 weeks with DTP or at 9 months with measles vaccine. We report the results from a Phase 1 and a Phase 2 dose ranging trial with Vi-CRM₁₉₇ in European adults.Following randomized blinded comparison of single vaccination with either Vi-CRM₁₉₇ or licensed polysaccharide vaccines (both containing 25·0 µg of Vi antigen), a randomised observer blinded dose ranging trial was performed in the same center to compare three concentrations of Vi-CRM₁₉₇ (1·25 µg, 5·0 µg and 12·5 µg of Vi antigen) with the polysaccharide vaccine.All vaccines were well tolerated. Compared to the polysaccharide vaccine, Vi-CRM₁₉₇ induced a higher incidence of mild to moderate short lasting local pain. All Vi-CRM₁₉₇ formulations induced higher Vi antibody levels compared to licensed control, with clear dose response relationship.Vi-CRM₁₉₇ did not elicit safety concerns, was highly immunogenic and is therefore suitable for further clinical testing in endemic populations of South Asia.ClinicalTrials.gov NCT01123941 NCT01193907

High Yield Production Process for Shigella Outer Membrane Particles

Gram-negative bacteria naturally shed particles that consist of outer membrane lipids, outer membrane proteins, and soluble periplasmic components. These particles have been proposed for use as vaccines but the yield has been problematic. We developed a high yielding production process of genetically derived outer membrane particles from the human pathogen Shigella sonnei. Yields of approximately 100 milligrams of membrane-associated proteins per liter of fermentation were obtained from cultures of S. sonnei ΔtolR ΔgalU at optical densities of 30–45 in a 5 L fermenter. Proteomic analysis of the purified particles showed the preparation to primarily contain predicted outer membrane and periplasmic proteins. These were highly immunogenic in mice. The production of these outer membrane particles from high density cultivation of bacteria supports the feasibility of scaling up this approach as an affordable manufacturing process. Furthermore, we demonstrate the feasibility of using this process with other genetic manipulations e.g. abolition of O antigen synthesis and modification of the lipopolysaccharide structure in order to modify the immunogenicity or reactogenicity of the particles. This work provides the basis for a large scale manufacturing process of Generalized Modules of Membrane Antigens (GMMA) for production of vaccines from Gram-negative bacteria

Characterization of Citrobacter sp. line 328 as a source of Vi for a Vi-CRM197 glycoconjugate vaccine against Salmonella Typhi

Introduction: Salmonella enterica serovar Typhi is the causative agent of typhoid fever with over 22 million cases and over 200,000 deaths reported annually. A vaccine is much needed for use in young children and the Novartis Vaccines Institute for Global Health (NVGH) is developing a conjugate vaccine which targets S. Typhi Vi capsular polysaccharide. Methodology: Here we describe a method suitable for industrial scale production of the Vi antigen based on expression by a Citrobacter line. We optimized the production of Vi by selecting a suitable Citrobacter strain (Citrobacter 328) that yields high and stable expression of Vi in chemically defined medium under industrial-scale fermentation conditions. Results: Vi-CRM197 made using Vi from Citrobacter 328 elicited high anti-Vi antibody levels in mice and rabbits. Conclusions: Citrobacter 328 is a suitable strain for production of Vi for conjugate anti-Typhi vaccines. Being a BSL-1 organism, which grows in defined medium and stably produces high yields of Vi, it offers excellent potential for safe production of inexpensive vaccines for populations at risk of typhoid fever