Human vaccines & immunotherapeutics
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Hum Vaccin Immunother · Jan 2015
LetterThe future of immunization policies in Italy and in the European Union: The Declaration of Erice.
On December 2014 the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) of the European Union adopted the Council Conclusions on "Vaccinations as an effective tool in public health," a crucial step to strengthen EU action supporting Member States (MS) to implement effective immunization policies and programs. As a contribution to the ongoing pan-European discussion and to the Italian commitment to stay at the forefront of promoting vaccination policies, the Erice Declaration was drafted by Italy's best experts in the field of immunization to transpose to the national level the goals set by the EPSCO Conclusions. The aim of the current letter is to present to the broader international audience the Italian perspective as a case study to assess different immunization policy models, challenges and priorities.
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Hum Vaccin Immunother · Jan 2015
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialComparative immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine administered according to 2- and 3-dose schedules in girls aged 9-14 years: Results to month 12 from a randomized trial.
This observer-blind study (clinicaltrials.gov NCT01462357) compared the immunogenicity and safety of 2 doses of the HPV-16/18 AS04-adjuvanted vaccine (HPV-16/18(2D)) vs. 2 or 3 doses of the HPV-6/11/16/18 vaccine (HPV-6/11/16/18(2D) and HPV-6/11/16/18(3D)) in healthy girls aged 9-14 y. Girls were randomized (1:1:1) to receive HPV-16/18(2D) at months (M) 0,6 (N = 359), HPV-6/11/16/18(2D) at M0,6 (N = 358) or HPV-6/11/16/18(3D) at M0,2,6 (N = 358). The primary objective was non-inferiority/superiority of HPV-16/18 antibodies by ELISA for HPV-16/18(2D) vs. ⋯ Frequencies of HPV-16/18-specific T-cells and B-cells were in similar ranges between groups. Reactogenicity and safety were in line with the known profile of each vaccine. In conclusion, superior HPV-16/18 antibody responses were elicited by 2 doses of the HPV-16/18 AS04-adjuvanted vaccine compared with 2 or 3 doses of the HPV-6/11/16/18 vaccine in girls (9-14 years).
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Hum Vaccin Immunother · Jan 2015
Randomized Controlled TrialEfficacy profile of a bivalent Staphylococcus aureus glycoconjugated vaccine in adults on hemodialysis: Phase III randomized study.
In a previous study in end-stage renal disease (ESRD) hemodialysis patients, a single dose of Staphylococcus aureus type 5 and 8 capsular polysaccharides (T5/T8) conjugated to nontoxic recombinant Pseudomonas aeruginosa exotoxin A investigational vaccine showed no efficacy against S. aureus bacteremia 1 year post-vaccination, but a trend for efficacy was observed over the first 40 weeks post-vaccination. Vaccine efficacy (VE) of 2 vaccine doses was therefore evaluated. In a double-blind trial 3359 ESRD patients were randomized (1:1) to receive vaccine or placebo at week 0 and 35. ⋯ The vaccine induced a robust immune response and had an acceptable safety profile. Further investigation suggested possible suboptimal vaccine quality (manufacturing) and a need to expand the antigen composition of the vaccine. This study is registered at www.clinicaltrials.gov NCT00071214.
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Hum Vaccin Immunother · Jan 2015
ReviewVaccine-preventable diseases in humanitarian emergencies among refugee and internally-displaced populations.
Humanitarian emergencies may result in breakdown of regular health services including routine vaccination programs. Displaced populations including refugees and internally displaced persons are particularly susceptible to outbreaks of communicable diseases such as vaccine-preventable diseases (VPDs). Common VPDs encountered in humanitarian emergencies include measles, polio, and depending on geographical location, meningococcal meningitis, yellow fever, hepatitis A, and cholera. ⋯ Growing insecurity, as seen in the increasing number of targeted attacks on health workers in recent years, as well as destruction of cold chain and infrastructure for transportation of supplies, are creating new challenges in provision of life saving vaccines in conflict settings. Population displacement can also threaten global VPD eradication and elimination efforts. While highly effective vaccines and guidelines to combat VPDs are available, the trend of increasing number of humanitarian emergencies globally poses new and emerging challenges in providing vaccination among displaced populations.