Human vaccines & immunotherapeutics
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The unprecedented dimensions of the 2014 Ebola epidemic which ravaged 3 West African countries have challenged public health response capacity and urged the availability of safe and effective vaccines. In this context, vectored vaccines already tested in animal models have undergone phase 1 studies in human beings and are now ready for efficacy evaluation in large scale trials. Health care workers and other frontline caregivers are likely to be the target population for both vaccine trials and vaccination campaigns. However, methodological and ethical issues should be considered in plans concerning the conduction of clinical trials and the possible use of licensed vaccines against Ebola.
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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
Phase II studies to select the formulation of a multivalent HPV L1 virus-like particle (VLP) vaccine.
Our objective was to develop a multivalent prophylactic HPV vaccine that protects against infection and disease caused by HPV16/18 (oncogenic types in existing prophylactic vaccines) plus additional oncogenic types by conducting 3 Phase II studies comparing the immunogenicity (i.e., anti-HPV6/11/16/18 geometric mean titers [GMT]) and safety of 7 vaccine candidates with the licensed quadrivalent HPV6/11/16/18 vaccine (qHPV vaccine) in young women ages 16-26. In the first study (Study 1), subjects received one of 3 dose formulations of an 8-valent HPV6/11/16/18/31/45/52/58 vaccine or qHPV vaccine (control). In Study 2, subjects received one of 3 dose formulations (termed low-, mid-, and high-dose formulations, respectively) of a 9-valent HPV6/11/16/18/31/33/45/52/58 vaccine (9vHPV vaccine) or qHPV vaccine (control). ⋯ Based on the totality of the results, the middle dose formulation of the 9vHPV vaccine was selected for Phase III evaluation. Each 0.5mL dose contains 30μg/40μg/60μg/40μg/20μg/20μg/20μg/20μg/20μg of HPV6/11/16/18/31/33/45/52/58 virus-like particles, and 500μg of amorphous aluminum hydroxyphosphate sulfate adjuvant. ClinicalTrials.gov numbers NCT00260039, NCT00543543, and NCT00551187.
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Hum Vaccin Immunother · Jan 2015
Surveillance and vaccination coverage of measles and rubella in Northern Italy.
Measles and rubella are infectious diseases and humans are the only reservoir of these infections. Effective vaccines are available with the potential for measles (MV) and rubella (RuV) virus eradication. According to the World Health Organisation guidelines, a national plan was approved in Italy in 2013 to achieve the MV/RuV elimination by 2015, and active MV/RuV integrated surveillance initiated. ⋯ From data obtained during our surveillance activity, there were no rubella cases, and 57.5% (46/80) collected samples were MV-positive by real-time RT-PCR. A fragment of the MV N gene was sequenced from 37 MV-positive samples; D8, D9, and B3 genotypes were detected. Data obtained retrospectively and from active surveillance underline the necessity to achieve and maintain high vaccination coverage and to improve surveillance and the effectiveness of healthcare actions.
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Despite the tremendous progress in controlling measles in China, there was measles outbreak in Beijing which was a result of cluster of unvaccinated people or people failure to vaccinate. In order to accelerate measles control efforts and achieve and high levels of measles immunity, it is helpful to implement more targeted management strategy.