• Corpus ID: 19562102

ive virus vaccines based on a yellow fever vaccine backbone : tandardized template with key considerations for a risk / benefit

@inproceedings{Monatha2014iveVV,
  title={ive virus vaccines based on a yellow fever vaccine backbone : tandardized template with key considerations for a risk / benefit},
  author={P. Monatha and Stephen J. Seligmanb and James S. Robertsonc and runo Guyd and Edward B. Hayese and Richard Condit and Jean Louis Exclerg and Marie Maci and Baevin Carbery and Robert T. Cheni},
  year={2014}
}

• P. Monatha, Stephen J. Seligmanb, +7 authors Robert T. Cheni
• Published 2014
• Biology

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 The findings, opinions, conclusions, and assertions contained in this consensus document are those of the individual members of the Working Group. They do not ecessarily represent the official positions of each participant’s organization (e.g., government, university, or corporations) and should not be construed to represent any gency determination or policy. This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-No Derivative Works License, which permits nonommercial use, distribution, and reproduction in any medium, provided the original author and source are credited. ∗ Corresponding author Tel.: [phone]; fax: [phone]. E-mail addresses: stephen [e-mail], [e-mail] (S.J. Seligman). 1 Current affiliation: PaxVax Inc., Redwood City, CA 94063 and Hookipa Biotech AG, Vienna, Austria. 2 Current affiliation: Retired. 3 Deceased. 4 See Acknowledgement for other V3SWG members. ttp://dx.doi.org/10.1016/j.vaccine.2014.10.004 264-410X/© 2014 Published by Elsevier Ltd. T.P. Monath et al. / Vaccine 33 (2015) 62–72 63 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.