Background The burden of herpes zoster (HZ) is significant worldwide, with millions affected and the incidence rising. Current literature has identified some risk factors for this disease; however, there is yet to be a comprehensive study that pools all evidence to provide estimates of risk. Therefore, the purpose of this study is to identify various risk factors, excluding immunosuppressive medication, that may predispose an individual to developing HZ. Methods The literature search was conducted in MEDLINE, EMBASE, and Cochrane Central, yielding case control, cohort, and cross-sectional studies that were pooled from January 1966 to September 2017. Search terms included the following: zoster OR herpe* OR postherpe* OR shingle* AND risk OR immunosupp* OR stress OR trauma OR gender OR ethnicity OR race OR age OR diabetes OR asthma OR chronic obstructive pulmonary disease OR diabetes. Risk ratios (RRs) for key risk factors were calculated via natural logarithms and pooled using random-effects modeling. Results From a total of 4417 identified studies, 88 were included in analysis (N = 3, 768 691 HZ cases). Immunosuppression through human immunodeficiency virus/acquired immune deficiency syndrome (RR = 3.22; 95% confidence interval [CI], 2.40–4.33) or malignancy (RR = 2.17; 95% CI, 1.86–2.53) significantly increased the risk of HZ compared with controls. Family history was also associated with a greater risk (RR = 2.48; 95% CI, 1.70–3.60), followed by physical trauma (RR = 2.01; 95% CI, 1.39–2.91) and older age (RR = 1.65; 95% CI, 1.37–1.97). A slightly smaller risk was seen those with psychological stress, females, and comorbidities such as diabetes, rheumatoid arthritis, cardiovascular diseases, renal disease, systemic lupus erythematosus, and inflammatory bowel disease compared with controls (RR range, 2.08–1.23). We found that black race had lower rates of HZ development (RR = 0.69; 95% CI, 0.56–0.85). Conclusions This study demonstrated a number of risk factors for development of HZ infection. However, many of these characteristics are known well in advance by the patient and clinician and may be used to guide discussions with patients for prevention by vaccination.

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and Switzerland) and on peer-reviewed publications through PubMed. For Italy and Spain, a prominent regional HTA was evaluated, Lombardy and Catalonia respectively. Over 350 HTA characteristics, attributes assessed and methodologies used were assessed. Results: Among 10 HTA systems evaluated, England & Wales (NICE), Netherlands (CVZ) and Poland (AOTM) use explicitly stated incremental cost-effectiveness ratio (ICER) thresholds of £20,000-£30,000/QALY, € 40,000/QALY and € 26,500/QALY respectively. Three markets use implicit ICER thresholds based on the cost-effectiveness studies of previously approved drugs/technologies. Seven HTA bodies involve the general public, 6 publish reports online, 5 review within 2-6 months, and 3 allow for some form of appeal. We describe the various characteristics, attributes, and methodologies by payer architypes across Europe and discuss the associated pros and cons. Numerous HTA bodies provide support during submission process but others lack important information in the public domain. ConClusions: HTA bodies vary significantly and can be categorized as ones using explicit ICER thresholds and ones using implicit ICER thresholds in addition to other factors. Understanding the nuances related to HTA evaluation processes in multiple countries regarding involvement the general public, duration of review process, and ability to appeal, methods of technology assessment, preference on active controls, or availability of submission support will help manufacturers plan accordingly.

Noncomparative studies can be viewed as acceptable clinical evidence by HTA agencies when these study designs are justifiable and when treatment effect can be convincingly demonstrated, but their use is currently limited.

Background: Epidemiological studies suggest that there is a link between pneumococcal infection and adverse cardiovascular outcomes such as myocardial infarction. Multiple studies have evaluated the protective effect of the 23-valent polysaccharide pneumococcal vaccination (PPV23), but results have varied. Therefore, a meta-analysis was conducted to summarize available evidence on the impact of PPV23 on cardiovascular disease. Methods: A literature search from January 1946 to September 2019 was conducted across Embase, Medline and Cochrane. All studies were included that evaluated PPV23 compared with a control (placebo, no vaccine or another vaccine) for any cardiovascular events, including: myocardial infarction (MI), heart failure and cerebrovascular events. Risk ratios (RRs) were pooled using random effects models. Results: Eighteen studies were included, with a total of 716,108 participants. Vaccination with PPV23 was associated with decreased risk of any cardiovascular event (RR: 0.91; 95% CI: 0.84À0.99), and MI (RR: 0.88; 95% CI: 0.79À0.98) in all age groups, with a significant effect in those aged !65 years, but not in the younger age group. Similarly, PPV23 vaccine was associated with significant risk reduction in all-cause mortality in all ages (RR: 0.78; 95% CI: 0.68À0.88), specifically in those aged !65 years (RR: 0.71; 95% CI: 0.60À0.84). A significant risk reduction in cerebrovascular disease was not observed following pneumococcal vaccination. Conclusions: Polysaccharide pneumococcal vaccination decreased the risk for some adverse cardiovascular events, specifically acute MI in the vaccinated population, particularly for those individuals aged !65 years. It would be highly beneficial to vaccinate the population who is at greater risk of cardiovascular diseases.

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Invasive pneumococcal disease and pneumococcal pneumonia cause substantial morbidity and mortality in the elderly. This review focuses on the immunogenicity, safety, efficacy and effectiveness data on the use of the 13-valent conjugate pneumococcal vaccine (PCV13) in adults. A MEDLINE literature search was performed from January 1946 to December 2017. Additional references were identified from a review of literature citations. All English-language randomized trials, observational studies and meta-analyses assessing the immunogenicity, efficacy, effectiveness and safety of PCV13 in adults were evaluated. Six randomized controlled studies evaluated immunogenicity and safety of PCV13 in adults and showed that the conjugated vaccine elicited a greater immune response to the majority of the 13 serotypes compared to the 23-valent polysaccharide pneumococcal vaccine (PPV23). Administering PCV13 prior to PPV23 elicits greater immune responses and multiple doses of PCV13 demonstrated modest advantage. PCV13 titers declined after a year but remained above baseline. A randomized clinical trial (CAPiTA) showed that PCV13 was effective in preventing community-acquired pneumonia (CAP) and vaccine-type invasive pneumococcal disease, but not any cause pneumonia. Safety data shows PCV13 elicits minor local reactions, such as pain at the injection site. Major side effects that were commonly reported included muscle fatigue and headache. Both local and systemic adverse events were comparable to PPV23. While PCV13 has a well-established immunogenicity and safety profile in adults, there is sparse data on sequential or multiple dosing, efficacy and effectiveness in adults. As there are few countries who have adopted PCV13 for routine adult immunization, there is a need to evaluate the effectiveness of PCV13 in a real-world setting.

Group B Streptococcus is a Gram-positive bacterium that typically colonizes 10–30% of pregnant women, causing chorioamnionitis, preterm birth, and stillbirth, as well as neonatal sepsis and meningitis with early-onset disease (EOD) or late-onset disease (LOD) due to ascending infection or transmission during delivery. While there are some differences between EOD and LOD in terms of route of transmission, risk factors, and serotypes, the only preventive approach currently is maternal intrapartum antibiotic prophylaxis (IAP) which will not be able to fully address the burden of the disease since this has no impact on LOD. Probiotics and immunization in pregnancy may be more effective than IAP for both EOD and LOD. There is mixed evidence of probiotic effects on the prevention of GBS colonization, and the data from completed and ongoing clinical trials investigating different GBS vaccines are promising. Current vaccine candidates target bacterial proteins or the polysaccharide capsule and include trivalent, tetravalent, and hexavalent protein–polysaccharide conjugate vaccines. Some challenges in developing novel GBS vaccines include the lack of a correlate of protection, the potential for serotype switching, a need to understand interactions with other vaccines, and optimal timing of administration in pregnancy to maximize protection for both term and preterm infants.