# name
Live virus vaccines based on a yellow fever vaccine backbone:  Standardized template with key considerations for a risk/benefit                 assessment

# metadata.dc.description.abstract[].value
The Brighton Collaboration Viral Vector Vaccines Safety Working
                Group (V3SWG) was formed to evaluate the safety of live,
                recombinant viral vaccines incorporating genes from heterologous
                viruses inserted into the backbone of another virus (so-called
                "chimeric virus vaccines"). Many viral vector vaccines are in
                advanced clinical trials. The first such vaccine to be approved
                for marketing (to date in Australia, Thailand, Malaysia, and the
                Philippines) is a vaccine against the flavivirus, Japanese
                encephalitis (JE), which employs a licensed vaccine (yellow
                fever 17D) as a vector. In this vaccine, two envelope proteins
                (prM-E) of YF 17D virus were exchanged for the corresponding
                genes of JE virus, with additional attenuating mutations
                incorporated into the JE gene inserts. Similar vaccines have
                been constructed by inserting prM-E genes of dengue and West
                Nile into YF 17D virus and are in late stage clinical studies.
                The dengue vaccine is, however, more complex in that it requires
                a mixture of four live vectors each expressing one of the four
                dengue serotypes. This vaccine has been evaluated in multiple
                clinical trials. No significant safety concerns have been found.
                The Phase 3 trials met their endpoints in terms of overall
                reduction of confirmed dengue fever, and, most importantly a
                significant reduction in severe dengue and hospitalization due
                to dengue. However, based on results that have been published so
                far, efficacy in preventing serotype 2 infection is less than
                that for the other three serotypes. In the development of these
                chimeric vaccines, an important series of comparative studies of
                safety and efficacy were made using the parental YF 17D vaccine
                virus as a benchmark. In this paper, we use a standardized
                template describing the key characteristics of the novel
                flavivirus vaccine vectors, in comparison to the parental YF 17D
                vaccine. The template facilitates scientific discourse among key
                stakeholders by increasing the transparency and comparability of
                information. The Brighton Collaboration V3SWG template may also
                be useful as a guide to the evaluation of other recombinant
                viral vector vaccines.

# metadata.dc.relation.isformatof[].value
Reproducció del document publicat a:
                http://dx.doi.org/10.1016/j.vaccine.2014.10.004

# metadata.dc.source[].value
Articles publicats en revistes (ISGlobal)

# metadata.dc.title[].value
Live virus vaccines based on a yellow fever vaccine backbone:  Standardized template with key considerations for a risk/benefit                 assessment