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Aldo Lorenzetti M.D, Internal Medicine & Hepatology, Milano - SIMEDET Delegate
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Modeling The Economic #Burden Of Adult #Vaccine-Preventable Diseases In The United States

http://m.content.healthaffairs.org/content/early/2016/10/07/hlthaff.2016.0462

These results not only indicate the potential economic benefit of increasing adult immunization uptake but also highlight the value of vaccines. Policies should focus on minimizing the negative externalities or spillover effects from the choice not to be vaccinated, while preserving patient autonomy
Efficacy and effectiveness of an rVSV-vectored #vaccine in preventing #Ebola virus disease: final results from the Guinea ring vaccination, open-label, cluster-randomised trial (Ebola Ça Suffit!)

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)32621-6/fulltext

The results add weight to the interim assessment that rVSV-ZEBOV offers substantial protection against Ebola virus disease, with no cases among vaccinated individuals from day 10 after vaccination in both randomised and non-randomised clusters.
Final efficacy, immunogenicity, and safety analyses of a nine-valent human #papillomavirus #vaccine in women aged 16–26 years: a randomised, double-blind trial
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)31821-4/abstract

Primary analyses of a study in young women aged 16–26 years showed efficacy of the nine-valent human papillomavirus (9vHPV; HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58) vaccine against infections and disease related to HPV 31, 33, 45, 52, and 58, and non-inferior HPV 6, 11, 16, and 18 antibody responses when compared with quadrivalent HPV (qHPV; HPV 6, 11, 16, and 18) vaccine.

Between Sept 26, 2007, and Dec 18, 2009, we recruited and randomly assigned 14 215 participants to receive 9vHPV (n=7106) or qHPV (n=7109) vaccine. In the per-protocol population, the incidence of high-grade cervical, vulvar and vaginal disease related to HPV 31, 33, 45, 52, and 58 was 0·5 cases per 10 000 person-years in the 9vHPV and 19·0 cases per 10 000 person-years in the qHPV groups, representing 97·4% efficacy (95% CI 85·0–99·9). HPV 6, 11, 16, and 18 GMTs were non-inferior in the 9vHPV versus qHPV group from month 1 to 3 years after vaccination. No clinically meaningful differences in serious adverse events were noted between the study groups. 11 participants died during the study follow-up period (six in the 9vHPV vaccine group and five in the qHPV vaccine group); none of the deaths were considered vaccine-related.

Interpretation
The 9vHPV vaccine prevents infection, cytological abnormalities, high-grade lesions, and cervical procedures related to HPV 31, 33, 45, 52, and 58. Both the 9vHPV vaccine and qHPV vaccine had a similar immunogenicity profile with respect to HPV 6, 11, 16, and 18. Vaccine efficacy was sustained for up to 6 years. The 9vHPV vaccine could potentially provide broader coverage and prevent 90% of cervical cancer cases worldwide
Comprehensive #vaccine design for #commensal disease progression
http://advances.sciencemag.org/content/3/10/e1701797

Commensal organisms with the potential to cause disease pose a challenge in developing treatment options. Using the example featured in this study, pneumococcal disease begins with Streptococcus pneumoniae colonization, followed by triggering events that prompt the release of a virulent subpopulation of bacteria. Current vaccines focus on colonization prevention, which poses unintended consequences of serotype niche replacement. In this study, noncovalent colocalization of two classes of complementary antigens, one to prevent the colonization of the most aggressive S. pneumoniae serotypes and another to restrict virulence transition, provides complete vaccine effectiveness in animal subjects and the most comprehensive coverage of disease reported to date. As a result, the proposed vaccine formulation offers universal pneumococcal disease prevention with the prospect of effectively managing a disease that afflicts tens to hundreds of millions globally. The approach more generally puts forth a balanced prophylactic treatment strategy in response to complex commensal-host dynamics
4-Valent Human #Papillomavirus (4vHPV) #Vaccine in Preadolescents and Adolescents After 10 Years
http://pediatrics.aappublications.org/content/140/6/e20163947

For HPV types 6, 11, and 16, 89% to 96% of subjects remained seropositive through 10-years postvaccination. The preadolescents had 38% to 65% higher geometric mean titers at month 7, which remained 16% to 42% higher at 10 years compared with adolescents. No cases of HPV type 6, 11, 16, and 18–related diseases were observed. Ten subjects had a persistent infection of ≥6 months duration with vaccine-type HPV and 2 subjects had persistent infection for ≥12 months. No new serious adverse events were reported through 10 years.

CONCLUSIONS: A 3-dose regimen of the 4vHPV vaccine was immunogenic, clinically effective, and generally well tolerated in preadolescents and adolescents during 10 years of follow-up. These long-term findings support efforts to vaccinate this population against HPV before exposure
Interim Estimates of 2017–18 Seasonal #Influenza #Vaccine 

Effectiveness — United States, February 2018


https://www.cdc.gov/mmwr/volumes/67/wr/mm6706a2.htm?s_cid=mm6706a2_w



So far this season, influenza A(H3N2) viruses have predominated, but other influenza viruses are also circulating. Based on data from 4,562 children and adults with acute respiratory illness enrolled during November 2, 2017–February 3, 2018, at five study sites with outpatient medical facilities in the United States, the overall estimated effectiveness of the 2017–18 seasonal influenza vaccine for preventing medically attended, laboratory-confirmed influenza virus infection was 36%.
#Vaccine waning and #mumps re-emergence in the United States

http://stm.sciencemag.org/content/10/433/eaao5945


A mathematical model of mumps transmission confirmed the central role of waning immunity to the vaccine in the re-emergence of mumps cases. Outbreaks from 2006 to the present among young adults, and outbreaks in the late 1980s and early 1990s among adolescents, aligned with peaks in mumps susceptibility of these age groups predicted to be due to loss of vaccine-derived protection. In contrast, evolution of mumps virus strains escaping immune pressure would be expected to cause a higher proportion of cases among children, not adolescents and young adults as observed. Routine use of a third vaccine dose at 18 years of age, or booster dosing throughout adulthood, may be a strategy to prevent mumps re-emergence and should be assessed in clinical trials
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Phase 2b Controlled Trial of M72/AS01E #Vaccine to Prevent #Tuberculosis

https://www.nejm.org/doi/full/10.1056/NEJMoa1803484

A total of 1786 participants received M72/AS01E and 1787 received placebo, and 1623 and 1660 participants in the respective groups were included in the according-to-protocol efficacy cohort. A total of 10 participants in the M72/AS01E group met the primary case definition (bacteriologically confirmed active pulmonary tuberculosis, with confirmation before treatment), as compared with 22 participants in the placebo group (incidence, 0.3 cases vs. 0.6 cases per 100 person-years). The vaccine efficacy was 54.0% (90% confidence interval CI, 13.9 to 75.4; 95% CI, 2.9 to 78.2; P=0.04). Results for the total vaccinated efficacy cohort were similar (vaccine efficacy, 57.0%; 90% CI, 19.9 to 76.9; 95% CI, 9.7 to 79.5; P=0.03). There were more unsolicited reports of adverse events in the M72/AS01E group (67.4%) than in the placebo group (45.4%) within 30 days after injection, with the difference attributed mainly to injection-site reactions and influenza-like symptoms. Serious adverse events, potential immune-mediated diseases, and deaths occurred with similar frequencies in the two groups.

CONCLUSIONS
M72/AS01E provided 54.0% protection for M. tuberculosis–infected adults against active pulmonary tuberculosis disease, without evident safety concerns
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Approaches, Progress, and Challenges to Hepatitis #C #Vaccine Development

https://www.gastrojournal.org/article/S0016-5085(18)35035-2/fulltext?mobileUi=0

Risk factors for hepatitis C virus (HCV) infection vary, and there were an estimated 1.75 million new cases worldwide in 2015. The World Health Organization aims for a 90% reduction in new HCV infections by 2030. An HCV vaccine would prevent transmission, regardless of risk factors, and significantly reduce the global burden of HCV-associated disease. Barriers to development include virus diversity, limited models for testing vaccines, and our incomplete understanding of protective immune responses. Although highly effective vaccines could prevent infection altogether, immune responses that increase the rate of HCV clearance and prevent chronic infection may be sufficient to reduce disease burden.

Adjuvant envelope or core protein and virus-vectored non-structural antigen vaccines have been tested in healthy volunteers who are not at risk for HCV infection; viral vectors encoding non-structural proteins are the only vaccine strategy to be tested in at-risk individuals. Despite development challenges, a prophylactic vaccine is necessary for global control of HCV.
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#Vaccine-Preventable Diseases in Hospitalized Patients With Inflammatory #Bowel Disease: A Nationwide Cohort Analysis

https://academic.oup.com/ibdjournal/advance-article-abstract/doi/10.1093/ibd/izz093/5487145?redirectedFrom=fulltext

Inflammatory bowel disease (IBD) entails a higher risk of infections, including those that could be prevented with immunizations. Current Advisory Committee on Immunization Practices and American College of Gastroenterology vaccine recommendations for patients with IBD are based on low levels of evidence.

The most common VPDs among patients with IBD were herpes zoster virus (HZV) (34.9%) and hepatitis B virus (31.6%), followed by influenza (22.1%). Pneumococcal pneumonia (9.1%) and hepatitis A virus (2.4%) were less common. Inpatients with IBD were twice as likely to have HZV when compared to non-IBD inpatients (odds ratios OR = 2.30 95% CI, 2.06–2.58, P < 0.0001) This finding was consistent for every study year. Pneumococcal pneumonia OR = 0.62 (95% CI, 0.52–0.74), P < 0.0001 and influenza OR = 0.72 (95% CI, 0.63–0.81), P < 0.0001 were significantly lower in the IBD population. There was no difference for other VPDs.

Conclusions
HZV was the most frequent VPD in IBD inpatients. Patients with IBD have a higher rate of hospital admissions with HZV and a lower rate of pneumococcal pneumonia and influenza admissions when compared with non-IBD patients. For other VPDs, patients with IBD have the same rate of admission as the general population.
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A Phase 2 Study Evaluating the Safety, Tolerability, and Immunogenicity of Two 3-Dose Regimens of a #Clostridium difficile #Vaccine in Healthy US Adults Aged 65 to 85 Years

https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciz153/5498282

Clostridium difficile causes toxin-mediated nosocomial diarrhea and community-acquired infections; no preventive vaccine is licensed.

The 200-μg dose level elicited higher immune responses than the 100-µg dose level across regimens. Compared with the day regimen, the month regimen induced stronger and more persistent immune responses that remained elevated 12 months after dose 3. Responses peaked at month 7 (month regimen) and day 37 (day regimen). LRs (primarily injection site pain) were more frequent in vaccine recipients than controls; SE frequency was similar across groups. More related AEs were reported in the day regimen group than the month regimen group..

Conclusions
The C. difficile vaccine was safe, well tolerated, and immunogenic in healthy US adults aged 65–85 years. Immune responses were particularly robust in the 200-μg month regimen group. These results support continued vaccine development.
#Influenza #vaccine effectiveness 2019-2020 interim estimates

Annual vaccination against seasonal influenza is recommended for all U.S. persons aged ≥6 months. Effectiveness of seasonal influenza vaccine varies by season.

What is added by this report?

According to data from the U.S. Influenza Vaccine Effectiveness Network on 4,112 children and adults with acute respiratory illness during October 23, 2019–January 25, 2020, the overall estimated effectiveness of seasonal influenza vaccine for preventing medically attended, laboratory-confirmed influenza virus infection was 45%.

What are the implications for public health practice?

Vaccination remains the best way to protect against influenza and its potentially serious complications. CDC continues to recommend influenza vaccination while influenza viruses are circulating in the community.

https://bit.ly/2HLgnN2
An Immunomodulatory Therapeutic #Vaccine Targeting Oligomeric #Amyloid
https://2medical.news/2020/11/06/an-immunomodulatory-therapeutic-vaccine-targeting-oligomeric-amyloid-%CE%B2/

Background:Aging is considered the most important risk factor for Alzheimer’s disease (AD). Recent research supports the theory that immunotherapy targeting the “oligomeric” forms of amyloid-β (Aβ) may halt the progression of AD. However, previous clinical trial of the vaccine against Aβ, called AN1792, was suspended due to cases of meningoencephalitis in patients. Objective:To develop a peptide sensitized dendritic cells (DCs) vaccine that would target oligomer …
Humoral Response to the Pfizer BNT162b2 #Vaccine in Patients Undergoing Maintenance #Hemodialysis
https://2medical.news/2021/04/17/humoral-response-to-the-pfizer-bnt162b2-vaccine-in-patients-undergoing-maintenance-hemodialysis/

Coronavirus disease 2019 (COVID-19) is associated with higher morbidity and mortality in patients on maintenance hemodialysis. Patients on dialysis tend to have a reduced immune response to infection or vaccination. We aimed to assess, for the first time to the best of our knowledge, the humoral response following vaccination with the BNT162b2 vaccine in patients on maintenance hemodialysis and the factors associated with it. Design, …