Perez-Vilar S.,Vaccine Research |
Diez-Domingo J.,Vaccine Research |
Lopez-Lacort M.,Vaccine Research |
Martinez-Ubeda S.,Vaccine Research |
And 2 more authors.
BMC Infectious Diseases | Year: 2015
Background: Although rotavirus vaccines have been licensed in Spain for over 8 years, they are not funded by its public health systems. The analysis of their effectiveness in the Valencia Region could better inform decisions about potential inclusion in the official immunization schedule. Our aim was to assess the effectiveness of Rotarix® (RV1) and RotaTeq® (RV5) against rotavirus hospitalizations. Methods: We conducted a retrospective cohort study using the region's health care databases, among resident children aged <3 years covered by the National Health System, during January 2007-June 2012. We compared two cohorts of vaccinated children: the first included children who received at least one dose of a rotavirus vaccine, and the second included children who were not vaccinated with rotavirus vaccines but received at least one dose of a pneumococcal vaccine, another licensed but non-funded vaccine. The main outcome was rotavirus hospitalization, either laboratory-confirmed (confirmed) or codified as rotavirus (probable). Rotavirus vaccine effectiveness (RVE) by vaccine brand was assessed using Cox proportional hazards models. Results: The study included 78,281 rotavirus and 96,643 pneumococcal vaccinees. Adjusted RVE against probable or confirmed rotavirus hospitalizations was 86% (95% CI: 78-91%) and 88% (95% CI: 81-92%) for a complete series of RV1 and RV5 respectively. Conclusions: Both rotavirus vaccines were over 85% effective against rotavirus hospitalization among young children. The high effectiveness shown argues in favor of their inclusion in the official schedule. Additional information on rotavirus vaccine safety, duration of protection, and benefit-risk will also be needed to inform such deliberations. © 2015 Pérez-Vilar et al.; licensee BioMed Central.
The recent launch of multiple major US cancer initiatives has infused cash into immunotherapy, one of the most promising new methods of cancer treatment. But researchers warn that the money may be wasted without concrete plans to coordinate the programmes. “There’s a lack of overt leadership, and in the absence of a logical strategy we have a tendency to throw plates of spaghetti against the wall and hope it sticks,” says Ira Mellman, vice-president of cancer immunology at the biotechnology company Genentech in South San Francisco, California. The broadest programme is the US government’s National Cancer Moonshot, which hopes to receive US$1 billion by next year for 8 areas of cancer research. Immunotherapy, which recalibrates the body’s own immune defence against cancer, is among them. It “is poised to be a critical part of our nation’s anticancer strategy”, the project’s leader, US vice-president Joe Biden, said last week at the annual meeting of the American Association for Cancer Research (AACR) in New Orleans, Louisiana. An advisory panel will release more-detailed plans for the government programme in June. Meanwhile, three privately funded immunotherapy research projects are gearing up: the $250-million Parker Institute for Cancer Immunotherapy, funded by Sean Parker, co-founder of the music-file-sharing company Napster, and announced on 13 April; a $125-million Immunotherapy Center at Johns Hopkins University in Baltimore, Maryland, unveiled in March; and the Cancer MoonShot 2020 Program, announced in January by biotechnology billionaire Patrick Soon-Shiong. This sudden proliferation of cancer initiatives is reminiscent of the spate of brain-research projects launched in the past few years — some of which have foundered through poor leadership. Europe’s Human Brain Project, for instance, almost ran aground after a series of top-down decisions alienated the neuroscience community. By contrast, the US BRAIN Initiative set priorities after consulting with neuroscientists, and awarded grants through a conventional peer-reviewed process, ensuring community acceptance. Now cancer researchers are left wondering how their moonshots will proceed. At the AACR meeting, Biden said that he had met representatives of many cancer-funding projects. “Why is all of that being done separately?” he asked scientists in the audience, noting that progress is accelerated by collaboration. The privately funded initiatives are more concerned with meeting their own goals — and satisfying their funders — than with coordinating efforts in the field. “I don’t see my role as trying to answer this larger question about how does this all fit together,” says Jeffrey Bluestone, chief executive of the Parker Institute. “I’m focused on how to make sure what we do is impactful for patients.” But Douglas Lowy, acting director of the US National Cancer Institute (NCI), which is coordinating the government moonshot, notes an overlap with the leadership of the various projects. Soon-Shiong, Bluestone and leaders of immunotherapy initiatives at Johns Hopkins and the University of Texas MD Anderson Cancer Center in Houston are on the government initiative’s advisory panel. And on 18 April, the Biden moonshot launched a website to solicit research ideas. The aim, Lowy says, is to ensure that research areas recommended by the advisory panel do not duplicate topics being covered by the private initiatives. There is wide agreement on major questions regarding immunotherapy, however. For instance, researchers don’t understand why the approach works in only 15–20% of patients. Combining immunotherapies, and studying what distinguishes patients who respond, could make treatments more effective. Pharmaceutical companies are already developing new drugs and testing therapies in combination. Philip Gotwals, executive director of oncology research at the Novartis Institutes for BioMedical Research in Cambridge, Massachusetts, estimates that industry has spent upwards of $1 billion on the field. But scientists see a lack of basic cancer immunology research, even in the new programmes. “Many of these initiatives are moving forward ideas that are already out there,” says David Raulet, faculty director of the Immunotherapeutics and Vaccine Research Initiative at the University of California, Berkeley, which began in March. Many researchers are looking to the Biden project to make a big investment in basic cancer immunology and to address broader barriers to research, such as data hoarding. Gotwals, for instance, notes that the results of industry-sponsored clinical trials now under way could help other companies to decide which approaches to test, but that results are typically not made public until 9–12 months after a trial ends. Companies are reluctant to share data before then, both to comply with regulatory requirements and to protect their intellectual property. “It’s not trivial to figure out how to make that work,” Gotwals says. Biden seems to be hearing that message. At the AACR meeting, he said that data sharing often comes up when he speaks to scientists about the moonshot. Lowy says that the NCI is already planning to open a Genomic Data Commons in June to host detailed information on cancer patients. Sharing data collected in company-sponsored clinical trials is trickier because patients must give informed consent. In the meantime, the government moonshot faces a major hurdle: its funding is at the mercy of legislators who may be loath to give US President Barack Obama a victory in his last year in office. “It will be very difficult for us to initiate all of the programmes that we’re looking forward to the blue-ribbon panel recommending if there isn’t funding,” Lowy says.
Prevato M.,University of Siena |
Taddei A.R.,University of Tuscia |
Nandi A.,Vaccine Research |
Montomoli E.,University of Siena |
And 2 more authors.
PLoS ONE | Year: 2015
Antibodies (Ab) to neuraminidase (NA) play a role in limiting influenza infection and might help reduce the disease impact. The most widely used serological assay to measure functional anti-NA immune responses is the Enzyme-Linked Lectin Assay (ELLA) which relies on hemagglutinin (HA) mismatched virus reassortants, or detergent treated viruses as the NA source to overcome interference associated with steric hindrance of anti-HA Ab present in sera. The difficulty in producing and handling these reagents, which are not easily adapted for screening large numbers of samples, limits the routine analysis of functional anti-NA Ab in clinical trials. In this study, we produced influenza lentiviral pseudoparticles (PPs) containing only the NA antigen (NA-PPs) with a simple two-plasmid co-transfection system. NA-PPs were characterized and tested as an innovative source of NA in the NA inhibition (NI) assay. Both swine A/California/07/2009 (H1N1) and avian A/Turkey/Turkey/01/2005 (H5N1) N1s within NA-PPs retained their sialidase activity and were specifically inhibited by homologous and N1 subtype-specific, heterologous sheep sera. Moreover, A/California/07/2009 N1-PPs were a better source of NA compared to whole live and detergent treated H1N1 viruses in ELLA, likely due to lack of interference by anti-HA Ab, and absence of possible structural modifications caused by treatment with detergent. This innovative assay is safer and applicable to all NAs. Taken together, these results highlight the potential of NA-PPs-based NI assays to be developed as sensitive, flexible, easy to handle and scalable serological tests for routine NA immune response analysis. © 2015 Prevato et al.This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Breva L.P.,Vaccine Research |
Domingo J.D.,Vaccine Research |
Martinez Beneito M.T.,Foundation for the Promotion of Health and Biomedical Research in the Valencian Region |
Barbera J.P.,Vaccine Research
Vaccine | Year: 2015
Objective: To develop a method to estimate vaccination coverage using both a computerized vaccine registry with an unknown underreporting rate and a seroprevalence study. A real example of a meningococcal C conjugate vaccine (MCCV) coverage estimation is studied to illustrate the proposed methodology. Methods: We reviewed the Vaccine Information System of Valencia (Sistema de Información Vacunal, SIV) for the MCCV status of 1430 subjects aged 3-29 years as part of a seroprevalence study. When MCCV was not registered in SIV, subjects were classified into three groups (MCCV non-registered, no vaccination records and missing information) depending on the registry of other vaccines. A Bayesian model was developed to ascertain the percentage of MCCV-vaccinated subjects based on the meningococcal C seroprotection levels from the seroprevalence study. Results: The seroprotection levels in subjects with no MCCV registered in SIV (358) were similar to those in subjects with MCCV registered (1072). This indicated a large proportion of vaccinated subjects with no MCCV registered. The estimated vaccine coverage was over 80% in all age groups, except >22 years, where it was 67.6% (95% CI: [54.0-80.4]), which corresponded to those aged over 13 years at the time of the catch-up campaign. An underreporting rate of 23.5-73.4%, depending on the age group, was estimated in those vaccinated in the 2002 catch-up campaign. Conclusion: The Bayesian model allowed for a more realistic estimation of MCCV uptake. In this example, we quantified the underreporting of a vaccine registry, especially occurring during a catch-up campaign that occurred at the establishment of the registry. © 2015 .